Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT01112358
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2010-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Lutropin Alfa in Women at Risk of Poor Response
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006379', 'term': 'Helping Behavior'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571801', 'term': 'follitropin alfa'}, {'id': 'D037101', 'term': 'Luteinizing Hormone, beta Subunit'}, {'id': 'C062876', 'term': 'cetrorelix'}, {'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D007986', 'term': 'Luteinizing Hormone'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@merckgroup.com', 'phone': '496151725200', 'title': 'Merck KGaA Communication Center,', 'organization': 'Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the end of stimulation (Day 2 up to Day 8)', 'unitOfMeasure': 'Oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the end of stimulation (Day 2 up to Day 8)', 'unitOfMeasure': 'Follicles', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'Oocytes Recovery Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the end of stimulation (Day 2 up to Day 8)', 'description': 'Oocytes recovery rate (oocytes per \\>14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles \\>14 mm in diameter.', 'unitOfMeasure': 'oocytes per >14 mm follicle', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Oocyte Nuclear Maturity Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the end of stimulation (Day 2 up to Day 8)', 'description': 'Oocyte nuclear maturity rate (metaphase II oocytes per retrieved oocyte) is defined as number of metaphase II oocytes divided by total number of oocytes retrieved.', 'unitOfMeasure': 'metaphase II oocytes/retrieved oocyte', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Fertilization Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.70', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)', 'description': 'The fertilization rate (2 pronuclei \\[PN\\] fertilized oocytes per inseminated oocyte) was defined as number of 2 PN fertilized oocytes divided by number of inseminated oocytes.', 'unitOfMeasure': '2PN fertilized oocyte/inseminated oocyte', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Embryos by Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)', 'description': 'Embryo quality was graded according to morphological classification of Veeck. Grade 1: even blastomeres with no fragmentation; Grade 2: even blastomeres with slight fragmentation (less than 20%); Grade 3: uneven size blastomeres with no fragmentation; Grade 4: even or uneven size blastomeres with moderate fragmentation (20-25%); and Grade 5: unrecognizable blastomeres with severe fragmentation (\\>50%).', 'unitOfMeasure': 'Embroys', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Embryos Transferred by In Vitro Fertilization (IVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)', 'unitOfMeasure': 'Embroys', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Pregnancy Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)', 'description': 'The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)', 'description': 'A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or heartbeat (fetal sac).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Implementation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.33'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.28'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)', 'description': 'Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred.', 'unitOfMeasure': 'Clinical pregnancy/embryo transferred', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Plasma Level of Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '1218', 'spread': '699', 'groupId': 'OG000'}, {'value': '1029', 'spread': '336', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the time of r-hCG administration (any days between Day 2 to Day 8)', 'unitOfMeasure': 'Picograms per milliliters (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Endometrial Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the time of r-hCG administration (any days between Day 2 to Day 8)', 'unitOfMeasure': 'millimeters (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Duration of Ovarian Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to Day 8', 'description': 'Duration of ovarian stimulation was defined as the time from start of study treatment to time of r-hCG administration.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'rFSH Cumulative Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '4338', 'spread': '1241', 'groupId': 'OG000'}, {'value': '4298', 'spread': '1137', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to Day 8', 'unitOfMeasure': 'IU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Plasma Levels of LH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the time of r-hCG administration (any days between Day 2 to Day 8)', 'unitOfMeasure': 'IU per liter (IU/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'OG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Day 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'FG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'BG001', 'title': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '34.4', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '34.65', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all participants who were randomly assigned to one of two treatment groups and received at least one dose.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2007-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2010-04-26', 'resultsFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2010-04-27', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-23', 'studyFirstPostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Oocytes Retrieved', 'timeFrame': 'At the end of stimulation (Day 2 up to Day 8)'}, {'measure': 'Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter', 'timeFrame': 'At the end of stimulation (Day 2 up to Day 8)'}, {'measure': 'Oocytes Recovery Rate', 'timeFrame': 'At the end of stimulation (Day 2 up to Day 8)', 'description': 'Oocytes recovery rate (oocytes per \\>14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles \\>14 mm in diameter.'}], 'secondaryOutcomes': [{'measure': 'Oocyte Nuclear Maturity Rate', 'timeFrame': 'At the end of stimulation (Day 2 up to Day 8)', 'description': 'Oocyte nuclear maturity rate (metaphase II oocytes per retrieved oocyte) is defined as number of metaphase II oocytes divided by total number of oocytes retrieved.'}, {'measure': 'Fertilization Rate', 'timeFrame': 'Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)', 'description': 'The fertilization rate (2 pronuclei \\[PN\\] fertilized oocytes per inseminated oocyte) was defined as number of 2 PN fertilized oocytes divided by number of inseminated oocytes.'}, {'measure': 'Number of Embryos by Quality', 'timeFrame': 'Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)', 'description': 'Embryo quality was graded according to morphological classification of Veeck. Grade 1: even blastomeres with no fragmentation; Grade 2: even blastomeres with slight fragmentation (less than 20%); Grade 3: uneven size blastomeres with no fragmentation; Grade 4: even or uneven size blastomeres with moderate fragmentation (20-25%); and Grade 5: unrecognizable blastomeres with severe fragmentation (\\>50%).'}, {'measure': 'Number of Embryos Transferred by In Vitro Fertilization (IVF)', 'timeFrame': 'Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)'}, {'measure': 'Number of Participants With Positive Pregnancy Test', 'timeFrame': 'Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)', 'description': 'The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test.'}, {'measure': 'Number of Participants With Clinical Pregnancy', 'timeFrame': 'Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)', 'description': 'A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or heartbeat (fetal sac).'}, {'measure': 'Implementation Rate', 'timeFrame': 'Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)', 'description': 'Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred.'}, {'measure': 'Plasma Level of Estradiol', 'timeFrame': 'At the time of r-hCG administration (any days between Day 2 to Day 8)'}, {'measure': 'Endometrial Thickness', 'timeFrame': 'At the time of r-hCG administration (any days between Day 2 to Day 8)'}, {'measure': 'Duration of Ovarian Stimulation', 'timeFrame': 'Randomization to Day 8', 'description': 'Duration of ovarian stimulation was defined as the time from start of study treatment to time of r-hCG administration.'}, {'measure': 'rFSH Cumulative Dose', 'timeFrame': 'Randomization to Day 8'}, {'measure': 'Plasma Levels of LH', 'timeFrame': 'At the time of r-hCG administration (any days between Day 2 to Day 8)'}, {'measure': 'Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled', 'timeFrame': 'Randomization to Day 8'}]}, 'conditionsModule': {'keywords': ['Lutropin alfa', 'Fertilization in vitro', 'Intracytoplasmic sperm injection', 'Reproductive techniques, assisted'], 'conditions': ['Ovarian Stimulation']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'M.J. Fernández Ramírez, A. Monzó, T. García-Gimeno, J.M. Rubio, V. Montañana, C. Duque, G. Herrero, A. Romeu. Role of LH administration during the follicullar phase in women with risk of low response in ovarian stimulation with FSH and cetrorelix for IVF, REVISTA IBEROAMERICANA DE FERTILIDAD, Vol. 23- nº 5 - Septiembre-Octubre 2006'}], 'seeAlsoLinks': [{'url': 'http://www.revistafertilidad.org/RecursosWEB/fertilidad/Fertil%20Sept-oct-trab-1%2006.pdf', 'label': 'Results publication in spanish language'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone \\[r-hLH\\]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone \\[r-FSH\\]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '38 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who were at risk of poor response by at least one of the following criteria: a) \\<3 follicles in last cycle, or less than or equal to (\\</=) 2 metaphase II oocytes, or estradiol (E2) \\<600 pg/mL; b) Cancellation of previous cycle; c) Early follicular serum Follicle-Stimulating Hormone (FSH) \\>8.5 milli IU/L\n* Participants with normal baseline luteinizing hormone and E2 levels\n* Regular menstrual cycles of 25-35 days\n* Presence of both ovaries and uterus able to withstand pregnancy\n\nExclusion Criteria:\n\n* Participants who had any clinically significant disease including known human immunodeficiency virus (HIV), hepatitis-B virus (HBV)/hepatitis-C virus (HCV) positivity\n* Participants with more than 3 previous assisted reproductive techniques (ART) cycles\n* Participants with polycystic ovaries or cyst of unknown etiology; unexplained gynecological bleeding\n* Participants who had any contraindication to being pregnant\n* Active substance abuse\n* Participants who had simultaneously participated in another clinical drug trial'}, 'identificationModule': {'nctId': 'NCT01112358', 'briefTitle': 'Lutropin Alfa in Women at Risk of Poor Response', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Lutropin Alfa (Luveris®) in Women at Risk of Poor Response Suppressed With Cetrorelix: an Exploratory Trial', 'orgStudyIdInfo': {'id': 'IMP26170 (INI25954)'}, 'secondaryIdInfos': [{'id': '2005-002229-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'r-FSH + r-hLH', 'description': 'Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist.', 'interventionNames': ['Drug: r-FSH', 'Drug: r-hLH', 'Drug: Analogous GnRH antagonist', 'Drug: r-hCG', 'Drug: Progesterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'r-FSH', 'description': 'Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG will be administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist.', 'interventionNames': ['Drug: r-FSH', 'Drug: Analogous GnRH antagonist', 'Drug: r-hCG', 'Drug: Progesterone']}], 'interventions': [{'name': 'r-FSH', 'type': 'DRUG', 'otherNames': ['Follitropin alfa; Gonal-F®'], 'description': 'r-FSH will be administered as specified in the arm description.', 'armGroupLabels': ['r-FSH', 'r-FSH + r-hLH']}, {'name': 'r-hLH', 'type': 'DRUG', 'otherNames': ['Lutropin alfa; Luveris®'], 'description': 'r-hLH will be administered as specified in the arm description.', 'armGroupLabels': ['r-FSH + r-hLH']}, {'name': 'Analogous GnRH antagonist', 'type': 'DRUG', 'otherNames': ['Cetrotide®'], 'description': 'Analogous GnRH antagonist will be administered as specified in the arm description.', 'armGroupLabels': ['r-FSH', 'r-FSH + r-hLH']}, {'name': 'r-hCG', 'type': 'DRUG', 'description': 'r-hCG will be administered as specified in the arm description.', 'armGroupLabels': ['r-FSH', 'r-FSH + r-hLH']}, {'name': 'Progesterone', 'type': 'DRUG', 'description': 'Progesterone will be administered as specified in the arm description.', 'armGroupLabels': ['r-FSH', 'r-FSH + r-hLH']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario de La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}