Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT01185704
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2010-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062876', 'term': 'cetrorelix'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}, {'id': 'D015292', 'term': 'Glycoprotein Hormones, alpha Subunit'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D005640', 'term': 'Follicle Stimulating Hormone'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D007986', 'term': 'Luteinizing Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D013972', 'term': 'Thyrotropin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@merckgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Merck KGaA Communication Center', 'organization': 'Merck Serono, a division of Merck KGaA'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to end of study (15 days post last administration of study drug)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.', 'eventGroups': [{'id': 'EG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.', 'otherNumAtRisk': 65, 'otherNumAffected': 9, 'seriousNumAtRisk': 65, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.', 'otherNumAtRisk': 65, 'otherNumAffected': 14, 'seriousNumAtRisk': 65, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ovarian Hyperstimulation syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Adnexa uterin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oestradiol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ovarian Hyperstimulation syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Estradiol (E2) Levels on r-hCG Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '1668.86', 'spread': '862.62', 'groupId': 'OG000'}, {'value': '1672.80', 'spread': '835.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'r-hCG day (end of stimulation cycle [approximately 15 days])', 'unitOfMeasure': 'picogram/milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N" (number of participants analyzed) signifies those participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'title': 'LH levels (n=58, 62)', 'categories': [{'measurements': [{'value': '4.87', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '6.84', 'spread': '3.99', 'groupId': 'OG001'}]}]}, {'title': 'FSH levels (n=57, 59)', 'categories': [{'measurements': [{'value': '4.98', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '6.69', 'spread': '10.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'unitOfMeasure': 'International unit/liter (IU/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had received at least 1 dose of the study medication. N" (number of participants analyzed) signifies those participants who were evaluable for this measure. Here "n" signifies those participants who were evaluated for specified category.'}, {'type': 'SECONDARY', 'title': 'Serum Estradiol (E2) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.42', 'spread': '14.06', 'groupId': 'OG000'}, {'value': '68.79', 'spread': '116.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Serum Progesterone (P4) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '1.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'unitOfMeasure': 'nanomolar/liter (nmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Anti Mullerian Hormone (AMH) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.27', 'spread': '4.40', 'groupId': 'OG000'}, {'value': '7.18', 'spread': '4.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.55', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '2.49', 'spread': '1.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'r-hCG day (end of stimulation cycle [approximately 15 days])', 'unitOfMeasure': 'follicles', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Number and Quality of Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'title': 'Total number of oocytes', 'categories': [{'measurements': [{'value': '7.48', 'spread': '5.21', 'groupId': 'OG000'}, {'value': '8.11', 'spread': '5.55', 'groupId': 'OG001'}]}]}, {'title': 'Mature oocytes', 'categories': [{'measurements': [{'value': '2.52', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '4.43', 'groupId': 'OG001'}]}]}, {'title': 'Fractured oocytes', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Immature oocytes', 'categories': [{'measurements': [{'value': '0.98', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '2.55', 'groupId': 'OG001'}]}]}, {'title': 'Inseminated oocytes', 'categories': [{'measurements': [{'value': '3.06', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '4.52', 'spread': '4.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])', 'description': 'Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes.', 'unitOfMeasure': 'oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had received at least 1 dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '1462.50', 'spread': '537.85', 'groupId': 'OG000'}, {'value': '1221.35', 'spread': '478.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])', 'unitOfMeasure': 'international unit (IU)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Fertilized Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.22', 'spread': '30.66', 'groupId': 'OG000'}, {'value': '46.86', 'spread': '30.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])', 'description': 'Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope.', 'unitOfMeasure': 'percent fertilized oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Embryos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.18', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '3.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])', 'description': 'Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes.', 'unitOfMeasure': 'embryos', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had received at least 1 dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Blastocysts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])', 'description': 'Blastocyst is an embryo, five or six days after fertilization, with an inner cell mass, outer layer of trophectoderm and a fluid-filled blastocoele cavity.', 'unitOfMeasure': 'blastocysts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had received at least 1 dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Transferred Embryos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])', 'description': 'Embryo transfer is the procedure in which one or more embryos are placed in the uterus.', 'unitOfMeasure': 'transferred embryos', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had received at least 1 dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Implantation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.90', 'groupId': 'OG000'}, {'value': '32.25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])', 'description': 'Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.', 'unitOfMeasure': 'percent sacs per embryo', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])', 'description': 'Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had received at least 1 dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'OG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to end of study (15 days post last administration of study drug)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. To avoid the participant/event combination double-count AEs and SAEs are reported separately.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'FG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of ovarian response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Ovarian hyperstimulation syndrome risk', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Ectopic pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Day 1 Protocol', 'description': 'Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\\>=) 17 millimeter \\[mm\\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'BG001', 'title': 'Day 7 Protocol', 'description': 'Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \\>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '29.7', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '29.7', 'spread': '3.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-20', 'studyFirstSubmitDate': '2010-08-10', 'resultsFirstSubmitDate': '2013-03-25', 'studyFirstSubmitQcDate': '2010-08-19', 'lastUpdatePostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-02', 'studyFirstPostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estradiol (E2) Levels on r-hCG Day', 'timeFrame': 'r-hCG day (end of stimulation cycle [approximately 15 days])'}], 'secondaryOutcomes': [{'measure': 'Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels', 'timeFrame': 'Day 1'}, {'measure': 'Serum Estradiol (E2) Levels', 'timeFrame': 'Day 1'}, {'measure': 'Serum Progesterone (P4) Levels', 'timeFrame': 'Day 1'}, {'measure': 'Anti Mullerian Hormone (AMH) Levels', 'timeFrame': 'Day 0'}, {'measure': 'Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day', 'timeFrame': 'r-hCG day (end of stimulation cycle [approximately 15 days])'}, {'measure': 'Number and Quality of Oocytes Retrieved', 'timeFrame': 'Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])', 'description': 'Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes.'}, {'measure': 'Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)', 'timeFrame': 'Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])'}, {'measure': 'Percentage of Fertilized Oocytes Retrieved', 'timeFrame': 'Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])', 'description': 'Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope.'}, {'measure': 'Number of Embryos', 'timeFrame': 'Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])', 'description': 'Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes.'}, {'measure': 'Number of Blastocysts', 'timeFrame': 'Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])', 'description': 'Blastocyst is an embryo, five or six days after fertilization, with an inner cell mass, outer layer of trophectoderm and a fluid-filled blastocoele cavity.'}, {'measure': 'Number of Transferred Embryos', 'timeFrame': 'Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])', 'description': 'Embryo transfer is the procedure in which one or more embryos are placed in the uterus.'}, {'measure': 'Implantation Rate', 'timeFrame': '5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])', 'description': 'Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.'}, {'measure': 'Percentage of Participants With Clinical Pregnancy', 'timeFrame': '10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])', 'description': 'Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to end of study (15 days post last administration of study drug)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. To avoid the participant/event combination double-count AEs and SAEs are reported separately.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cetrorelix acetate; follitropin alfa; human chorionic-gonadotropin alfa; follicular maturation; pregnancy; ovarian stimulation'], 'conditions': ['Polycystic Ovarian Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of Cetrotide® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of the menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in assisted reproductive technology (ART).', 'detailedDescription': 'Polycystic ovarian syndrome population is an androgenic syndrome characterized by a wide spectrum of clinical manifestations such as obesity, hirsutism, insulin resistance, diabetes and presence of specific ultrasonic features.\n\nCetrotide®, cetrorelix acetate, is an antagonist of luteinizing-hormone-releasing hormone (LHRH). Cetrotide® is registered in 70 countries (including France) for the prevention of premature ovulation in subjects undergoing a controlled ovarian stimulation, followed by oocyte pick-up and ARTs. Ovitrelle®, active ingredient human chorionic-gonadotropin alfa, is administered to trigger final follicular maturation and luteinization after stimulation of follicular growth.\n\nOBJECTIVES\n\nPrimary objective:\n\n* To compare the hormonal level of plasmatic estradiol on the releasing day (day of r-hCG administration) induced by Cetrotide® 0.25 mg/day started on Day 1 (Group A: Day 1) or on Day 7 (Group B: Day 7) of the menstrual cycle (Day 0 (S0) or Day 6 (S6) of stimulation) in PCO subjects undergoing IVF/ICSI procedures.\n\nSecondary objectives:\n\n* To compare the hormonal changes during the stimulation induced by Cetrotide® in A and B Groups\n* To assess by ultrasound scans (US) the follicular development induced by Cetrotide® in A and B Groups\n* To assess biological and clinical outcomes induced by Cetrotide® in A and B Groups\n* To monitor safety of Cetrotide in A and B Groups\n\nThe trial will be conducted on an outpatient basis. Once each subject has met all eligibility criteria, they will be randomly assigned in one of the two treatment groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects with PCO or Polycystic ovary syndrome (PCOS) according to the revised 2003 Rotterdam Consensus\n* Female subjects suitable for IVF/ICSI, undergoing first or second attempt\n* 18-35 years old, Body Mass Index (BMI) less than or equal to 32, non-smoking at least from Visit 0 (V0)\n* Normal FSH value (less than 10 international unit per liter \\[IU/L\\]) on Day 3 of spontaneous cycle within 12 months prior to the trial\n* Anti Mullerian Hormone (AMH) value (greater than 1.5 nanogram per milliliter \\[ng/mL\\]) of a spontaneous cycle within 12 months prior to the trial or at least at V0\n* No history of active genito-urinary infection\n* Normal thyroid function (or adequate substitution for at least 3 months)\n* Negative cervical papanicolaou test within the last 12 months prior to study entry\n* No gonadotropins, for at least one month prior to the trial\n* No metformin therapy for at least one month prior to Visit 1 (V1)\n* Subject who is able to participate in the trial and has provided written, informed consent.\n\nExclusion Criteria:\n\n* Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term\n* Drilling 3 months prior to V0\n* Uterine malformation, diethylstilbestrol syndrome, synechia\n* Female subjects with World Health Organization (WHO) Type I or III anovulation\n* Female subjects with hyperprolactinemia\n* Female subjects with more than 2 recurrent miscarriages (early or late, and for any reasons)\n* Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus, for subject or partner\n* Abnormal gynecological bleeding of undetermined origin\n* History of major thromboembolic disease\n* Endometriosis (Grade III or IV)\n* Presence or history of malignant tumors and related treatment\n* Known case of tumors of the hypothalamus or pituitary gland\n* Clinically significant systemic disease or clinically significant abnormal hematology, chemistry, or urinalysis results at screening\n* Known allergic reaction or hypersensitivity to Cetrotide® or Ovitrelle®\n* Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years\n* Participation in another clinical trial within 3 months prior to study entry.'}, 'identificationModule': {'nctId': 'NCT01185704', 'acronym': 'ATTAC-PCO', 'briefTitle': 'Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Phase IIIb Randomized Open-label Study to Compare the Estradiol Level on the Releasing Day in Two Regimen of Cetrotide® 0.25 mg Used From Day 1 or From Day 7 of the Menstrual Cycle (Day 0 or Day 6 of Stimulation) in Polycystic Ovarian (PCO) Women in ART (IVF/ICSI).', 'orgStudyIdInfo': {'id': 'EMR200088-501'}, 'secondaryIdInfos': [{'id': '2007-007932-25', 'type': 'EUDRACT_NUMBER'}, {'id': 'INI 28091', 'type': 'OTHER', 'domain': 'Merck KGaA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Day 1 protocol', 'interventionNames': ['Drug: Cetrorelix acetate', 'Drug: Recombinant Human Choriogonadotropin (r-hCG)', 'Drug: Recombinant human follicle stimulating hormone (r-hFSH)']}, {'type': 'EXPERIMENTAL', 'label': 'Day 7 protocol', 'interventionNames': ['Drug: Cetrorelix acetate', 'Drug: Recombinant Human Choriogonadotropin (r-hCG)', 'Drug: Recombinant human follicle stimulating hormone (r-hFSH)']}], 'interventions': [{'name': 'Cetrorelix acetate', 'type': 'DRUG', 'otherNames': ['Cetrotide®'], 'description': 'Cetrotide® 0.25 mg will be administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \\[S0\\]) until r-hCG day (at least 2 follicles \\>=17 mm)', 'armGroupLabels': ['Day 1 protocol']}, {'name': 'Cetrorelix acetate', 'type': 'DRUG', 'otherNames': ['Cetrotide®'], 'description': 'Cetrotide® 0.25 mg will be administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \\[S6\\]) until r-hCG day (at least 2 follicles \\>=19 mm)', 'armGroupLabels': ['Day 7 protocol']}, {'name': 'Recombinant Human Choriogonadotropin (r-hCG)', 'type': 'DRUG', 'otherNames': ['Ovitrelle®'], 'description': 'The r-hCG will be administered subcutaneously as a single dose of 250 microgram (mcg) on r-hCG day', 'armGroupLabels': ['Day 1 protocol', 'Day 7 protocol']}, {'name': 'Recombinant human follicle stimulating hormone (r-hFSH)', 'type': 'DRUG', 'description': 'Recombinant human follicle stimulating hormone (r-hFSH) will be administered subcutaneously at a dose between 75 and 187.5 international unit (IU) once daily from Day 2 (Day 1 of stimulation period \\[S1\\]) until r-hCG day', 'armGroupLabels': ['Day 1 protocol', 'Day 7 protocol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Dr Etienne VARLAN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Lipha Santé'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Serono S.A.S, France', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}