Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT01237535
Status:
UNKNOWN
Last Update Posted:
2010-11-09
First Post:
2010-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004967', 'term': 'Estrogens'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D007314', 'term': 'Insemination'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'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'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-08', 'studyFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2010-11-08', 'lastUpdatePostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Pregnancy', 'timeFrame': '4 weeks after insemintation', 'description': 'A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Unexplained infertility', 'Insemination', 'Luteal phase support', 'Ovarian stimulation'], 'conditions': ['Unexplained Infertility', 'Mild Male Factor']}, 'descriptionModule': {'briefSummary': 'This is a single center, 3 arms, prospective randomized controlled open study to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.\n\nPatients will be randomized into 3 groups:\n\n1. Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)\n2. Luteal support with estrogen + progesterone \\[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\\].\n3. No luteal support', 'detailedDescription': 'Study design:\n\nsingle center, 3 arms, prospective randomized controlled open study\n\nObjective:\n\nto determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.\n\nMethods:\n\nAll patients in all study groups will undergo a single insemination procedure and then will be randomized into 3 groups:\n\n1. Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)\n2. Luteal support with estrogen + progesterone \\[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\\].\n3. No luteal support\n\nLuteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived. A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test. If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Couples with diagnosis of unexplained infertility\n2. In their treatment cycle with ovarian stimulation and IUI using recombinant FSH in our institution.\n\nExclusion Criteria:\n\n1. female partners with one or more of the following:\n\n * previous ovarian surgery\n * one ovary\n * polycystic ovaries on ultrasound examination\n * other endocrine abnormalities (i.e., polycystic ovarian syndrome, thyroid disorders,hyperprolactinemia,6.hypogonadotropic hypogonadism)\n * past ovarian hyperstimulation or hyperstimulation during the study period\n * diminished ovarian reserve (basal FSH level \\>15 IU/mL)\n * age of \\>40 years\n2. sever male factor \\< 5 million total motile sperm on the day of insemination.'}, 'identificationModule': {'nctId': 'NCT01237535', 'briefTitle': 'Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Luteal Phase Support With Progesterone vs Estrogen and Progesterone on Pregnancy Rates in Ovarian Stimulation and Intrauterine Insemination Cycles: a Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'rmc005788ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Luteal support with progesterone only', 'description': 'Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.', 'interventionNames': ['Drug: Luteal support with progesterone only']}, {'type': 'EXPERIMENTAL', 'label': 'Luteal support with estrogen + progesterone', 'description': 'Luteal support with estrogen + progesterone \\[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\\].', 'interventionNames': ['Drug: Luteal support with estrogen + progesterone']}, {'type': 'NO_INTERVENTION', 'label': 'No luteal support', 'interventionNames': ['Procedure: Insemination without luteal support']}], 'interventions': [{'name': 'Luteal support with progesterone only', 'type': 'DRUG', 'description': 'Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel).Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.', 'armGroupLabels': ['Luteal support with progesterone only']}, {'name': 'Luteal support with estrogen + progesterone', 'type': 'DRUG', 'description': 'Luteal support with estrogen + progesterone \\[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\\].Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.', 'armGroupLabels': ['Luteal support with estrogen + progesterone']}, {'name': 'Insemination without luteal support', 'type': 'PROCEDURE', 'description': 'Routine insemination procedure without luteal support', 'armGroupLabels': ['No luteal support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49202', 'city': 'Petah Tikva', 'country': 'Israel', 'contacts': [{'name': 'Galia Oron, Dr', 'role': 'CONTACT', 'email': 'orong@clalit.org.il', 'phone': '972-3-9377492'}, {'name': 'Galia Oron, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Galia Oron', 'role': 'CONTACT', 'email': 'orong@clalit.org.il', 'phone': '972-3-9377492'}], 'overallOfficials': [{'name': 'Galia Oron, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Galia Oron', 'oldOrganization': 'Rabin medical center'}}}}