Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT02510534
Status:
TERMINATED
Last Update Posted:
2016-09-23
First Post:
2015-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Luteal Progesterone Support on Pregnancy Rates With Combined Clomid/ Gonadotropin & IUI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}}, 'statusModule': {'whyStopped': 'unable to enroll participants who meet the criteria', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-22', 'studyFirstSubmitDate': '2015-07-24', 'studyFirstSubmitQcDate': '2015-07-26', 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on Pregnancy rate measured by detectable embryonic cardiac activity', 'timeFrame': '10 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.', 'detailedDescription': 'To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.\n\nPatients will be randomized in a treatment arm or control arm. The treatment arm receives the luteal progesterone support and the control arm does not. Each arm will have 260 patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-37\n* BMI 19-34 kg/m2\n* Day 2-3 Follicle stimulating hormone (FSH) less than 10IU/mL\n* Estradiol (E2) less than 80 pg/mL\n* Anti-mullerian hormone (AMH) more than 1.5 ng/mL; or antral follicle count (AFC) up to 10\n* Two patent fallopian tubes confirmed by hysterosalpingogram (HSG) or chromopertubation\n* Normal uterine cavity confirmed by HSG, saline sonohysterogram (SIS) or hysteroscopy\n\nExclusion Criteria:\n\n* Severe male factor (total count less than 10 million sperm)\n* Systemic diseases not limited to diabetes\n* Pregnancy within 3 months\n* More than 1 prior cycle of gonadotropin treatment\n* Any ovarian cyst \\>15mm that has persisted for \\> 1 month\n* Endometrioma and/or Endometriosis-stage III or IV\n* Submucosal uterine fibroids; untreated endometrial polyps \\>1 cm;abnormal reproductive tract bleeding\n* Intolerance or allergy to study drug\n* Substance abuse (including alcohol and tobacco)\n* History of chemotherapy (except for gestational conditions) or radiotherapy\n* Minors and those adults not capable of consenting on their own'}, 'identificationModule': {'nctId': 'NCT02510534', 'briefTitle': 'Effect of Luteal Progesterone Support on Pregnancy Rates With Combined Clomid/ Gonadotropin & IUI', 'organization': {'class': 'OTHER', 'fullName': 'Northwest Center for Infertility and Reproductive Endocrinology'}, 'officialTitle': 'A Prospective Randomized Trial to Study the Effect of Luteal Progesterone Support on Pregnancy Rates in Combined Clomiphene Citrate and Gonadotropin Ovulation Induction Protocol With Intrauterine Insemination.', 'orgStudyIdInfo': {'id': 'IVFFL001v2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'This arm receives Menopur 150 international units x 1 dose', 'interventionNames': ['Drug: Menopur 150 international units']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': 'This arm receives Menopur 150 international units x 1 dose and Endometrin 100mg twice a day x 14 days', 'interventionNames': ['Drug: Menopur 150 international units', 'Drug: Endometrin 100 mg']}], 'interventions': [{'name': 'Menopur 150 international units', 'type': 'DRUG', 'otherNames': ['Gonadotropin'], 'description': 'Menopur 150 international units given x 1 dose', 'armGroupLabels': ['Control', 'Treatment']}, {'name': 'Endometrin 100 mg', 'type': 'DRUG', 'otherNames': ['Progesterone'], 'description': 'Endometrin 100mg twice daily x 14 days', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33063', 'city': 'Margate', 'state': 'Florida', 'country': 'United States', 'facility': 'Ivf Florida', 'geoPoint': {'lat': 26.24453, 'lon': -80.20644}}], 'overallOfficials': [{'name': 'Daniel Christie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVF FL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwest Center for Infertility and Reproductive Endocrinology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}