Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-02-22 @ 2:47 PM
Study NCT ID:
NCT02341703
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2015-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ovulation Induction in Clomiphene Citrate Resistant PCO Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007246', 'term': 'Infertility'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2015-01-14', 'studyFirstSubmitQcDate': '2015-01-16', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ovulation rate', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome', 'Infertility']}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin with that of combined letrozole-pioglitazone in ovulation induction in CC-resistant PCOS women', 'detailedDescription': 'Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the ACOG recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS. CC has a long half-life (2 weeks), and this may have a negative effect on the cervical mucus and endometrium, leading to discrepancy between ovulation and conception rates. There has been a search for a compound capable of inducing ovulation but devoid of the adverse antiestrogenic effects of CC. recent studies have suggested that letrozole, an aromatase inhibitor, does not possess the adverse antiestrogenic effects of CC and is associated with higher pregnancy rates than CC treatment in patients with PCOS.\n\nIn this study the investigators shall compare the effect of combined letrozole-metformin with that of combined letrozole-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.This will be a prospective comparative clinical trial in which 2 groups of women will be generated (groups A and B) using the sealed envelopes randomization method.Group A (50 women) will receive: letrozole 2.5 mg/day from 3rd day of the cycle for 5 days and (pioglitazone 15 mg + metformin 850 mg) once daily from 1st day of the cycle for 10 days. Group B (50 women) will receive letrozole 2.5 mg/day from 3rd day of the cycle for 5 days and metformin 500 mg three times daily from continuously untill pregncy occurrs. Ovulation will be monitored by vaginal ultrasound and serum estrogen and progesterone.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-40 years old\n* PCOS infertile women resistant to CC for 3 cycles\n\nExclusion Criteria:\n\n* Presence of medical disorders as diabetes, hypertension, cardiac problems, liver or kidney diseases, hyperprolactinemia or thyroid dysfunction\n* Use of gonadotropins before\n* Previous ovarian drilling\n* Presence of urinary symptoms especially bloody urine'}, 'identificationModule': {'nctId': 'NCT02341703', 'briefTitle': 'Ovulation Induction in Clomiphene Citrate Resistant PCO Women', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Letrozole-metformin Versus Letrozole-metformin-pioglitazone in PCO Clomiphene Citrate Resistant Women', 'orgStudyIdInfo': {'id': 'University Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'letrozole-metformin group', 'description': 'this group will receive letrozole 2.5 mg daily from day 3 of the cycle and for 5 days + metformin 500 mg three times daily from the first day of the cycle and continuous for three months unless pregnancy occurred. treatment will continue for 3 cycles unless pregnancy occurred.\n\nfor this group: transvaginal ultrasound will monitor follicular enlargement laboratory investigations in the form of day 3 FSH, LH, TSH and serum testosterone will be done day 12 E2 day 21 serum progesterone', 'interventionNames': ['Drug: letrozole-metformin', 'Radiation: transvaginal ultrasound', 'Other: laboratory investigations']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'letrozole-metformin-pioglitazone group', 'description': 'this group will receive letrozole 2.5 mg daily from day 3 of the cycle and for 5 days + (metformin 850 mg + pioglitazone 15 mg) once daily from the first day of the cycle and for 10 days. treatment will continue for 3 cycles unless pregnancy occurred.\n\nfor this group: transvaginal ultrasound will monitor follicular enlargement laboratory investigations in the form of day 3 FSH, LH, TSH and serum testosterone will be done day 12 E2 day 21 serum progesterone', 'interventionNames': ['Drug: letrozole-metformin-pioglitazone', 'Radiation: transvaginal ultrasound', 'Other: laboratory investigations']}], 'interventions': [{'name': 'letrozole-metformin', 'type': 'DRUG', 'otherNames': ['femara-cidophage'], 'description': 'letrozole 2.5 mg will be given daily from day 3 of the cycle for 5 days + metformin 500 mg three times daily continuously for 3 months unless pregnancy occurred', 'armGroupLabels': ['letrozole-metformin group']}, {'name': 'letrozole-metformin-pioglitazone', 'type': 'DRUG', 'otherNames': ['femara- bioglita plus'], 'description': 'letrozole will be given daily from day 3 of the cycle for 5 days + (metformin 850 mg + pioglitazone 15 mg) from the first day of the cycle for 10 days.', 'armGroupLabels': ['letrozole-metformin-pioglitazone group']}, {'name': 'transvaginal ultrasound', 'type': 'RADIATION', 'description': 'transvaginal ultrasound will be done from day 10 of the cycle and every other day for monitoring of follicular enlargement.', 'armGroupLabels': ['letrozole-metformin group', 'letrozole-metformin-pioglitazone group']}, {'name': 'laboratory investigations', 'type': 'OTHER', 'description': 'day 3: FSH, LH, TSH, and total testosterone day 12 serum E2 day 21 serum progesterone', 'armGroupLabels': ['letrozole-metformin group', 'letrozole-metformin-pioglitazone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'faculty of medicine, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ghada Abdel Fattah Abdel Moety, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor of Obstetrics and Gynecology', 'investigatorFullName': 'Ghada Abdel Fattah', 'investigatorAffiliation': 'Cairo University'}}}}