Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-04 @ 2:37 PM
Study NCT ID:
NCT04610957
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2020-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': 'up to 24 weeks', 'description': 'defined as the presence of gestational sac containing fetal hearts on ultrasound scan'}], 'secondaryOutcomes': [{'measure': 'Endometrial thickness,', 'timeFrame': 'up to 24 weeks', 'description': 'endometrial thickness is used to monitor infertility treatment'}, {'measure': 'ovulation rate', 'timeFrame': 'up to 24 weeks', 'description': 'Ovulation rate was taken as the gold standard for assessment of ovulation induction result'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human chorionic gonadotropin', 'clomiphene Citrate', 'Isoflavonoids', 'polycystic ovary syndrome'], 'conditions': ['Ovulation Induction', 'Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': "This prospective, randomized clinical trial double blinded study, has been carried on 160 infertile patients seeking pregnancy in Gynecology and Obstetrics Department, Zagazig University Hospitals during the period from January 2019 to November 2019, the participants' randomizations were done and patients divided into two groups; group I: included 80 women receiving Clomiphene citrate (CC) plus Isoflavonoids. Group 2: included 80 women receiving Clomiphene citrate only", 'detailedDescription': 'Phytoestrogens continue to be of increasing interest because of their possible influence on the physiology of the reproductive tract.\n\nThe aim of Prospective randomized clinical trial study is to evaluate effect of adding isoflavonoids to clomiphene citrate during ovulation induction in women with PCOS on the endometrial thickness which has an impact on pregnancy rate.\n\nThis study included 160 infertile women seeking pregnancy and they were divided into two groups. Clomiphene is given orally at dose, one tablet twice per day (tablet 50 mg), from day 3 to day 7 for all patients (group I and group II),while phytoestrogens are given at dose, two tablets two times per day (tablet 800mg), from day 3 to day 12 only for group I, followed by HCG injection on attaining mature follicle(s) by trans-vaginal US scan with diameter ≥ 18 mm.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Patient aged 18- 35 years old with primary or secondary infertility\n\nExclusion Criteria:\n\n* Patient aged 18- 35 years old with primary or secondary infertility\n* Patient whose husband has a male factor of infertility.\n* Hepatic, renal, diabetic, thyroid or cardiovascular disorders.\n* Organic pelvic disease (uterine fibroids or ovarian cysts).\n* Abnormality detected by HSG as blocked tubes'}, 'identificationModule': {'nctId': 'NCT04610957', 'briefTitle': 'Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': '5111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The 1st group', 'description': 'included eighty (80) women receiving Clomiphene citrate (CC) in the form of (Clomid 50 mg tablet, Sanofi Aventis, France) at dose (100 mg/day in two divided doses, starting from day 3 to day 7 of the cycle), plus Phytoestrogens (Isoflavonoids) in the form of (RosaFem 800 mg tablet, DeluxLab, Egypt) at dose (1600 mg/day in two divided doses (each dose one tablet), starting from day 3 to day 12 of the cycle', 'interventionNames': ['Drug: Rosafem (FEMININE FORMULA)']}, {'type': 'EXPERIMENTAL', 'label': 'The 2nd group', 'description': 'included eighty (80) women receiving Clomiphene citrate only, at dose (100 mg/day, starting from day 3 to day 7 of the cycle).', 'interventionNames': ['Drug: Rosafem (FEMININE FORMULA)']}], 'interventions': [{'name': 'Rosafem (FEMININE FORMULA)', 'type': 'DRUG', 'description': 'Rosafem is the only phytoestrogen product with the convenient dose which provides significant improvement of menopausal related symptoms premenstrual syndrome symptoms', 'armGroupLabels': ['The 1st group', 'The 2nd group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23451', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FAlbasri', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident of Obstetrics and Gynecology, Alkhoms Hospital, Misurata University, Libya', 'investigatorFullName': 'FAlbasri', 'investigatorAffiliation': 'Zagazig University'}}}}