Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-04-22 @ 1:05 PM
Study NCT ID:
NCT02479256
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2015-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002996', 'term': 'Clomiphene'}, {'id': 'D013629', 'term': 'Tamoxifen'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-15', 'studyFirstSubmitDate': '2015-04-13', 'studyFirstSubmitQcDate': '2015-06-19', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of ovulation.', 'timeFrame': 'Up to 4 weeks from starting treatment.', 'description': '* Transvaginal ultrasound done to:\n\n 1\\. Detect signs of ovulation: corpus luteum, fluid in cul-de-sac, collapse of the follicle size.\n* Serum progesterone will be measured in the mid luteal day of the cycle, where:\n\n 1. Level 6 ng/ml or 19 nmol/L indicates Ovulation.\n 2. Level \\<5 nmol/L suggests Ovulation did not occur.'}], 'secondaryOutcomes': [{'measure': 'Endometrial perfusion by using 3D- power Doppler (GE Medical system volouson E6, 5-7 MHz) in the mid luteal day of the cycle to assess endometrial receptivity.', 'timeFrame': 'Up to 4 weeks from starting treatment.', 'description': 'Endometrial perfusion by using 3D-power Doppler (GE Medical system volouson E6, 5-7 MHz) at Ain-Shams University Maternity Hospital will be done in the mid luteal day of the menstrual cycle to assess endometrial receptivity by measured:\n\n* Gray: mean Gray value.\n* Color angio: Flow index, Vascularization index, and Vascularization flow Index.'}, {'measure': 'Endometrial thickness and quality in the pre-ovulatory period.', 'timeFrame': 'Up to 4 weeks from starting treatment.', 'description': 'Transvaginal ultrasound will be done to:\n\nEvaluate endometrial thickness and quality pre-ovulatory: where the minimal endometrial thickness to achieve a pregnancy ranges from 4 to 7mm with a healthy trilaminar appearance.'}, {'measure': 'Number of growing follicles detected by transvaginal ultrasound.', 'timeFrame': 'Up to 4 weeks from starting treatment.', 'description': 'Transvaginal ultrasound will be done to:\n\nDetect mean follicular diameter in the days 10, 12, 14 and up to day 25 of the cycle.'}, {'measure': 'Pregnancy rate both clinical and biochemical.', 'timeFrame': 'Up to 8 weeks from starting treatment.', 'description': 'Transvaginal ultrasound done to:\n\n1. Evaluate endometrial thickness and quality in the mid luteal day of the cycle: where the optimal endometrial thickness to achieve a pregnancy ranging from 10 to 15mm with a healthy trilaminar appearance.\n2. Detect gestational and fetal pulsation.'}, {'measure': 'Patient compliance.', 'timeFrame': 'Up to 4 weeks from starting treatment.', 'description': 'Asking the participant about the empty strips.'}, {'measure': 'Adverse effects: such as headache, nausea, vomiting, breast tenderness, blurred vision, and ovarian enlargement or hyperstimulation.', 'timeFrame': 'Up to 4 weeks from starting treatment.', 'description': 'Asking the participant if there are any complaints about the side effects of the drugs.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PCOS', 'Induction of ovulation', 'Clomiphene citrate', 'Tamoxifen'], 'conditions': ['PCOS']}, 'descriptionModule': {'briefSummary': 'Comparison between Clomiphene citrate and Tamoxifen for induction of ovulation in women with PCOS.', 'detailedDescription': 'Participants fulfilling inclusion and exclusion criteria will be divided into two groups, each group containing 300 participants;\n\nGroup (A):\n\n300 participants will receive Clomiphene citrate oral tablets and placebo of Tamoxifen oral tablets.\n\nGroup (B):\n\n300 participants will receive Tamoxifen oral tablets and placebo of Clomiphene oral tablets.\n\nParticipants with abnormal menstrual history will receive two tablets of norethisterone 5mg tab (Steronate nor ®, hi pharm/Egypt) every12 hours for 5 days to withdraw period before starting the procedure.\n\nThen;\n\nGroup (A):\n\nWomen will receive one tablet of clomiphene citrate oral tablets 50 mg (Clomid®, aventis/Egypt) twice daily 12 hours apart (total dose 100 mg daily), and one tablet of placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses for 5 days, for only one menstrual cycle.\n\nGroup (B):\n\nWomen will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt) twice daily 12 hours apart (total dose 20 mg daily), and one tablet of placebo of clomiphene citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one menstrual cycle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary infertility.\n* Body mass index (BMI) between 25 and 30 Kg/m 2.\n* Polycystic ovary syndrome (using ESHRE/ASRM criteria).\n\nExclusion Criteria:\n\n* Secondary infertility.\n* Patients with BMI under 25 or over 30 Kg/m 2.\n* Hyper or hypothyroidism, or hyperprolactinemia.\n* Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs.\n* Intention to start a diet or a specific program of physical activity.\n* Organic pelvic diseases.\n* Tubal or male factor infertility.\n* Interval of earlier treatment with any of the fertility drugs of less than 6 months.\n* Contraindication to either:\n\n * Clomiphene citrate.\n * Tamoxifen.\n * HCG injection.'}, 'identificationModule': {'nctId': 'NCT02479256', 'briefTitle': 'Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Clomiphene Citrate Versus Tamoxifen for Induction of Ovulation in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '20092009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clomiphene citrate + placebo', 'description': 'Women will receive one tablet of clomiphene citrate oral tablets 50 mg (Clomid®, aventis/Egypt) twice daily 12 hours apart (total dose 100 mg daily), and one tablet of placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses for 5 days, for only one menstrual cycle.', 'interventionNames': ['Drug: Clomiphene citrate', 'Drug: Tamoxifen Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Tamoxifen + placebo', 'description': 'Women will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt) twice daily 12 hours apart (total dose 20 mg daily), and one tablet of placebo of clomiphene citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one menstrual cycle.', 'interventionNames': ['Drug: Tamoxifen', 'Drug: Clomiphene citrate placebo']}], 'interventions': [{'name': 'Clomiphene citrate', 'type': 'DRUG', 'otherNames': ['Clomid'], 'description': 'Women will receive one tablet of clomiphene citrate oral tablets 50 mg (Clomid®, aventis/Egypt) twice daily 12 hours apart (total dose 100 mg daily) from the 3rd day of the menses for 5 days, for only one menstrual cycle.', 'armGroupLabels': ['Clomiphene citrate + placebo']}, {'name': 'Tamoxifen Placebo', 'type': 'DRUG', 'description': 'Women will receive one tablet of placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses for 5 days, for only one menstrual cycle.', 'armGroupLabels': ['Clomiphene citrate + placebo']}, {'name': 'Tamoxifen', 'type': 'DRUG', 'description': 'Women will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt) twice daily 12 hours apart (total dose 20 mg daily) from 3rd day of the menses for 5 days, for only one menstrual cycle.', 'armGroupLabels': ['Tamoxifen + placebo']}, {'name': 'Clomiphene citrate placebo', 'type': 'DRUG', 'description': 'Women will receive one tablet of placebo of clomiphene citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one menstrual cycle.', 'armGroupLabels': ['Tamoxifen + placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Gasser M. El-Bishry, FRCOG', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Obstetrics and Gynaecology, Ain Shams University'}, {'name': 'Abdel-Latif G. El-Kholy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor of Obstetrics and Gynaecology, Ain Shams University'}, {'name': 'Mohamed S. Sweed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Obstetrics and Gynaecology, Ain Shams University'}, {'name': 'Diana N. Kolta, MB BCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident of Obstetrics and Gynaecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Mohamed S Sweed, MD', 'investigatorAffiliation': 'Ain Shams University'}}}}