Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT02330757
Status:
UNKNOWN
Last Update Posted:
2023-10-30
First Post:
2015-01-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HRT Versus MOS for Endometrial Preparation Prior to FET in Non PCOS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D008596', 'term': 'Menotropins'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-27', 'studyFirstSubmitDate': '2015-01-01', 'studyFirstSubmitQcDate': '2015-01-01', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '6 weeks after embryo transfer', 'description': 'Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures'}], 'secondaryOutcomes': [{'measure': 'Implantation rate', 'timeFrame': '6 weeks after embryo transfer', 'description': 'Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos'}, {'measure': 'Miscarriage rate', 'timeFrame': '12 weeks gestational age', 'description': 'Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Frozen-thawed embryo transfer', 'FET protocols'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation prior to frozen-thawed embryo transfer (FET) in patients without polycystic ovarian syndrome (PCOS)', 'detailedDescription': 'Women will be randomly divided into two groups; one will be subjected to endometrial preparation by hormone replacement therapy (HRT) and the other will be subjected to minimal ovarian stimulation (MOS). Women in the HRT group will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is \\< 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started. Women in the MOS group will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle \\> 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours. In both groups, FET will be planned in the appropriate day according to the stage that the embryos have been cryopreserved in it.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women without PCOS as defined by the Rotterdam criteria.\n* Presence of at least 2 cryopreserved good quality cleavage-stage embryo (good quality cleavage-stage embryos display stage-specific cell division, have blastomeres of fairly equal size with few to no cytoplasmic fragments).\n\nExclusion Criteria:\n\n* PCOS or polycystic ovary on ultrasound scan.\n* Moderate or severe endometriosis.\n* Hydrosalpinx.\n* Uterine abnormalities or myoma.\n* Previous uterine surgery.'}, 'identificationModule': {'nctId': 'NCT02330757', 'briefTitle': 'HRT Versus MOS for Endometrial Preparation Prior to FET in Non PCOS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Hormone Replacement Therapy Versus Minimal Ovarian Stimulation for Endometrial Preparation Prior to Frozen-thawed Embryo Transfer in Non Polycystic Ovarian Syndrome Patients', 'orgStudyIdInfo': {'id': 'MSA2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HRT group', 'description': 'Women will be subjected to HRT using Estradiol valerate before FET', 'interventionNames': ['Drug: Estradiol valerate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MOS group', 'description': 'Women will be subjected to MOS using sequential clomiphene citrate and gonadotropin before FET', 'interventionNames': ['Drug: Sequential Clomiphene citrate and Gonadotropin']}], 'interventions': [{'name': 'Estradiol valerate', 'type': 'DRUG', 'otherNames': ['Cycloprogynova (white tablets)'], 'description': 'Women will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is \\< 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started.', 'armGroupLabels': ['HRT group']}, {'name': 'Sequential Clomiphene citrate and Gonadotropin', 'type': 'DRUG', 'otherNames': ['Sequential Clomid and Menogon'], 'description': 'Women will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle \\> 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours.', 'armGroupLabels': ['MOS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed S Abdelhafez, Dr', 'role': 'CONTACT', 'email': 'msabdelhafez@gmail.com', 'phone': '+201144523366'}], 'facility': 'Fertility Care Unit (FCU) in Mansoura University Hospital', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Private fertility care centers', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Mohamed S Abdelhafez, Dr', 'role': 'CONTACT', 'email': 'msabdelhafez@gmail.com', 'phone': '+201144523366'}], 'overallOfficials': [{'name': 'Mohamed S Abdelhafez, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohamed Sayed Abdelhafez', 'investigatorAffiliation': 'Mansoura University'}}}}