Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT02736032
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2016-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist
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': 'D004624', 'term': 'Embryo Transfer'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-12', 'studyFirstSubmitDate': '2016-03-30', 'studyFirstSubmitQcDate': '2016-04-12', 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '5 weeks after embryo transfer]', 'description': 'the detection of intrauterine gestational sac with positive pulsations'}, {'measure': 'Live birth rate', 'timeFrame': '9 months', 'description': 'Pregnancy ending with a live birth'}], 'secondaryOutcomes': [{'measure': 'Estradiol and Progesterone levels on day of start of progesterone supplementation', 'timeFrame': '12 to 20 days', 'description': 'The serum levels of estradiol and progesterone before embryo transfer'}, {'measure': 'Endometrial thickness on day of start of progesterone supplementation', 'timeFrame': '12 to 20 days', 'description': 'The endometrial thickness on the day of starting progesterone supplementation to transfer the embryos'}, {'measure': 'Number of days needed for adequate (> 8mm) endometrial thickness', 'timeFrame': '12 to 20 days', 'description': 'Number of days on external hormones to prepare endometrium'}, {'measure': 'Cycle cancellation: not related to thawing, thin endometrium, high P. OR related to embryos not surviving thawing.', 'timeFrame': '12 to 20 days', 'description': 'Cycle cancellation: not related to thawing, thin endometrium, high Progesterone. OR related to embryos not surviving thawing.'}, {'measure': 'Chemical pregnancy rate', 'timeFrame': '14 days after embryo transfer', 'description': 'positive serum Beta HCG 14 days after embryo transfer'}, {'measure': 'Implantation rate.', 'timeFrame': '5 weeks after embryo transfer', 'description': 'the ratio between the number of embryos transferred and the number of sacs'}, {'measure': 'Early miscarriage rate', 'timeFrame': '3 months', 'description': 'Pregnancy loss in the first 12 weeks gestation'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '3 months', 'description': 'Pregnancy ongoing beyond 12 weeks gestation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Traditionally, the use of GnRH-a suppression was considered essential for adequate endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. Several studies, however, have questioned its necessity for controlled endometrial preparation. Using a high dose of estradiol from day 1 of the cycle will suppress the gonadotroph, preventing folliculogenesis and excessive secretion of LH, allowing adequate endometrial preparation without GnRH-a.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-35 years\n* BMI 20-30\n* Regular menses.\n* No PCOS, no endometriosis\n* No uterine anomalies or lesions\n* No severe male factor\n* All grade 1 cleaved stage embryos\n\nExclusion Criteria:\n\n* Less than 20 or more than 35 years\n* BMI less than 20 or more than 30\n* Irregular cycles\n* PCOS or endometriosis\n* Uterine anomalies or lesions\n* Severe male factor\n* Poor quality embryos for transfer\n* Severe'}, 'identificationModule': {'nctId': 'NCT02736032', 'briefTitle': 'Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Cryopreserved-thawed Embryo Transfer in Down or Non-down Regulated Hormonally Controlled Cycles: a Prospective, Randomized Study', 'orgStudyIdInfo': {'id': '12016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'With GnRHa', 'description': 'Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using GnRHa followed by external estradiol and progesterone. The GnRHa depot from will be given on day 21 of the preceding cycle, on day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol followed up on day 12 of the cycle, if the endometrium is less than 8 mm, till day 15 of the cycle estradiol will be increased to 8 mg/day until 8 mm or more. Then, serum estradiol and progesterone levels are collected, and progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later.', 'interventionNames': ['Procedure: Embryo transfer', 'Procedure: Serum Estradiol and Progesterone levels', 'Drug: GnRH agonist', 'Drug: External Estradiol', 'Drug: Progesterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Without GnRHa', 'description': 'Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using external estradiol and progesterone only. On day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol and followed up on day 12 of the cycle, if the endometrium did not reach 8 mm, till day 15 of the cycle the dose will be increased to 8 mg/day until the endometrium is 8 or more mm. When the endometrium is ready, serum estradiol and progesterone levels are collected, then progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later.', 'interventionNames': ['Procedure: Embryo transfer', 'Procedure: Serum Estradiol and Progesterone levels', 'Drug: External Estradiol', 'Drug: Progesterone']}], 'interventions': [{'name': 'Embryo transfer', 'type': 'PROCEDURE', 'description': 'The transfer of cryopreserved-thawed embryos inside the uterus aiming to achieve pregnancy', 'armGroupLabels': ['With GnRHa', 'Without GnRHa']}, {'name': 'Serum Estradiol and Progesterone levels', 'type': 'PROCEDURE', 'description': 'Serum estradiol and serum progesterone levels in blood on the day of start of progesterone supplementation', 'armGroupLabels': ['With GnRHa', 'Without GnRHa']}, {'name': 'GnRH agonist', 'type': 'DRUG', 'otherNames': ['Decapeptyl SR'], 'description': 'GnRH agonist given on day 21 of the cycle preceding the embryo transfer', 'armGroupLabels': ['With GnRHa']}, {'name': 'External Estradiol', 'type': 'DRUG', 'otherNames': ['estradiol valerate of Cycloprogenova tablets'], 'description': 'Estradiol started on day1 of the cycle for endometrial prepartaion', 'armGroupLabels': ['With GnRHa', 'Without GnRHa']}, {'name': 'Progesterone', 'type': 'DRUG', 'otherNames': ['Cyclogest vaginal suppositories'], 'description': 'progesterone as luteal phase support start after endometrium is well prepared', 'armGroupLabels': ['With GnRHa', 'Without GnRHa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12411', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '12411', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Kamal Shaeer center of infertility', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'zip': '12411', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Nile IVF center', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Eman K Shaeer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nile Ivf Center, Cairo, Egypt', 'class': 'OTHER'}, {'name': 'Kamal Shaeer center of infertility', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Yasmin Ahmed Bassiouny', 'investigatorAffiliation': 'Cairo University'}}}}