Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-03 @ 8:12 AM
Study NCT ID:
NCT02412605
Status:
UNKNOWN
Last Update Posted:
2016-07-06
First Post:
2015-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Trophectoderm Biopsy for Sex Selection on the Pregnancy and Miscarriage Rates of Women Undergoing IVF/ICSI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-03', 'studyFirstSubmitDate': '2015-04-06', 'studyFirstSubmitQcDate': '2015-04-08', 'lastUpdatePostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy', 'timeFrame': '5 weeks after embryo transfer', 'description': 'presence of a gestational sac in vaginal ultrasound'}], 'secondaryOutcomes': [{'measure': 'Miscarriage', 'timeFrame': '24 weeks after embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Assisted Reproduction']}, 'referencesModule': {'references': [{'pmid': '25625041', 'type': 'BACKGROUND', 'citation': 'Greco E, Biricik A, Cotarelo RP, Iammarone E, Rubino P, Tesarik J, Fiorentino F, Minasi MG. Successful implantation and live birth of a healthy boy after triple biopsy and double vitrification of oocyte-embryo-blastocyst. Springerplus. 2015 Jan 14;4:22. doi: 10.1186/s40064-015-0788-y. eCollection 2015.'}, {'pmid': '25199461', 'type': 'BACKGROUND', 'citation': 'Rubino P, Cotarelo RP, Alteri A, Rega E, Vigano P, Giannini P. Trophectoderm biopsy performed by a double laser zona drilling: first safety evidence. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:344-5. doi: 10.1016/j.ejogrb.2014.08.019. Epub 2014 Aug 27. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Records of women who had trophectoderm biopsy for sex selection over the last 3 years will be reviewed and its outcome will be compared to other records of women who had IVF/ICSI without embryo biopsy.', 'detailedDescription': 'Records of women who had trophectoderm biopsy for sex selection over the last 3 years will be reviewed. Women will be divided into 3 groups: group 1 will comprise fertile women who had embryo biopsy for sex selection/family balancing, group 2 will comprise infertile women who had trophectoderm biopsy and group 3 will comprise infertile women who had IVF/ICSI without embryo biopsy.\n\nThe pregnancy and miscarriage rates of the groups will be compared. Before starting the embryo biopsy process couples were seen by a geneticist to assess the feasibility of the procedure for each couple. Couples were then counselled by a gynaecologist specialised in IVF to assess their fertility status and explain the whole procedure including the expected success rates and risks of IVF.\n\nWomen had standard pituitary down-regulation with GnRHa (Triptorelin 0.1mg, Decapeptyl® Ferring, Germany) day 7 after ovulation of previous cycle or on day 21 of the oral contraceptive cycles. GnRHa was continued for 2 weeks. Human menopausal gonadotrophin(HMG) (Merional ®IBSA) 150-300 IU/day was administered until the day of HCG administration, Transvaginal oocyte retrieval will be performed 34-36 h after the administration of HCG.\n\nDay 5 embryos were incubated in calcium/Magnesium free culture. A laser beam was used to produce a hole in the zona pellucida. Trophectoderm cells were collected by gentle suction using the biopsy pipette.\n\nFlorescent in situ hybridization of the trophectoderm nuclei with probes specific to the X- and Y-chromosomes was performed. the embryos were frozen and the cycles deferred.The embryos were thawed in the following cycle and if possible 2 embryos of the desired sex were transferred.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All women who had IVF/ICSI over the past 3 years in Dar AlTeb subfertility centre will be included in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing IVF/ICSI\n\nExclusion Criteria:\n\n* Women with expected poor ovarian response according to the Bologna criteria.'}, 'identificationModule': {'nctId': 'NCT02412605', 'briefTitle': 'Effect of Trophectoderm Biopsy for Sex Selection on the Pregnancy and Miscarriage Rates of Women Undergoing IVF/ICSI', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Trophectoderm Biopsy for Sex Selection on the Pregnancy and Miscarriage Rates of Women Undergoing IVF/ICSI', 'orgStudyIdInfo': {'id': 'PGD2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fertile embryo biopsy', 'description': 'Fertile couples requesting sex selection for family balancing', 'interventionNames': ['Procedure: Trophectoderm embryo biopsy']}, {'label': 'Infertile embryo biopsy', 'description': 'Infertile women having embryo biopsy', 'interventionNames': ['Procedure: Trophectoderm embryo biopsy']}, {'label': 'IVF/ICSI', 'description': 'Infertile women undergoing IVF/ICSI without embryo biopsy'}], 'interventions': [{'name': 'Trophectoderm embryo biopsy', 'type': 'PROCEDURE', 'description': 'Day 5 embryos were incubated in calcium/Magnesium free culture. A laser beam was used to produce a hole in the zona pellucida. Trophectoderm cells were collected by gentle suction using the biopsy pipette.\n\nFlorescent in situ hybridization of the trophectoderm nuclei with probes specific to the X- and Y-chromosomes was performed. the embryos were frozen and the cycles deferred.The embryos were thawed in the following cycle and if possible 2 embryos of the desired sex were transferred.', 'armGroupLabels': ['Fertile embryo biopsy', 'Infertile embryo biopsy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'AbdelGany MA Hassan, MRCOG, MD', 'role': 'CONTACT', 'email': 'abdelgany2@gmail.com', 'phone': '00217801604'}, {'name': 'Ahmed MA AwadAllah, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'AbdelGany MA Hassan, MRCOG, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mohamed MM Kotb, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dar AlTeb subfertility centre', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'AbdelGany M Hassan, MRCOG, MD', 'role': 'CONTACT', 'email': 'abdelgany2@gmail.com', 'phone': '+201017801604'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Gynecology and Obstetrics', 'investigatorFullName': 'AbdelGany Hassan', 'investigatorAffiliation': 'Cairo University'}}}}