Effect of Trophectoderm Biopsy for Sex Selection on the Pregnancy and Miscarriage Rates of Women Undergoing IVF/ICSI
NCT ID: NCT02412605
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
5000 participants
OBSERVATIONAL
2015-04-30
Brief Summary
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Detailed Description
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The 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.
Women 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.
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.
Florescent 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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Fertile embryo biopsy
Fertile couples requesting sex selection for family balancing
Trophectoderm embryo biopsy
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.
Florescent 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.
Infertile embryo biopsy
Infertile women having embryo biopsy
Trophectoderm embryo biopsy
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.
Florescent 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.
IVF/ICSI
Infertile women undergoing IVF/ICSI without embryo biopsy
No interventions assigned to this group
Interventions
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Trophectoderm embryo biopsy
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.
Florescent 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
40 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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AbdelGany Hassan
Lecturer of Gynecology and Obstetrics
Locations
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Dar AlTeb subfertility centre
Giza, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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PGD2
Identifier Type: -
Identifier Source: org_study_id
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