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Clinical Trials/NCT02412605
NCT02412605UnknownNot Applicable

Effect of Trophectoderm Biopsy for Sex Selection on the Pregnancy and Miscarriage Rates of Women Undergoing IVF/ICSI

Cairo University1 site in 1 country5,000 target enrollmentStarted: April 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
5,000
Locations
1
Primary Endpoint
Clinical pregnancy

Study Overview

Brief Summary

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.

Detailed Description

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.

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Women undergoing IVF/ICSI

Exclusion Criteria

  • Women with expected poor ovarian response according to the Bologna criteria.

Outcomes

Primary Outcomes

Clinical pregnancy

Time Frame: 5 weeks after embryo transfer

presence of a gestational sac in vaginal ultrasound

Secondary Outcomes

  • Miscarriage(24 weeks after embryo transfer)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

AbdelGany Hassan

Lecturer of Gynecology and Obstetrics

Cairo University

Study Sites (1)

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