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

• Conditions: Assisted Reproduction
• Interventions: Procedure: Trophectoderm embryo biopsy

• Registration Number: NCT02412605
• Lead Sponsor: Cairo University

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-03
• Last Update Posted: 2016-07-06
• Primary Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 5000

Inclusion Criteria

• Women undergoing IVF/ICSI

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infertile embryo biopsy	Trophectoderm embryo biopsy	Infertile women having embryo biopsy
Fertile embryo biopsy	Trophectoderm embryo biopsy	Fertile couples requesting sex selection for family balancing

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy	5 weeks after embryo transfer	presence of a gestational sac in vaginal ultrasound

Secondary Outcome Measures

Name	Time	Method
Miscarriage	24 weeks after embryo transfer

Trial Locations

Locations (1)

Dar AlTeb subfertility centre; 🇪🇬 Giza, Egypt