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

Cairo University (CU)

Status: Unknown

Conditions: Assisted Reproduction

Treatments: Procedure: Trophectoderm embryo biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT02412605

PGD2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women undergoing IVF/ICSI

Exclusion criteria

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

Trial design

5,000 participants in 3 patient groups

Fertile embryo biopsy

Description:

Fertile couples requesting sex selection for family balancing

Treatment:

Procedure: Trophectoderm embryo biopsy

Infertile embryo biopsy

Description:

Infertile women having embryo biopsy

Treatment:

Procedure: Trophectoderm embryo biopsy

IVF/ICSI

Description:

Infertile women undergoing IVF/ICSI without embryo biopsy