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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Assisted Reproduction

Intervention / Treatment
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* Procedure: Trophectoderm embryo biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing IVF/ICSI Exclusion Criteria: Women with expected poor ovarian response according to the Bologna criteria.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fertile embryo biopsy<br>Fertile couples requesting sex selection for family balancing | Procedure: Trophectoderm embryo biopsy<br>* 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.<br>|
| Infertile embryo biopsy<br>Infertile women having embryo biopsy | Procedure: Trophectoderm embryo biopsy<br>* 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.<br>|
| IVF/ICSI<br>Infertile women undergoing IVF/ICSI without embryo biopsy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | presence of a gestational sac in vaginal ultrasound | 5 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage |  | 24 weeks after embryo transfer |