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

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02412605
• Collaborator: (none)
• Enrollment: 5,000
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Assisted Reproduction	Procedure: Trophectoderm 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
• Anticipated Enrollment: 5000 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Effect of Trophectoderm Biopsy for Sex Selection on the Pregnancy and Miscarriage Rates of Women Undergoing IVF/ICSI
• Study Start Date: Apr 1, 2015
• Anticipated Primary Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Fertile embryo biopsy Fertile couples requesting sex selection for family balancing	Procedure: 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	Procedure: 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

Outcome Measures

Primary Outcome Measures

1. Clinical pregnancy [5 weeks after embryo transfer]

   presence of a gestational sac in vaginal ultrasound

Secondary Outcome Measures

1. Miscarriage [24 weeks after embryo transfer]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women undergoing IVF/ICSI

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dar AlTeb subfertility centre	Giza		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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, Viganò 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.

• Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
• ClinicalTrials.gov Identifier: NCT02412605
• Other Study ID Numbers: PGD2
• First Posted: Apr 9, 2015
• Last Update Posted: Jul 6, 2016
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Abortion, Spontaneous

Study Results

No Results Posted as of Jul 6, 2016