Clinical trial NCT02412605: Effect of Trophectoderm Biopsy for Sex Selection on the Pregnancy and Miscarriage Rates of Women Undergoing IVF/ICSI
Official title: Effect of Trophectoderm Biopsy for Sex Selection on the Pregnancy and Miscarriage Rates of Women Undergoing IVF/ICSI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Assisted Reproduction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women who had IVF/ICSI over the past 3 years in Dar AlTeb subfertility centre will be included in the study

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.

Eligibility criteria: Inclusion Criteria:

* Women undergoing IVF/ICSI

Exclusion Criteria:

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

Primary outcomes:
measure: Clinical pregnancy
timeFrame: 5 weeks after embryo transfer
Secondary outcomes:
measure: Miscarriage
timeFrame: 24 weeks after embryo transfer
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Dar AlTeb subfertility centre
Study officials:
References:
citation: 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.
citation: Rubino P, Cotarelo RP, Alteri A, Rega E, Vigano 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. No abstract available.