Effect of Trophectoderm Biopsy for Sex Selection on the Pregnancy and Miscarriage Rates of Women Undergoing IVF/ICSI
1 other identifier
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 6, 2015
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedJuly 6, 2016
July 1, 2016
2.1 years
April 6, 2015
July 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy
presence of a gestational sac in vaginal ultrasound
5 weeks after embryo transfer
Secondary Outcomes (1)
Miscarriage
24 weeks after embryo transfer
Study Arms (3)
Fertile embryo biopsy
Fertile couples requesting sex selection for family balancing
Infertile embryo biopsy
Infertile women having embryo biopsy
IVF/ICSI
Infertile women undergoing IVF/ICSI without embryo biopsy
Interventions
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
All women who had IVF/ICSI over the past 3 years in Dar AlTeb subfertility centre will be included in the study
You may qualify if:
- Women undergoing IVF/ICSI
You may not qualify if:
- Women with expected poor ovarian response according to the Bologna criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Dar AlTeb subfertility centre
Giza, Egypt
Related Publications (2)
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.
PMID: 25625041BACKGROUNDRubino 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.
PMID: 25199461BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Gynecology and Obstetrics
Study Record Dates
First Submitted
April 6, 2015
First Posted
April 9, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2017
Last Updated
July 6, 2016
Record last verified: 2016-07