The Transition From Blastomere to Trophectoderm Biopsy: Comparing Two PGS Strategies

Infertility Clinical Trial

Official title:

The Transition From Blastomere to Trophectoderm Biopsy: Comparing Two PGS Strategies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062969
• Other study ID #: FDS-PGS-01
• Status: Completed
• Phase: N/A
• First received: February 16, 2017
• Last updated: February 20, 2017
• Start date: January 1, 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Shortly after the implementation of Comprehensive Chromosome Screening (CCS) techniques for Preimplantation Genetic Screening (PGS) came the transition in biopsy timing. Trophectoderm biopsy is meant to overcome the limitations of cleavage stage biopsy and single cell analysis.

Description:

The investigators have recently introduced this new approach and a frozen-thawed policy of euploid blastocysts is routinely performed.

This is a single centre retrospective study in patients undergoing a PGS cycle. The aim of the study is to assess the results obtained in a PGS programme after the implementation of a new biopsy timing and transfer policy. Results obtained in PGS cycles with blastocyst biopsy and frozen-thawed embryo transfer were analysed in comparison to cycles with cleavage stage biopsy and fresh blastocyst transfer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: January 2017
• Est. primary completion date: February 28, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Own gametes

• PGS for: advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male factor, and previous affected pregnancies

Exclusion Criteria:

• PGS cycles with gamete donation

• Altered karyotypes

• Combined Preimplantation genetic diagnosis (PGD)+PGS cycles

Related Conditions & MeSH terms

• Infertility
• Preimplantation Genetic Screening

Intervention

Procedure:
• Cleavage stage biopsy group
intracytoplasmatic sperm injection (ICSI)- (Invitro Fertilization)IVF Time lapse embryo culture Cleavage stage biopsy aCGH analysis Fresh euploid embryo transfer
• Trophectoderm biopsy group
ICSI-IVF Time lapse embryo culture Day 3 zona pellucida opening Trophectoderm biopsy aCGH analysis Frozen-thawed euploid embryo transfer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing clinical pregnancy rate	Clinical pregnancy confirmed by ultrasound	20 weeks after embryo transfer
Secondary	Implantation Rate	Embryos implanted confirmed by ultrasound	6 weeks after embryo transfer
Secondary	Number of available euploid blastocysts per cycle	Transferable or vitrified euploid blastocysts	Up to 15 days after embryo biopsy
Secondary	Miscarriage Rate		Until 20 weeks after embryo transfer