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

Completed

• Conditions: Preimplantation Genetic Screening; Infertility
• Interventions: Procedure: Cleavage stage biopsy group; Procedure: Trophectoderm biopsy group

• Registration Number: NCT03062969
• Lead Sponsor: Institut Universitari Dexeus

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2016-02-28
• Study Completion: 2017-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-20
• Last Update Submitted: 2017-02-20
• Study First Posted: 2017-02-24
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 383

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cleavage stage biopsy group	Cleavage stage biopsy group	Patients undergoing a PGS cycle with single blastomere biopsy on day 3 and analysis using comparative genomic hybridation bacterial artificial chromosome (BAC) arrays (aCGH) If euploid blastocysts were available, patients underwent fresh blastocyst transfer on day 5.
Trophectoderm biopsy group	Trophectoderm biopsy group	Patients undergoing a PGS cycle with blastocyst biopsy on day 5-7 and analysis using comparative genomic hybridation bacterial artificial chromosome (BAC) arrays (aCGH). If euploid blastocysts were available, patients underwent frozen-thawed blastocyst transfer.

Primary Outcome Measures

Name	Time	Method
Ongoing clinical pregnancy rate	20 weeks after embryo transfer	Clinical pregnancy confirmed by ultrasound

Secondary Outcome Measures

Name	Time	Method
Number of available euploid blastocysts per cycle	Up to 15 days after embryo biopsy	Transferable or vitrified euploid blastocysts
Miscarriage Rate	Until 20 weeks after embryo transfer
Implantation Rate	6 weeks after embryo transfer	Embryos implanted confirmed by ultrasound