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

February 20, 2017 updated by: Lluc Coll Lujan, Institut Universitari Dexeus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

383

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing a PGS cycle with own gametes for any of the following indications: advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male factor, and previous affected pregnancies.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
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.
Procedure: Trophectoderm biopsy group
  • ICSI-IVF
  • Time lapse embryo culture
  • Day 3 zona pellucida opening
  • Trophectoderm biopsy
  • aCGH analysis
  • Frozen-thawed euploid embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing clinical pregnancy rate
Time Frame: 20 weeks after embryo transfer
Clinical pregnancy confirmed by ultrasound
20 weeks after embryo transfer

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

February 28, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDS-PGS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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