Skip to main content
OpenTrials
Completed

NCT Number: NCT03062969

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Genital Diseases Preimplantation Genetic Screening Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cleavage stage biopsy group

Procedure
  • intracytoplasmatic sperm injection (ICSI)- (Invitro Fertilization)IVF
  • Time lapse embryo culture
  • Cleavage stage biopsy
  • aCGH analysis
  • Fresh euploid embryo transfer

Trophectoderm biopsy group

Procedure
  • ICSI-IVF
  • Time lapse embryo culture
  • Day 3 zona pellucida opening
  • Trophectoderm biopsy
  • aCGH analysis
  • Frozen-thawed euploid embryo transfer

Primary outcomes

  1. Ongoing clinical pregnancy rate

    Time frame: 20 weeks after embryo transfer

    Clinical pregnancy confirmed by ultrasound

Secondary outcomes

  1. Implantation Rate

    Time frame: 6 weeks after embryo transfer

    Embryos implanted confirmed by ultrasound

  2. Number of available euploid blastocysts per cycle

    Time frame: Up to 15 days after embryo biopsy

    Transferable or vitrified euploid blastocysts

  3. Miscarriage Rate

    Time frame: Until 20 weeks after embryo transfer

Sponsors and collaborators

Lead sponsor

Fundacion Dexeus

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Feb 24, 2017
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.