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Efficiency of Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts in In Vitro Fertilization

NCT04758819 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2024-01-19

No results posted yet for this study

Summary

Preimplantation embryo aneuploidy is a major source of adverse outcomes in human reproduction since it leads to implantation failure, early pregnancy loss or severe chromosomal diseases. The risk of embryos aneuploidy is drastically increased after 35 years old. The intra uterine transfer of euploid embryos assessed through such techniques as next-generation sequencing (NGS) based Comprehensive chromosomal Testing of Trophectoderm (TE) biopsies of Blastocysts (CTTEB), may improve implantation and live birth rates, and decrease miscarriage rates. But no randomized controlled trial (RCT) was ever performed to test the interest of CTTEB for women that really needed it (≥35 to ≤ 41 years old). In this multicentre randomized-controlled-trial, the investigators will compare live birth rate obtained after the first single frozen-thawed blastocyst transfer cycle following the freeze-all-Intracytoplasmic sperm injection cycle in infertile and old couples between two different strategies of Day 5/6 blastocyst selection:

* Control group: morphological criteria (Istanbul consensus)
* Interventional group: international recommendations after CTTEB (www.pgdis.org; Newsletter May 27, 2019).

Conditions

Interventions

PROCEDURE

Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB)

In vitro Fertilization by ICSI then embryo culture until Day 5/6; all blastocysts with morphological scores compatible with TE biopsy and vitrification will be submitted to Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB) and vitrified.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Nelly Frydman, Pharm D, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
41 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04758819 on ClinicalTrials.gov