Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts to Improve Live Birth Rates After in Vitro Fertilization: a Prospective Randomized Trial

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 41
Healthy Volunteers: f
View:

⁃ Women :

• Age ≥35 to ≤ 41 years old (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)

• BMI=18-35 kg/m2 inclusive

• No intrauterine and/or endometrial abnormalities that would interfere with implantation or pregnancy (for instance polyp, fibroid, …)

• Use of ejaculated motile sperm (donated and/or cryopreserved sperm is allowed)

• Age ≤ 50 years old

• Primary or secondary infertility

• Dated and signed inform consent

• Affiliated to National Insurance

• French speaking, able to understand the study

⁃ Criteria after randomization

⁃ Couple having at least one blastocyst with morphological score on Day 5/6 of in vitro embryo development (blastocoel expansion ≥3 and inner cell mass graded A, B or C and trophectoderm graded A or B

Locations
Other Locations
France
Hôpital Jean Verdier
RECRUITING
Bondy
Hôpital Antoine Béclère
RECRUITING
Clamart
CHU Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU Dijon
RECRUITING
Dijon
Hôpital Arnaud de Villeneuve
RECRUITING
Montpellier
CHU Nantes
RECRUITING
Nantes
Hôpital Cochin
RECRUITING
Paris
Hopital Tenon
NOT_YET_RECRUITING
Paris
CHU Strasbourg
RECRUITING
Schiltigheim
Hôpital Foch
RECRUITING
Suresnes
Contact Information
Primary
Catherine Patrat, MD, PhD
catherine.patrat@aphp.fr
+33 1 58 41 37 34
Backup
Christelle Auger
christelle.auger@aphp.fr
+33 1 58 41 11 86
Time Frame
Start Date: 2021-07-12
Estimated Completion Date: 2026-01
Participants
Target number of participants: 700
Treatments
No_intervention: Control group
Embryo selection according to Day 5/6 usual morphological criteria (Istanbul consensus)
Experimental: Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts: CTTEB group
Trophectoderm cells will be analyzed by NGS. Culture media will also be stored for further non-invasive chromosomal testing. Embryo selection will be done according to international guidelines (www.pgdis.org; Newsletter May 27, 2019).
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov