Improvement of Live Babies Rates After ICSI, Using cpFT

Last updated: July 30, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

3

Condition

Infertility

Pregnancy

Treatment

Cyclic peptide Fertiline

Clinical Study ID

NCT04954274
P170706J
  • Ages 18-36
  • Female

Study Summary

Demonstrate the improvement of the live births rate after ICSI by supplementing the pre-ICSI incubation medium of oocytes and that of preimplantation embryos with cpFT at the 1st embryo transfer for women under 37 years old.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Couples eligible for a first attempt at Assisted Reproduction (AMP).

  • Couples asking for Assisted Reproductive Technology, and requiring an ICS procedure.

  • Women aged 18 to 36 inclusive.

  • Men aged 18 to 58 inclusive

  • Use of CSCM-C culture medium from Biocare / Irvine, exclusively.

  • People affiliated to a Social Security scheme

Exclusion

Exclusion Criteria:

  • Lack of consent

  • Early menopause.

  • Couples under IVF or Intra Uterine Insemination treatment.

  • People unable to follow protocol visits in France.

  • Couple with a contraindication to treatment with ART.

  • Women with a contraindication to treatment with ART or an associated pathology suchas: hypertension, risk of eclampsia, family genetic problems, diabetes, uterinepartitions, synechiae adhesions, adenomyosis or any other contraindication judged assuch by the investigator.

  • ART with donation of gametes or embryos.

  • Participant under guardianship or guardianship

Study Design

Total Participants: 366
Treatment Group(s): 1
Primary Treatment: Cyclic peptide Fertiline
Phase: 3
Study Start date:
July 29, 2021
Estimated Completion Date:
July 29, 2026

Study Description

Supplementation of the incubation medium with cFEE should improve the implantation rate and ART outcome.

As in France ICSI is widely used to achieve good fertilization rates, we decided to use ICSI to fertilize the egg, and the peptide:

  1. to improve chromosome segregation during meiosis, and

  2. to improve in vitro embryogenesis after ICSI. Hence the protocol includes an oocyte preincubation step prior to ICSI and a co incubation of the embryo with the molecule during blastocyst formation.

Hence our protocol includes:

1. 

   -  a preincubation of the decoronized oocytes with the peptide prior to ICSI, and

2. 

   -  a coincubation of the developing embryo with the molecule.

The principal criteria will be the live baby rate after the first embryo transfer (using the best embryo). As the oocyte loses its strength as the women is getting older, the main criteria will be evaluated for women under 37 years old.

Randomization: every couple will be randomly assigned to the Control or the Treated group.

Treated group: After egg retrieval, the oocyte will be decoronized and incubated prior to ICSI procedure into CSCM-C (Irvine) medium supplemented with the molecule.

Control group: similar protocol of incubation but without the molecule. After ICSI the zygote will be incubated until the blastocyste stage in CSCM-C medium (Irvine).

Embryo transfer will be limited to only one blastocyst, fresh or delayed after cryopreservation.

Connect with a study center

  • Department Biology of Reproduction, Hospital Cochin AP-HP

    Paris, 75014
    France

    Active - Recruiting

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