NCT04954274

Improvement of Live Babies Rates After ICSI, Using cpFT

Improvement of Live Babies Rates After ICSI, Using cpFT: Multicenter Prospective Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years – 36 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Infertility
• Oocyte
• Pregnancy

Interventions

Type	Name	Description
DRUG	Cyclic peptide Fertiline	Upon retrieval, the oocyte will be decoronized and incubated prior to ICSI procedure into CSCC-M medium supplemented with the molecule. After ICSI, the zygote will be incubated in CSCM-C medium supplemented with the peptide.

Timeline

• Start date: 2021-07-29
• Primary completion: 2026-07-29
• Completion: 2027-07-29
• First posted: 2021-07-08
• Last updated: 2025-11-28

Locations

1 site across 1 country: France