Suspended

FERTICSIMolecule for Improved Live Birth Rates After ICSI in Women Under 37

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Study Aim

This study aims to evaluate if adding a specific molecule to the incubation medium before ICSI can improve live birth rates in women under 37 after their first embryo transfer.

What is being tested

Cyclic peptide Fertiline

Drug
Who is being recruted

Urogenital Diseases

+ Genital Diseases

+ Infertility

From 18 to 36 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2021
See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 29, 2021

Actual date on which the first participant was enrolled.

This clinical trial aims to explore a new method to improve the chances of having a live birth after a procedure called ICSI, which is commonly used in France to help with fertilization. The study involves adding a special peptide to the fluid that surrounds the egg cells and developing embryos during certain stages of the process. This approach is designed to help the eggs divide their chromosomes better and to support the growth of embryos in a lab setting. The study specifically targets women under the age of 37, as younger eggs tend to have better outcomes, hoping to increase the live birth rate after the first embryo transfer. In this study, participants are divided randomly into two groups. In the treated group, after the eggs are retrieved, they are prepared by removing the outer layer and then are incubated with a special molecule before undergoing the ICSI process. The developing embryos are then also exposed to this molecule until they reach the blastocyst stage. In the control group, the eggs and embryos are treated similarly, but without the special molecule. The trial measures success by looking at how many live births occur after the first embryo transfer, with only one high-quality embryo being transferred at a time. This careful process aims to assess whether the addition of the peptide can lead to better outcomes for couples undergoing ICSI.

Official TitleImprovement of Live Babies Rates After ICSI, Using cpFT: Multicenter Prospective Randomized Clinical Trial
NCT04954274
Principal SponsorAssistance Publique - Hôpitaux de Paris
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

366 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 36 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesInfertility

Criteria

Inclusion Criteria: * Couples eligible for a 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 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 such as: hypertension, risk of eclampsia, family genetic problems, diabetes, uterine partitions, synechiae adhesions, adenomyosis or any other contraindication judged as such by the investigator. * ART with donation of gametes or embryos. * Participant under guardianship or guardianship

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Treated by supplementation of the culture medium with the molecule.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department Biology of Reproduction, Hospital Cochin AP-HP

Paris, FranceOpen Department Biology of Reproduction, Hospital Cochin AP-HP in Google Maps
SuspendedOne Study Center