Improvement of Live Babies Rates After ICSI, Using cpFT

NCT ID: NCT04954274

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-29
• Study Completion Date: 2027-07-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fertiline group

Treated by supplementation of the culture medium with the molecule.

Group Type: EXPERIMENTAL

Cyclic peptide Fertiline

Intervention Type: DRUG

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.

Control group

No supplementation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

cFEE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Philippe Mr WOLF, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Hospital Cochin

Locations

Department Biology of Reproduction, Hospital Cochin AP-HP

Paris, , France

Countries

France

References

Barraud-Lange V, Naud-Barriant N, Ducot B, Chambris S, Bomsel M, Wolf JP, Ziyyat A. Cyclic QDE peptide increases fertilization rates and provides healthy pups in mouse. Fertil Steril. 2009 May;91(5 Suppl):2110-5. doi: 10.1016/j.fertnstert.2008.05.088. Epub 2008 Aug 9.

Reference Type: BACKGROUND

PMID: 18692807 (View on PubMed)

Ziyyat A, Naud-Barriant N, Barraud-Lange V, Chevalier F, Kulski O, Lemkecher T, Bomsel M, Wolf JP. Cyclic FEE peptide increases human gamete fusion and potentiates its RGD-induced inhibition. Hum Reprod. 2005 Dec;20(12):3452-8. doi: 10.1093/humrep/dei241. Epub 2005 Aug 11.

Reference Type: BACKGROUND

PMID: 16096325 (View on PubMed)

Other Identifiers

P170706J

Identifier Type: -

Identifier Source: org_study_id