NCT04954274

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P50-P75 for phase_3

Timeline
15mo left

Started Jul 2021

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Jul 2021Jul 2027

First Submitted

Initial submission to the registry

April 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

July 29, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2027

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

5 years

First QC Date

April 29, 2021

Last Update Submit

November 21, 2025

Conditions

InfertilityOocytePregnancy

Keywords

InfertilityFemal infertilityAssisted Reproduction Technology outcome

Outcome Measures

Primary Outcomes (1)

  • Live birth rate after the first embryo transfer

    Demonstration of the improvement in the rate of live births after ICSI by supplementing the pre-ICSI incubation medium of oocytes and that of preimplantation embryos with cpFT (1µM) during the 1st embryo transfer in women under 37 years of age.

    54 months after the first randomization

Secondary Outcomes (12)

  • Level of Metaphase II oocytes

    During the randomization period, which is 42 months.

  • Quality of the embryonic culture

    42 months after the first randomization

  • Evaluation of the kinetics of embryonic development when possible.

    42 months after the first randomization

  • Embryonic quality at the blastocyst stage

    Day 5-6 after ICSI

  • Quality of the embryos after vitrification

    Day 5-6 after ICSI

  • +7 more secondary outcomes

Study Arms (2)

Fertiline group

EXPERIMENTAL

Treated by supplementation of the culture medium with the molecule.

Drug: Cyclic peptide Fertiline

Control group

NO INTERVENTION

No supplementation

Interventions

Cyclic peptide FertilineDRUG

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.

Also known as: cFEE
Fertiline group

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department Biology of Reproduction, Hospital Cochin AP-HP

Paris, 75014, France

Location

Related Publications (2)

  • 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.

    PMID: 18692807BACKGROUND

  • 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.

    PMID: 16096325BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Jean Philippe Mr WOLF, MD-PhD

    AP-HP, Hospital Cochin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: there will be two groups: one treated by supplementation of the culture medium with 1 Micromolar of the molecule, the other being the control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

July 8, 2021

Study Start

July 29, 2021

Primary Completion (Estimated)

July 29, 2026

Study Completion (Estimated)

July 29, 2027

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)