NCT02161861

Brief Summary

cFEE peptide improves the IVF fertilization rate in mouse and fertilization index in human. It improves sperm movement's parameters. It has been studied over 3 generations of mice and appears without any side effects. The Agence de la BioMédecine has given the authorization for testing the peptide in human IVF. It is expected to improve the fertilization rate, and thus provide more embryos per IVF attempt. 160 couples will be included over 15 months. Patient sperm parameters should be suitable for IVF. Female should be between 18 and 43 year old. Each cohort of eggs will be randomly distributed to one of the 2 groups The first group will be inseminated with 100000/ml motile spermatozoa. The second will be similarly inseminated but in a middle which will be supplemented with cFEE 100µM. Criteria: number of embryos in each group

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

September 8, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

April 28, 2014

Last Update Submit

May 25, 2020

Conditions

InfertilityPregnancy

Keywords

tripeptide FEEfertilization ratesembryosoocytes

Outcome Measures

Primary Outcomes (1)

  • Fertilization rates

    24 hours

Secondary Outcomes (3)

  • Embryo quality

    day 5

  • Pregnancy outcome

    9 months

  • Baby health

    Year one

Study Arms (2)

group cFEE

EXPERIMENTAL

The group cFEE will be similarly inseminated with 100000/ml motile spermatozoa and will be supplemented with cFEE 100µM during 18 hours. The cFEE will increase the fusiogenic capacities of a gamete,

Other: cFFE increase the fusiogenic capacities of a gamete

untreated group

NO INTERVENTION

control group

Interventions

cFFE increase the fusiogenic capacities of a gameteOTHER
Also known as: The cyclic tripeptide
group cFEE

Eligibility Criteria

Age18 Years - 43 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients eligible for in vitro fertilization except indication of ICSI. That is to say : the patients whose sperm has the following characteristics :
  • Sperm count over 107 spz /ml and Mobility \* ( a + b ) is greater than 15 %
  • Typical forms above 10%
  • Women aged 18 to 43 years.
  • Patients gave their informed written consent
  • People affiliated to a social security system

You may not qualify if:

  • Patients whose sperm indicates the use or ICSI
  • Patients who have not given their consent or without the consent of one of the two spouses
  • Ovarian failure , menopause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolf

Paris, 75014, France

Location

Related Publications (4)

  • Yuan R, Primakoff P, Myles DG. A role for the disintegrin domain of cyritestin, a sperm surface protein belonging to the ADAM family, in mouse sperm-egg plasma membrane adhesion and fusion. J Cell Biol. 1997 Apr 7;137(1):105-12. doi: 10.1083/jcb.137.1.105.

    PMID: 9105040BACKGROUND

  • 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

  • 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

  • Wolf JP, Bomsel M. Brevet international "Peptide augmentant la capacité fusiogène d'une gamète" Université Paris 13 et CNRS. N° d'enregistrement 03 13545 ; N° de publication 2 862 225. 2003

    BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Jean-philippe Wolf, MD

    Embryology Department , Biology of Reproduction - . Cochin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

June 12, 2014

Study Start

September 8, 2014

Primary Completion

October 1, 2015

Study Completion

April 1, 2016

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations

FR(1)