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Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study (Fertiline)

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ClinicalTrials.gov Identifier: NCT02161861
Recruitment Status : Terminated (the trial was discontinued for legislative reasons.)
First Posted : June 12, 2014
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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


Condition or disease Intervention/treatment Phase
Infertility Pregnancy Other: cFFE increase the fusiogenic capacities of a gamete Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
Actual Study Start Date : September 8, 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: group cFEE

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
Other Name: The cyclic tripeptide

No Intervention: untreated group
control group



Primary Outcome Measures :
  1. Fertilization rates [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Embryo quality [ Time Frame: day 5 ]
    The embryo quality will be assessed according to the number of blastomeres, the presence of cytoplasmic fragments, multinucleated blastomeres, they shape and regularity, and their cleavage rate. Data will be compared to the Z score classification for the zygote, and the Gardner classification for the blastocyste.

  2. Pregnancy outcome [ Time Frame: 9 months ]
  3. Baby health [ Time Frame: Year one ]
    Baby health will be assessed on data collected during the pregnancy by the OBGYN, the 6 month ultrasound examination, and the health of the baby at delivery. It will consider the APGAR index and its weight and stature. During the first year of life, the baby health will be assessed by the pediatrician's examination at 6 month and one year old.



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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161861


Locations
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France
Wolf
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-philippe Wolf, MD Embryology Department , Biology of Reproduction - . Cochin Hospital
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02161861    
Other Study ID Numbers: P071002
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Keywords provided by Assistance Publique - Hôpitaux de Paris:
tripeptide FEE
fertilization rates
embryos
oocytes
Additional relevant MeSH terms:
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Infertility