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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Fertilization rates [ Time Frame: 24 hours ]
- 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.
- Pregnancy outcome [ Time Frame: 9 months ]
- 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.
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
|Paris, France, 75014|
|Principal Investigator:||Jean-philippe Wolf, MD||Embryology Department , Biology of Reproduction - . Cochin Hospital|