Infertility Clinical Trial
— FertilineOfficial title:
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
NCT number | NCT02161861 |
Other study ID # | P071002 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | September 8, 2014 |
Est. completion date | April 2016 |
Verified date | May 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 66 |
Est. completion date | April 2016 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 43 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Wolf | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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. — View Citation
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
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. — View Citation
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. Epub 2005 Aug 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fertilization rates | 24 hours | ||
Secondary | Embryo quality | 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. | day 5 | |
Secondary | Pregnancy outcome | 9 months | ||
Secondary | Baby health | 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. | Year one |
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