Clinical trial NCT04954274: Improvement of Live Babies Rates After ICSI, Using cpFT
Official title: Improvement of Live Babies Rates After ICSI, Using cpFT: Multicenter Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Infertility
Oocyte
Pregnancy
Keywords: Infertility
Femal infertility
Assisted Reproduction Technology outcome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 366
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Supplementation of the incubation medium with cFEE should improve the implantation rate and ART outcome.

As in France ICSI is widely used to achieve good fertilization rates, we decided to use ICSI to fertilize the egg, and the peptide:

1. to improve chromosome segregation during meiosis, and
2. to improve in vitro embryogenesis after ICSI. Hence the protocol includes an oocyte preincubation step prior to ICSI and a co incubation of the embryo with the molecule during blastocyst formation.

Hence our protocol includes:

1. - a preincubation of the decoronized oocytes with the peptide prior to ICSI, and
2. - a coincubation of the developing embryo with the molecule.

The principal criteria will be the live baby rate after the first embryo transfer (using the best embryo). As the oocyte loses its strength as the women is getting older, the main criteria will be evaluated for women under 37 years old.

Randomization: every couple will be randomly assigned to the Control or the Treated group.

Treated group: After egg retrieval, the oocyte will be decoronized and incubated prior to ICSI procedure into CSCM-C (Irvine) medium supplemented with the molecule.

Control group: similar protocol of incubation but without the molecule. After ICSI the zygote will be incubated until the blastocyste stage in CSCM-C medium (Irvine).

Embryo transfer will be limited to only one blastocyst, fresh or delayed after cryopreservation.

Eligibility criteria: Inclusion Criteria:

* Couples eligible for a first 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Live birth rate after the first embryo transfer
timeFrame: 28 months after the first inclusion
Secondary outcomes:
measure: Level of Metaphase II oocytes
timeFrame: Through study completion average 16 months
measure: Quality of the embryonic culture
timeFrame: 16 months after the first inclusion
measure: Evaluation of the kinetics of embryonic development when possible.
timeFrame: 16 months after the first inclusion
measure: Embryonic quality at the blastocyst stage
timeFrame: Day 5-6 after ICSI
measure: Quality of the embryos after vitrification
timeFrame: Day 5-6 after ICSI
measure: Implantation rate with positive Beta hCG after transfer
timeFrame: 20 months after the first inclusion
measure: Clinical pregnancy rates with cardiac activity
timeFrame: 22 months after the first inclusion
measure: The rate of miscarriages per pregnancy
timeFrame: 22 months after the first inclusion
measure: rate of abnormality on morphological ultrasounds
timeFrame: 28 months after the beginning of the study
measure: rate of neonatal abnormality
timeFrame: 28 months after the beginning of the study
measure: children's development
timeFrame: 45 months after the beginning of the study
measure: Weight of the placenta; Study of DNA, RNA, Western-Blot, Methylation, histological study
timeFrame: 9 months after the transfer
Other outcomes:
Locations:
city: Paris
country: France
facility: Department Biology of Reproduction, Hospital Cochin AP-HP
Study officials:
affiliation: AP-HP, Hospital Cochin
name: Jean Philippe Mr WOLF, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1093/humrep/dei241. Epub 2005 Aug 11.