Improvement of Live Babies Rates After ICSI, Using cpFT
- Registration Number
- NCT04954274
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 366
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fertiline group Cyclic peptide Fertiline Treated by supplementation of the culture medium with the molecule.
- Primary Outcome Measures
Name Time Method Live birth rate after the first embryo transfer 28 months after the first inclusion Demonstration of the improvement in the rate of live births after ICSI by supplementing the pre-ICSI incubation medium of oocytes and that of preimplantation embryos with cpFT (1µM) during the 1st embryo transfer in women under 37 years of age.
- Secondary Outcome Measures
Name Time Method Level of Metaphase II oocytes Through study completion average 16 months Quality of the embryonic culture 16 months after the first inclusion The measure evaluates the rate and number of fertilized eggs over the total number of metaphase 2 oocytes.
Implantation rate with positive Beta hCG after transfer 20 months after the first inclusion Clinical pregnancy rates with cardiac activity 22 months after the first inclusion Embryonic quality at the blastocyst stage Day 5-6 after ICSI All the embryos that will reach the blastocyst stage will be evaluated according to the Gardner criteria.
The rate of miscarriages per pregnancy 22 months after the first inclusion Quality of the embryos after vitrification Day 5-6 after ICSI The percentage of Good and Top embryos after thawing will be compared to the grading for the same embryo before cryopreservation according to Gardner criteria
rate of neonatal abnormality 28 months after the beginning of the study It reports the percentage of neonatal baby examination showing an abnormality over the total number of neonatal baby examination performed for all the babies who will born during the study.
children's development 45 months after the beginning of the study It reports the percentage of one year old baby examinations showing an abnormality over the total number of one year old baby examinations performed for all the babies who will born during the study.
Evaluation of the kinetics of embryonic development when possible. 16 months after the first inclusion The embryos will be kept in an incubator with an embryoscope so that their cleavage sequences will be registered "when possible". The criteria will analysis the cleavage sequences of all embryos during preimplantation embryogenesis.
rate of abnormality on morphological ultrasounds 28 months after the beginning of the study It reports the percentage of morphological ultrasounds showing an abnormality in the fetus morphology on the total number of morphological ultrasounds performed for all the pregnancies depending of the study.
Weight of the placenta; Study of DNA, RNA, Western-Blot, Methylation, histological study 9 months after the transfer This outcome concerns patientes who give birth in the maternity ward of the Cochin hospital
Trial Locations
- Locations (1)
Department Biology of Reproduction, Hospital Cochin AP-HP
🇫🇷Paris, France