Improvement of Live Babies Rates After ICSI, Using cpFT

Study Overview
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Brief Summary
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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
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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: to improve chromosome segregation during meiosis, and 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: - a preincubation of the decoronized oocytes with the peptide prior to ICSI, and - 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.

Official Title
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Improvement of Live Babies Rates After ICSI, Using cpFT: Multicenter Prospective Randomized Clinical Trial

Conditions
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Infertility, Oocyte, Pregnancy

Intervention / Treatment
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* Drug: Cyclic peptide Fertiline


Participation Criteria
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Eligibility Criteria
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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. Patients resumed after a first attempt by the couple. 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, viral risk, family genetic problems, diabetes, uterine partitions, synechiae adhesions, adenomyosis or any other contraindication judged as such by the investigator. AMP with donation of gametes or embryos. Frozen sperm. Participant under guardianship or guardianship

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fertiline group<br>Treated by supplementation of the culture medium with the molecule. | Drug: Cyclic peptide Fertiline<br>* Upon retrieval, the oocyte will be decoronized and incubated prior to ICSI procedure into CSCC-M medium supplemented with the molecule. After ICSI, the zygote will be incubated in CSCM-C medium supplemented with the peptide.<br>* Other names: cFEE;|
| No Intervention: Control group<br>No supplementation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate after the first embryo transfer | 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. | 28 months after the first inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Metaphase II oocytes |  | Through study completion average 16 months | 
| Quality of the embryonic culture | The measure evaluates the rate and number of fertilized eggs over the total number of metaphase 2 oocytes. | 16 months after the first inclusion | 
| Evaluation of the kinetics of embryonic development when possible. | 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. | 16 months after the first inclusion | 
| Embryonic quality at the blastocyst stage | All the embryos that will reach the blastocyst stage will be evaluated according to the Gardner criteria. | Day 5-6 after ICSI | 
| Quality of the embryos after vitrification | 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 | Day 5-6 after ICSI | 
| 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 | 
| The rate of miscarriages per pregnancy |  | 22 months after the first inclusion | 
| rate of abnormality on morphological ultrasounds | 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. | 28 months after the beginning of the study | 
| rate of neonatal abnormality | 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. | 28 months after the beginning of the study | 
| children's development | 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. | 45 months after the beginning of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, Femal infertility, Assisted Reproduction Technology outcome