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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
366
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.
Department Biology of Reproduction, Hospital Cochin AP-HP
Paris, France
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.
Time frame: 54 months after the first randomization
Level of Metaphase II oocytes
Time frame: During the randomization period, which is 42 months.
Quality of the embryonic culture
The measure evaluates the rate and number of fertilized eggs over the total number of metaphase 2 oocytes.
Time frame: 42 months after the first randomization
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 analyze the cleavage sequence of all embryos during preimplantation embryogenesis.
Time frame: 42 months after the first randomization
Embryonic quality at the blastocyst stage
All the embryos that will reach the blastocyst stage will be evaluated according to the Gardner criteria.
Time frame: 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
Time frame: Day 5-6 after ICSI
Implantation rate with positive Beta hCG after transfer
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
This criterion will be evaluated only for the first embryo transfer of each enrolled couple.
Time frame: 54 months after the first randomization
Clinical pregnancy rates with cardiac activity
This criterion will be evaluated only for the first embryo transfer of each enrolled couple.
Time frame: until 54 months after the first randomization
The rate of miscarriages per pregnancy
This criterion will be evaluated only for the first embryo transfer of each enrolled couple.
Time frame: until 54 months after the first randomisation
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. This creterion will be assessed for all transfers that occurred during the randomization period and for the following 3 months in the case of deferred transfers.
Time frame: 51 months after the first randomisation
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. This criterion will be assessed for all transfers that occurred during the randomization period and for the following 3 months in the case of deferred transfers.
Time frame: 54 months after the first randomisation
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. This criterion will be assessed for all transfers that occurred during the randomization period and for the following 3 months in the case of deferred transfers.
Time frame: 72 months after the beginning of the study
Weight of the placenta; Study of DNA, RNA, Western-Blot, Methylation, histological study
This outcome concerns patientes who give birth in the maternity ward of the Cochin hospital
Time frame: 54 months after the first randomization