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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.
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:
Hence our protocol includes:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fertiline group | Experimental | Treated by supplementation of the culture medium with the molecule. |
|
| Control group | No Intervention | No supplementation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclic peptide Fertiline | Drug | 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. |
| 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. | 54 months after the first randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Metaphase II oocytes | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Philippe Mr WOLF, MD-PhD | AP-HP, Hospital Cochin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department Biology of Reproduction, Hospital Cochin AP-HP | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18692807 | Background | 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. | |
| 16096325 | Background | 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. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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.
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| 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. | 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. | 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 | This criterion will be evaluated only for the first embryo transfer of each enrolled couple. | 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. | 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. | 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. | 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. | 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. | 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 | 54 months after the first randomization |