Infertility Clinical Trial
— FERTICSIOfficial title:
Improvement of Live Babies Rates After ICSI, Using cpFT: Multicenter Prospective Randomized Clinical Trial
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.
Status | Recruiting |
Enrollment | 366 |
Est. completion date | July 29, 2026 |
Est. primary completion date | July 29, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Department Biology of Reproduction, Hospital Cochin AP-HP | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Level of Metaphase II oocytes | Through study completion average 16 months | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Implantation rate with positive Beta hCG after transfer | 20 months after the first inclusion | ||
Secondary | Clinical pregnancy rates with cardiac activity | 22 months after the first inclusion | ||
Secondary | The rate of miscarriages per pregnancy | 22 months after the first inclusion | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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