Improvement of Live Babies Rates After ICSI, Using cpFT

Infertility Clinical Trial

— FERTICSI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04954274
• Other study ID #: P170706J
• Status: Recruiting
• Phase: Phase 3
• Start date: July 29, 2021
• Est. completion date: July 29, 2026

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jean Philippe Mr WOLF, MD-PhD
• Phone: 01 58 41 37 31
• Email: jean-philippe.wolf[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Infertility
• Oocyte
• Pregnancy

Intervention

Drug:
• Cyclic peptide Fertiline
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.

Locations

Country	Name	City	State
France	Department Biology of Reproduction, Hospital Cochin AP-HP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

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

Outcome

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