Improvement of Live Babies Rates After ICSI, Using cpFT (FERTICSI)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infertility; Pregnancy; Oocyte
• Intervention / Treatment: Drug: Cyclic peptide Fertiline

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 366
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Department Biology of Reproduction, Hospital Cochin AP-HP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Couples eligible for a 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.
• 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, family genetic problems, diabetes, uterine partitions, synechiae adhesions, adenomyosis or any other contraindication judged as such by the investigator.
• ART with donation of gametes or embryos.
• Participant under guardianship or guardianship

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fertiline group; Treated by supplementation of the culture medium with the molecule.	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.; Other Names: cFEE
No Intervention: Control group; No supplementation

What is the study measuring?

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.	54 months after the first randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Jean Philippe Mr WOLF, MD-PhD, AP-HP, Hospital Cochin

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2021
• Primary Completion (Estimated): July 29, 2026
• Study Completion (Estimated): July 29, 2027

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Infertility; Femal infertility; Assisted Reproduction Technology outcome
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: P170706J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No