Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04954274

Improvement of Live Babies Rates After ICSI, Using cpFT

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infertility Genital Diseases Oocyte Pregnancy Urogenital Diseases

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Department Biology of Reproduction, Hospital Cochin AP-HP

Paris, 75014, France

About this study

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:

  • to improve chromosome segregation during meiosis, and
  • 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:

  • - a preincubation of the decoronized oocytes with the peptide prior to ICSI, and
  • - 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: cFEE

Primary outcomes

  1. Live birth rate after the first embryo transfer

    Time frame: 54 months after the first randomization

    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.

Secondary outcomes

  1. Level of Metaphase II oocytes

    Time frame: During the randomization period, which is 42 months.

  2. Quality of the embryonic culture

    Time frame: 42 months after the first randomization

    The measure evaluates the rate and number of fertilized eggs over the total number of metaphase 2 oocytes.

  3. Evaluation of the kinetics of embryonic development when possible.

    Time frame: 42 months after the first randomization

    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.

  4. Embryonic quality at the blastocyst stage

    Time frame: Day 5-6 after ICSI

    All the embryos that will reach the blastocyst stage will be evaluated according to the Gardner criteria.

  5. Quality of the embryos after vitrification

    Time frame: Day 5-6 after ICSI

    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

  6. Implantation rate with positive Beta hCG after transfer

    Time frame: 54 months after the first randomization

    This criterion will be evaluated only for the first embryo transfer of each enrolled couple.

  7. Clinical pregnancy rates with cardiac activity

    Time frame: until 54 months after the first randomization

    This criterion will be evaluated only for the first embryo transfer of each enrolled couple.

  8. The rate of miscarriages per pregnancy

    Time frame: until 54 months after the first randomisation

    This criterion will be evaluated only for the first embryo transfer of each enrolled couple.

  9. rate of abnormality on morphological ultrasounds

    Time frame: 51 months after the first randomisation

    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.

  10. rate of neonatal abnormality

    Time frame: 54 months after the first randomisation

    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.

  11. children's development

    Time frame: 72 months after the beginning of the study

    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.

  12. Weight of the placenta; Study of DNA, RNA, Western-Blot, Methylation, histological study

    Time frame: 54 months after the first randomization

    This outcome concerns patientes who give birth in the maternity ward of the Cochin hospital

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: FERTICSI

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jul 8, 2021
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.