AzTrials
AzTrials

InfertilityPhase 3FERTICSINCT04954274

Improvement of Live Babies Rates After ICSI, Using cpFT

A Phase 3 study testing Cyclic peptide Fertiline in people with Infertility and Oocyte, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 36 years, women only
Conditions the study is for
Infertility, Oocyte, Pregnancy
What is being tested?
Cyclic peptide Fertiline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
366 participants
Where
1 siteFrance
Study dates
29 Jul 2021to 29 Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 36 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Department Biology of Reproduction, Hospital Cochin AP-HP

    Paris, 75014

Other trials in France

About this study

Official 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.

Read the 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.

Being tested
Cyclic peptide Fertiline
Keywords
Infertility, Femal infertility, Assisted Reproduction Technology outcome
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cyclic peptide FertilineDrug

    Also called cFEE

    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.

Study groups in NCT04954274
Study groupRoleWhat they receive
Fertiline groupExperimentalTreated by supplementation of the culture medium with the molecule.
Receives: Drug: Cyclic peptide Fertiline
Control groupNo interventionNo supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 54 months after the first randomization

Secondary outcomes (12)

  1. Level of Metaphase II oocytes

    Measured: During the randomization period, which is 42 months.

  2. Quality of the embryonic culture

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

    Measured: 42 months after the first randomization

  3. 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.

    Measured: 42 months after the first randomization

  4. Embryonic quality at the blastocyst stage

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

    Measured: Day 5-6 after ICSI

  5. 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

    Measured: Day 5-6 after ICSI

  6. Implantation rate with positive Beta hCG after transfer

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

    Measured: 54 months after the first randomization

  7. Clinical pregnancy rates with cardiac activity

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

    Measured: until 54 months after the first randomization

  8. The rate of miscarriages per pregnancy

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

    Measured: until 54 months after the first randomisation

  9. 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.

    Measured: 51 months after the first randomisation

  10. 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.

    Measured: 54 months after the first randomisation

  11. 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.

    Measured: 72 months after the beginning of the study

  12. 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

    Measured: 54 months after the first randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2021
  2. Study start29 Jul 2021
  3. Primary completion29 Jul 2026 (estimated)
  4. Study completion29 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
366 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04954274
Sponsor's protocol ID
P170706J
Acronym
FERTICSI
Status last verified
Nov 2025
First submitted
29 Apr 2021
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18692807

  • 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.

    PubMed 16096325

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclic peptide Fertiline in people with Infertility and Oocyte, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth rate after the first embryo transfer (time frame: 54 months after the first randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04954274, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.

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