Improving live birth rates after ICSI using a peptide supplement
Improvement of Live Babies Rates After ICSI, Using cpFT: Multicenter Prospective Randomized Clinical Trial
This study is testing if adding a special peptide to the care of eggs and embryos can help women under 37 who are using ICSI have more successful pregnancies.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 366 (estimated) |
| Ages | 18 Years to 36 Years |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04954274 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance live birth rates following intracytoplasmic sperm injection (ICSI) by supplementing the incubation medium of oocytes and embryos with a cyclic peptide called Fertiline. The study focuses on women under 37 years old, utilizing a randomized control design where couples will be assigned to either a treatment group receiving the peptide or a control group without it. The primary outcome will be the live birth rate after the first embryo transfer, with the protocol including preincubation of oocytes and co-incubation of embryos with the peptide during development. The trial is conducted at the Department of Biology of Reproduction at Hospital Cochin in Paris.
Who should consider this trial
Good fit: Ideal candidates for this study are couples seeking their first attempt at assisted reproduction, specifically women aged 18 to 36 and men aged 18 to 58.
Not a fit: Patients who may not benefit include those with early menopause, contraindications to ART, or those undergoing IVF or IUI treatments.
Why it matters
Potential benefit: If successful, this approach could significantly increase the chances of live births for couples undergoing ICSI.
How similar studies have performed: While the use of peptide supplements in ART is a novel approach, similar studies have shown promising results in improving reproductive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * 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
Where this trial is running
Paris
- Department Biology of Reproduction, Hospital Cochin AP-HP — Paris, France (Recruiting)
Study contacts
- Principal investigator: Jean Philippe Mr WOLF, MD-PhD — AP-HP, Hospital Cochin
- Study coordinator: Jean Philippe Mr WOLF, MD-PhD
- Email: jean-philippe.wolf@aphp.fr
- Phone: 01 58 41 37 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.