FERTICSIMolecule for Improved Live Birth Rates After ICSI in Women Under 37
This study aims to evaluate if adding a specific molecule to the incubation medium before ICSI can improve live birth rates in women under 37 after their first embryo transfer.
Cyclic peptide Fertiline
Urogenital Diseases
+ Genital Diseases
+ Infertility
Treatment Study
Summary
Study start date: July 29, 2021
Actual date on which the first participant was enrolled.This clinical trial aims to explore a new method to improve the chances of having a live birth after a procedure called ICSI, which is commonly used in France to help with fertilization. The study involves adding a special peptide to the fluid that surrounds the egg cells and developing embryos during certain stages of the process. This approach is designed to help the eggs divide their chromosomes better and to support the growth of embryos in a lab setting. The study specifically targets women under the age of 37, as younger eggs tend to have better outcomes, hoping to increase the live birth rate after the first embryo transfer. In this study, participants are divided randomly into two groups. In the treated group, after the eggs are retrieved, they are prepared by removing the outer layer and then are incubated with a special molecule before undergoing the ICSI process. The developing embryos are then also exposed to this molecule until they reach the blastocyst stage. In the control group, the eggs and embryos are treated similarly, but without the special molecule. The trial measures success by looking at how many live births occur after the first embryo transfer, with only one high-quality embryo being transferred at a time. This careful process aims to assess whether the addition of the peptide can lead to better outcomes for couples undergoing ICSI.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.366 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 36 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department Biology of Reproduction, Hospital Cochin AP-HP
Paris, FranceOpen Department Biology of Reproduction, Hospital Cochin AP-HP in Google Maps