Study on Improving Live Birth Rates in Women Under 37 with Infertility Using cpFT During ICSI

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What is this study about?

This clinical trial is focused on studying infertility and aims to improve the chances of having a live baby after a procedure called Intracytoplasmic Sperm Injection (ICSI). The treatment being tested is a solution called cpFT, which contains an active substance known as cpFT trifluoroacetate. This solution is not given directly to patients but is added to the culture medium used in the laboratory to help with the development of eggs and embryos before they are transferred to the woman’s uterus.

The purpose of the study is to see if using cpFT can increase the rate of live births in women under 37 years of age who are undergoing their first embryo transfer. During the study, participants will undergo the standard ICSI procedure, but with the addition of cpFT to the culture medium. The study will last for a maximum of six days, during which the development of the eggs and embryos will be closely monitored. The study will compare the outcomes of those who receive the cpFT treatment with those who do not, to determine if there is a significant improvement in live birth rates.

Participants in the study will not receive the cpFT solution directly, as it is only used in the laboratory setting. The study will also look at various factors related to embryo development, such as the number of mature eggs, the quality of embryos, and the rate of successful pregnancies. The ultimate goal is to find a way to help more couples achieve a successful pregnancy and have a healthy baby through the use of this innovative treatment.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. Participants include couples requiring medically assisted reproduction, eligible for ICSI, with women aged 18 to 36 and men aged 18 to 58. Participants must use a specific culture medium and be affiliated with a social security system.

2 preparation for treatment

The study involves the use of a solution called cpFT. This solution is used to supplement the medium in which oocytes and preimplantation embryos are incubated before the first embryo transfer. The concentration of cpFT used is 1 micromolar (1µM).

3 embryo transfer

The primary goal is to improve the rate of live births after the first embryo transfer. The process involves monitoring the development of embryos and assessing their quality before transfer.

4 monitoring and follow-up

After the embryo transfer, several factors are monitored, including the number of oocytes collected, embryo development, and quality. The study also tracks pregnancy progress, including the presence of cardiac activity at 12 weeks, and any pregnancy-related complications.

5 birth and postnatal follow-up

The study continues to monitor outcomes at birth, including the baby’s weight, height, and head circumference. Pediatric consultations are conducted until the child is one year old to assess development using specific scales.

Who Can Join the Study?

Couples who need Medically Assisted Reproduction (help from doctors to have a baby).
Couples who are eligible for ICSI (a special procedure where a single sperm is injected directly into an egg to help with fertilization).
Women who are between 18 and 36 years old.
Men who are between 18 and 58 years old.
Use of CSCM-C culture medium from Biocare/Irvine, exclusively (a specific type of solution used in the lab to support the growth of embryos).
People who are part of a Social Security system (a government program that provides financial support and healthcare).

Who Cannot Join the Study?

Participants must be women under 37 years of age.
Participants must be experiencing infertility.
Participants must be eligible for a procedure called ICSI (Intracytoplasmic Sperm Injection), which is a type of fertility treatment.
Participants must not belong to a vulnerable population, which means they should not be in a group that needs special protection in research, like children or people with certain disabilities.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Hopital Saint Joseph	Marseille	France
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Hopital Beaujon	Clichy	France
Mbqphprtw Llk Bqmiom	Paris	France
Cmkxwi Hvfkvrgozbh dfv 4 vzmfso	Saint-Cloud	France
Cehgzgov dw ly Mrzpkr	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	29.07.2021

Trial locations

Investigated drugs:

Cpft Trifluoroacetate

cpFT is a special supplement used in this clinical trial to help improve the chances of having a live baby after a procedure called ICSI, which is a type of fertility treatment. In this study, cpFT is added to the liquid that surrounds the eggs before the ICSI procedure and also to the liquid that surrounds the embryos before they are placed into the womb. The goal is to see if using cpFT can help more women under the age of 37 have successful pregnancies and healthy babies.

Investigated diseases:

Infertility

Infertility – Infertility is a condition where an individual is unable to conceive after a year of regular, unprotected sexual intercourse. It can affect both men and women and may result from various factors, including hormonal imbalances, structural issues, or problems with sperm or egg production. In women, infertility may be due to ovulation disorders, blocked fallopian tubes, or uterine abnormalities. In men, it often involves low sperm count, poor sperm motility, or abnormal sperm shape. The condition can be temporary or permanent, depending on the underlying cause. Infertility can lead to emotional and psychological stress for those affected.

Trial ID:

2024-514350-78-00

Protocol code:

P170706J

NCT ID:

NCT05559398

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Improving Live Birth Rates in Women Under 37 with Infertility Using cpFT During ICSI

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?