Improvement of Live Babies Rates After ICSI, Using cpFT
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 5, 2021
Trial Information
Current as of April 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new method to help improve the chances of having live babies for women under 37 years old who are undergoing a specific fertility treatment called ICSI (Intracytoplasmic Sperm Injection). The study is examining whether adding a special supplement, known as cpFT, to the environment where eggs and embryos are prepared can lead to higher birth rates after the first embryo transfer. The trial is currently looking for participants who are eligible for their first attempt at assisted reproduction and meet certain age and health criteria.
To be eligible for this trial, women need to be between 18 and 36 years old, and men must be between 18 and 58 years old. Couples must also be seeking help with fertility and planning to undergo the ICSI procedure. Participants will be closely monitored throughout the trial, and it’s important that they can follow the study requirements in France. This trial could provide valuable information on improving fertility treatments, so if you think you might qualify, it’s a good idea to discuss it with your doctor.
Gender
FEMALE
Eligibility 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
Trial Officials
Jean Philippe Mr WOLF, MD-PhD
Principal Investigator
AP-HP, Hospital Cochin
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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