Improvement of Live Babies Rates After ICSI, Using cpFT (NCT04954274) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Improvement of Live Babies Rates After ICSI, Using cpFT
France366 participantsStarted 2021-07-29
Plain-language 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.
Who can participate
Age range
18 Years – 36 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Live birth rate after the first embryo transfer
Timeframe: 54 months after the first randomization