Status:
COMPLETED
Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Reproductive Medicine
Eligibility:
FEMALE
18-38 years
Phase:
NA
Brief Summary
A prospective, randomized, controlled, open two-arm study to evaluate the interest of the pre-conceptional endometrial immune profiling to increase birth rates.
Detailed Description
Birth rates following an embryo transfer with a mean of two embryos transferred stagnate around 23% per transfer (annual report of the Agency of Biomedicine). Some estimates that half of infertile pat...
Eligibility Criteria
Inclusion
- Infertile patients will be included at the beginning of their medical care in reproduction once the indication to perform either an IVF with or without ICSI has been established. The indication for IVF will be: tubal infertility, endometriosis, ovarian dysovulation with failure of intra-uterine insemination, idiopathic infertility The indication for ICSI will be: male infertility (oligo-astheno-teratospermia), previous failure of oocytes fertilization in IVF
- Patients should be younger than 38 years old (Age \< 38)
- with a normal ovarian reserve (AMH\>1.5ng/ml, FSH\<10 IU/l on day-3, antral follicles count (AFC) over 6 on day-3 of the cycle by ultrasound)
- The range of the IVF or ICSI attempt should be lower than 3 or equal at 2 (first or second IVF/ICSI). If a live birth occurred in the past by IVF/ICSI, the range of the new attempt is 1.
- With a signed informed and consent form
- With medical insurance
Exclusion
- Azoospermia or cryptozoospermia (Patient's partner)
- IVF/ICSI attempt scheduled in another ART unit
- Contraindication to any experimental treatment (Cortancyl, Intralipids, Human Chorionic Gonadotropin)
- Maternal serology positive for hepatite C or B
Key Trial Info
Start Date :
October 30 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT02262117
Start Date
October 30 2015
End Date
April 1 2024
Last Update
January 29 2025
Active Locations (1)
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1
Hôpital Saint-Louis - Laboratoire MatriceLAb Innove
Paris, France, 75010