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