NCT02262117

Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates

A Prospective, Randomized, Controlled, Two-arm Study to Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates Through a Care Personalization in Reproductive Medicine Before IVF

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

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 patients treated are partially or totally concerned by problem of inadequate uterine receptivity. The investigators' hypothesis is that a pre-conceptional immune endometrial evaluation may increase significantly birth rates since successful implantation results from both the matching of a competent embryo within a competent endometrium. The identification of endometrial biomarkers documenting the immune uterine environment during the implantation window would be able to improve the efficacy of ART through a personalization of treatment accordingly to the ability of the patients to receive their embryos. All patients with all inclusion criteria and no exclusion criteria will be included. Only patients with a deregulation (immune analysis) will be randomized.

Conditions

• Reproductive Medicine

Interventions

Type	Name	Description
OTHER	standard care	No specific medical care
DRUG	specific treatment	Regarding the immune endometrial profiling, medical care (personalization of treatment) should follow a step by step decision tree.

Timeline

• Start date: 2015-10-30
• Primary completion: 2024-03-22
• Completion: 2024-04-01
• First posted: 2014-10-10
• Last updated: 2025-01-29

Locations

1 site across 1 country: France