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

NCT ID: NCT02262117

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-30
• Study Completion Date: 2024-04-30

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard care

No specific treatment (standard care)

Group Type: PLACEBO_COMPARATOR

standard care

Intervention Type: OTHER

No specific medical care

specific treatment

As a deregulation has been diagnosed by immune analysis, a personalization of the medical care for this IVF/ICSI attempt will be dispensed Personalization of treatment should follow a step-to step decision tree.

Group Type: EXPERIMENTAL

specific treatment

Intervention Type: DRUG

Regarding the immune endometrial profiling, medical care (personalization of treatment) should follow a step by step decision tree.

Interventions

standard care

No specific medical care

Intervention Type: OTHER

specific treatment

Regarding the immune endometrial profiling, medical care (personalization of treatment) should follow a step by step decision tree.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie LEDEE, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Saint-Louis - Laboratoire MatriceLAb Innove

Paris, , France

Countries

France

References

Ledee N, Petitbarat M, Dray G, Chevrier L, Kazhalawi A, Rahmati M, Vicaut E, Diallo A, Cassuto NG, Ruoso L, Prat-Ellenberg L. Endometrial immune profiling and precision therapy increase live birth rate after embryo transfer: a randomised controlled trial. Front Immunol. 2025 Feb 24;16:1523871. doi: 10.3389/fimmu.2025.1523871. eCollection 2025.

Reference Type: DERIVED

PMID: 40066441 (View on PubMed)

Other Identifiers

P130929

Identifier Type: -

Identifier Source: org_study_id