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Predictive Value of Th1, Th2 and Th17 Cytokines on the Success of Embryo Implantation (ImmuNoFertilité)

NCT05783349 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2024-11-18

No results posted yet for this study

Summary

Infertility affects approximately 10-15% of the population. The number of assisted reproduction procedures has increased by a factor of 3 to 5.3 worldwide over the last 20 years. Despite recent techniques, pregnancy rates seem to be limited to 35% by embryo transfer. Embryo implantation depends on two factors: the quality of the embryo and the endometrial receptivity. Although good quality embryos are transferred, implantation may not occur. Changes in the maternal cytokine profile at the time of implantation may result in poor implantation or early abortions. Consequently, a misdirection of the immunological profile could be responsible for repeated implantation failure (RIF). The definition of RIF is not consensual, but most commonly refers to 3 failures after good quality embryo transfer, and would affect between 5 and 10% of patients.

The possibility of defining a predictive immune profile for RIF from a peripheral blood sample is debated. However, after stimulation of immune cells in peripheral blood, patients with RIF show an excessive pro-inflammatory profile.

Our objective is to assess the activation of T cells and innate immune cells (via an anti-CD3 agonist and a TLR7-8 ligand, respectively) from a blood sample to predict implantation success after frozen embryo transfer. This functional test is easy to use and applicable in a clinical routine.

Conditions

  • Assisted Reproduction

Interventions

BIOLOGICAL

Unique blod sample

sampling of 4mL of blood on lithium heparin tube, the day of frozen embryo implantation

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2024-02-23
Completion
2024-02-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05783349 on ClinicalTrials.gov