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

NCT05783349 | Completed

• 1 other identifier: 22-PP-17
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Repeated Implantation Failure (RIF); Embryo implantation; T cells activation

Outcome Measures

Primary Outcomes (1)

• Ex vivo comparison of the immune profile between patients with Repeated Implantation Failure and patients with successful implantation.

  The immune profiles are defined as the concentrations (in IU/mL or pg/mL) and ratios of proinflammatory and anti-inflammatory cytokines measured after nonspecific stimulation of peripheral blood cells from each patient: IFNγ, IL6, IL1β, TNFα, IL4, IL10, TGFβ, IFNγ/IL4, IFNγ/IL10, IFNγ/TGFβ, IL6/IL4, IL6/IL10, IL6/TGFβ, IL1β/IL4, IL1β/IL10, IL1β/TGFβ, TNFα/IL4, TNFα/IL10, TNFα/TGFβ.

  24 months

Secondary Outcomes (3)

• Ex vivo comparison of the immune profile between patients with one implantation failure and patients with successful implantation.

  24 months

• Ex vivo comparison of the immune profile between patients with one implantation failure in the context of inflammatory disorder (such as endometriosis) and patients with successful implantation.

  24 months

• Ex vivo comparison of the immune profile between patients with a pregnancy failure and patients with an active pregnancy at the end of the first trimester.

  24 months

Study Arms (1)

Women treated in the Medically Assisted Procreation (MAP) center of Nice

OTHER

Biological: Unique blod sample

Interventions

Unique blod sample BIOLOGICAL

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

Women treated in the Medically Assisted Procreation (MAP) center of Nice

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult women (aged 18 and above) treated in the Medically Assisted Procreation (MAP) center of the University Hospital of Nice, in the process of a frozen embryo transfer
• Social security affiliation
• Signed consent

You may not qualify if:

• Contra-indication to frozen embryo transfer
• Ongoing infection
• Patients under guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Chu de Nice

Nice, 06200, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 24, 2023
• Study Start: May 4, 2023
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)