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

Assisted Reproduction Clinical Trial

Official title:

To Study the Predictive Value of Th1, Th2 and Th17 Cytokine Serum Levels Produced After Non-specific Stimulation on the Success of Embryo Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783349
• Other study ID #: 22-PP-17
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: February 2025

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Pierre-Alexis GAUCI, MD
• Phone: +33492036092
• Email: gauci.pa[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Contra-indication to frozen embryo transfer

• Ongoing infection

• Patients under guardianship

Related Conditions & MeSH terms

• Assisted Reproduction

Intervention

Biological:
• Unique blod sample
sampling of 4mL of blood on lithium heparin tube, the day of frozen embryo implantation

Locations

Country	Name	City	State
France	Chu de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: IFN?, IL6, IL1ß, TNFa, IL4, IL10, TGFß, IFN?/IL4, IFN?/IL10, IFN?/TGFß, IL6/IL4, IL6/IL10, IL6/TGFß, IL1ß/IL4, IL1ß/IL10, IL1ß/TGFß, TNFa/IL4, TNFa/IL10, TNFa/TGFß.	24 months
Secondary	Ex vivo comparison of the immune profile between patients with one 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: IFN?, IL6, IL1ß, TNFa, IL4, IL10, TGFß, IFN?/IL4, IFN?/IL10, IFN?/TGFß, IL6/IL4, IL6/IL10, IL6/TGFß, IL1ß/IL4, IL1ß/IL10, IL1ß/TGFß, TNFa/IL4, TNFa/IL10, TNFa/TGFß.	24 months
Secondary	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.	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: IFN?, IL6, IL1ß, TNFa, IL4, IL10, TGFß, IFN?/IL4, IFN?/IL10, IFN?/TGFß, IL6/IL4, IL6/IL10, IL6/TGFß, IL1ß/IL4, IL1ß/IL10, IL1ß/TGFß, TNFa/IL4, TNFa/IL10, TNFa/TGFß.	24 months
Secondary	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.	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: IFN?, IL6, IL1ß, TNFa, IL4, IL10, TGFß, IFN?/IL4, IFN?/IL10, IFN?/TGFß, IL6/IL4, IL6/IL10, IL6/TGFß, IL1ß/IL4, IL1ß/IL10, IL1ß/TGFß, TNFa/IL4, TNFa/IL10, TNFa/TGFß.; Pregnancy test: ßhCG concentration on blood sample in IU/L. Result of the ultrasound performed routinely during the first trimester (between 4 and 11 amenorrhea weeks): presence or absence of intrauterine pregnancy , progressive or not.	24 months