Low TGF-β and Embryo Implantation in the Context of Assisted Reproductive Technology: Confirmation of a Biomarker Predictive of Success and Characterization of the Immune Microenvironment.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

Infertility affects about one in seven couples in France. Beyond the medical and personal challenges, it has major societal implications. In vitro fertilization (IVF) offers hope to these couples, but success rates remain modest (about 30% per embryo transfer). The failure of embryo implantation is multifactorial. Among the factors involved, immune status at the time of embryo transfer plays a central role. Embryo transfer induces an acute pro-inflammatory immune response, and inadequate regulation of this response could compromise implantation.

We have previously identified a promising immune biomarker: TGF-β (Transforming Growth Factor Beta). In a prospective cohort of 255 patients undergoing frozen embryo transfer, we demonstrated that low circulating levels of TGF-β following nonspecific stimulation of immune cells on the day of embryo transfer were associated with a significant increase in the likelihood of implantation and live birth.

These results now require independent validation in a new cohort to establish their robustness and explore potential clinical applications. We hypothesize that measuring TGF-β concentration following stimulation can predict the success of embryo implantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult women,

Undergoing IVF treatment at the Nice University Hospital for frozen embryo transfer following a semi-natural or stimulated cycle,

Enrolled in the social security system,

No objection to participating in the study.

Disqualifiers

Any contraindication to frozen embryo transfer

Patients receiving donated gametes during this embryo transfer attempt

Current infectious disease

Patients protected by law who are under guardianship or conservatorship, or who are ineligible to participate in a clinical trial pursuant to Article L. 1121-16 of the French Public Health Code;

Trial population

Infertile woman

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Low circulating levels of TGF-β

To conduct an exploratory validation, in an independent cohort, of the association between low circulating levels of TGF-β-following nonspecific cellular stimulation at the time of frozen embryo transfer (after a semi-natural or stimulated cycle)-and an increased likelihood of embryo implantation. Embryo implantation will be confirmed by the visualization of an intrauterine gestational sac on an ultrasound performed during the first trimester following embryo transfer.

Time frame
24 months

Secondary outcomes

1

Association between TGF-β and the number of live births.

Confirm the association between low levels of stimulated TGF-β and the number of live births by noting the final outcome of the pregnancy: live birth or stillbirth.

Time frame
24 months
2

Circulating lymphocyte populations

Study circulating lymphocyte populations and their functional profile (intracellular cytokines) by flow cytometry, measuring cytokine levels (IL-1R, IL-2R, IL-6, IL-8, IL-10, IL-18, IFN-γ, TNF-α, IL-17A, IL-4, TGF-β, IL-12p70, IL-5 (in pg/ml)) found in cell supernatants following nonspecific stimulation (anti-CD3 agonist + TLR7/8 ligand), lymphocyte phenotyping (Th1, Th2, Treg, NK), and intracellular cytokine measurement by flow cytometry.

Time frame
24 months
3

Impact of exposure to air pollution

Assess the impact of exposure to air pollution on immune status and the success of embryo transfer by measuring average exposure to PM10, PM2.5, NO2, and O3 (in µg/m³) during the 6 months preceding embryo transfer.

Time frame
24 months

Other outcomes

Sponsors and contacts

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