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Clinical Trials in France / NCT07859930
Starting soon Observational

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.

NCT07859930 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Nice
Phase
Observational
Started
2026-11
Last updated
2026-10-06

Condition(s) studied

Infertility, FemalePregnancy Related

Study summary

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adult women, 2. Undergoing IVF treatment at the Nice University Hospital for frozen embryo transfer following a semi-natural or stimulated cycle, 3. Enrolled in the social security system, 4. No objection to participating in the study. Exclusion Criteria: 1. Any contraindication to frozen embryo transfer 2. Patients receiving donated gametes during this embryo transfer attempt 3. Current infectious disease 4. 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; 5. Patients subject to a judicial protective measure.

Primary outcome measure(s)

  • Low circulating levels of TGF-β — 24 months
    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.

Trial sites (1)

FacilityCityRegionStatus
CHU Nice - Hôpital de l'Archet 2 Nice Alpes-Mritimes

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07859930 on ClinicalTrials.gov ↗ ← All trials in France