Infertility, FemaleImmuNoFertilitNCT07859930
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.
An observational study of Infertility, Female and Pregnancy Related, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility, Female, Pregnancy Related
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Nov 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Infertile woman
Who may be able to join
- 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.
Who cannot join
- 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;
- Patients subject to a judicial protective measure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes-Mritimes, 06200
Pierre-Alexis GAUCI, MD-PHD, 4 92 03 61 90 ext. +33, gauci.pa@chu-nice.fr
About this study
Official title: 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 - ImmuNoFertilité 2
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.
The investigators have previously identified a promising immune biomarker: TGF-β (Transforming Growth Factor Beta). In a prospective cohort of 255 patients undergoing frozen embryo transfer, the investigators 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. The investigators hypothesize that measuring TGF-β concentration following stimulation can predict the success of embryo implantation.
- Conditions
- Infertility, Female, Pregnancy Related
- Keywords
- infertility, pregnancy, TGF-β
- Medical subject headings
- Infertility, Female, Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (3)
Correlation between TGF-β and the number of live births.
Confirm the correlation 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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859930
- Sponsor's protocol ID
- 26-PP-14
- Acronym
- ImmuNoFertilit
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No