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. (ImmuNoFertilit)
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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Pierre-Alexis GAUCI, MD-PHD
- Telefonnummer: +33 4 92 03 61 90
- E-post: gauci.pa@chu-nice.fr
Studiesteder
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Alpes-Mritimes
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Nice, Alpes-Mritimes, Frankrike, 06200
- CHU Nice - Hôpital de l'Archet 2
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Ta kontakt med:
- Pierre-Alexis GAUCI, MD-PHD
- Telefonnummer: +33 4 92 03 61 90
- E-post: gauci.pa@chu-nice.fr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Infertile woman
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Low circulating levels of TGF-β
Tidsramme: 24 months
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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. |
24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation between TGF-β and the number of live births.
Tidsramme: 24 months
|
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. |
24 months
|
|
Circulating lymphocyte populations
Tidsramme: 24 months
|
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. |
24 months
|
|
Impact of exposure to air pollution
Tidsramme: 24 months
|
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. |
24 months
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26-PP-14
Legemiddel- og utstyrsinformasjon, studiedokumenter
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