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The Impact of Uterine Immunity and Its Alterations on the Embryo Implantation Process

What Impact Does Uterine Immunity Have on the Success of Euploid Thawed Embryos?

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07120958
Acronym
UTIMEE
Enrollment
30
Registered
2025-08-13
Start date
2025-05-01
Completion date
2026-07-01
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility Assisted Reproductive Technology

Keywords

interleukin, ngs, art, icsi, implantation, euploid, uterine immunity

Brief summary

Evaluation of uterine immunity, histological picture, and endometrial microbiome for embryo implantation

Interventions

None listed

Sponsors

University of Bari
CollaboratorOTHER
University of Florence
CollaboratorOTHER
Casa Sollievo della Sofferenza-IRCCS, San Giovanni Rotondo
CollaboratorUNKNOWN
Momo Fertilife
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 42 Years
Healthy volunteers
Yes

Inclusion criteria

Female patients aged \>18 and \<43 years at the time of embryo transfer. Transfer of cryopreserved embryos diagnosed as euploid through preimplantation genetic testing for aneuploidy (PGT-A). Embryo transfer performed at the blastocyst stage.

Exclusion criteria

Patients with an intrauterine device (IUD) in situ within the three months prior to study enrollment. Presence of autoimmune diseases and/or ongoing treatment with corticosteroids. Structural or pathological abnormalities of the uterine cavity, including but not limited to polyps, intramural myomas measuring 2-4 cm, submucosal fibroids, uterine septum, or hydrosalpinx, identified during study participation. Patients with a history of these conditions may be included if the pathology has been resolved prior to the initiation of any study-related procedures or sample collection. Presence of severe or uncontrolled fungal or viral infections which, in the opinion of the principal investigator, may compromise the patient's ability to participate or affect the integrity of study outcomes. Any medical condition or illness that is unstable, poses a potential risk to patient safety, or may interfere with adherence to the study protocol. Patients lacking a confirmed preimplantation genetic diagnosis of euploidy. Patients with a clinical diagnosis of endometriosis or adenomyosis.

Design outcomes

Primary

MeasureTime frameDescription
Characterise the molecular immunologic mechanism underlying embryo implantationfrom enrollment to the pregnancy test (12 days after embryo transfer)The main objective of this research is to characterise the molecular immunologic mechanism underlying embryo implantation. These outcomes will be assessed regarding the percentage of expressivity of some interleukins in pregnant couples and those who are not

Secondary

MeasureTime frameDescription
to study the possible correlations of the expression of the interleukins involved in the implantation process of the embryoThe endometrial biopsy on which the interleukin dosage will be done, will be taken one month before the embryo transferto study the possible correlations of the expression of the interleukins involved with related anatomical and histological pictures. Interleukin dosage will be assessed through PCR. The unit of measure is ng/ml.

Other

MeasureTime frameDescription
to assess whether progesterone levels can alter the immune responsethe same day of the embryo transferimmunofluorescence device; unit of measure: ng/ml

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026