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Enrolling by Invitation

NCT Number: NCT07120958

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

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

Enrolling by Invitation

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Key information

Age range

20 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

MOMO' Fertilife

Bisceglie, BT, 76011, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Characterise the molecular immunologic mechanism underlying embryo implantation

    Time frame: from 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 outcomes

  1. to study the possible correlations of the expression of the interleukins involved in the implantation process of the embryo

    Time frame: The endometrial biopsy on which the interleukin dosage will be done, will be taken one month before the embryo transfer

    to 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 outcomes

  1. to assess whether progesterone levels can alter the immune response

    Time frame: the same day of the embryo transfer

    immunofluorescence device; unit of measure: ng/ml

Sponsors and collaborators

Lead sponsor

Momo Fertilife

Other

Collaborators

  • IRCCS Casa Sollievo della Sofferenza
  • University of Bari
  • University of Florence

Registry information

Official study title

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

Acronym: UTIMEE

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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