Infertility Assisted Reproductive TechnologyUTIMEENCT07120958
The Impact of Uterine Immunity and Its Alterations on the Embryo Implantation Process
An observational study of Infertility Assisted Reproductive Technology, run by Momo Fertilife at 1 site in Italy.
Trial summary
Evaluation of uterine immunity, histological picture, and endometrial microbiome for embryo implantation Read more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility Assisted Reproductive Technology
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who undertake ART treatment in South Italy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: What Impact Does Uterine Immunity Have on the Success of Euploid Thawed Embryos?
Evaluation of uterine immunity, histological picture, and endometrial microbiome for embryo implantation
- Keywords
- interleukin, ngs, art, icsi, implantation, euploid, uterine immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| endometrial biopsy with pregnancy | Not described | |
| endometrial biopsy without pregancy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterise the molecular immunologic mechanism underlying embryo implantation
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
Measured: from enrollment to the pregnancy test (12 days after embryo transfer)
Secondary outcomes (1)
to study the possible correlations of the expression of the interleukins involved in the implantation process of the embryo
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.
Measured: The endometrial biopsy on which the interleukin dosage will be done, will be taken one month before the embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 May 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Infertility Assisted Reproductive TechnologyStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Momo Fertilife
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari, University of Florence, IRCCS Casa Sollievo della Sofferenza
- Responsible party
- Principal investigator, Daniele Ferri, Momo Fertilife
- Investigators
- Domenico Baldini, Degree in Medicine and Surgery, Principal investigator, Momo Fertilife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120958
- Sponsor's protocol ID
- 32/cf/2025
- Acronym
- UTIMEE
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagaeva O, Jonsson L, Mincheva-Nilsson L. Dominant IL-10 and TGF-beta mRNA expression in gammadeltaT cells of human early pregnancy decidua suggests immunoregulatory potential. Am J Reprod Immunol. 2002 Jul;48(1):9-17. doi: 10.1034/j.1600-0897.2002.01131.x.
PubMed 12322898Vitoratos N, Papadias C, Economou E, Makrakis E, Panoulis C, Creatsas G. Elevated circulating IL-1beta and TNF-alpha, and unaltered IL-6 in first-trimester pregnancies complicated by threatened abortion with an adverse outcome. Mediators Inflamm. 2006;2006(4):30485. doi: 10.1155/MI/2006/30485.
PubMed 17047289Lombardelli L, Logiodice F, Kullolli O, Haller H, Agostinis C, Bulla R, Rukavina D, Piccinni MP. At Embryo Implantation Site IL-35 Secreted by Trophoblast, Polarizing T Cells towards IL-35+ IL-10+ IL-4+ Th2-Type Cells, Could Favour Fetal Allograft Tolerance and Pregnancy Success. Int J Mol Sci. 2022 Apr 28;23(9):4926. doi: 10.3390/ijms23094926.
PubMed 35563316Ledee N, Petitbarat M, Prat-Ellenberg L, Dray G, Cassuto GN, Chevrier L, Kazhalawi A, Vezmar K, Chaouat G. The uterine immune profile: A method for individualizing the management of women who have failed to implant an embryo after IVF/ICSI. J Reprod Immunol. 2020 Nov;142:103207. doi: 10.1016/j.jri.2020.103207. Epub 2020 Sep 14.
PubMed 32971456Szekeres-Bartho J. The Role of Progesterone in Feto-Maternal Immunological Cross Talk. Med Princ Pract. 2018;27(4):301-307. doi: 10.1159/000491576. Epub 2018 Jun 27.
PubMed 29949797Piccinni MP, Raghupathy R, Saito S, Szekeres-Bartho J. Cytokines, Hormones and Cellular Regulatory Mechanisms Favoring Successful Reproduction. Front Immunol. 2021 Jul 28;12:717808. doi: 10.3389/fimmu.2021.717808. eCollection 2021.
PubMed 34394125Mahajan D, Kumar T, Rath PK, Sahoo AK, Mishra BP, Kumar S, Nayak NR, Jena MK. Dendritic Cells and the Establishment of Fetomaternal Tolerance for Successful Human Pregnancy. Arch Immunol Ther Exp (Warsz). 2024 May 23;72(1). doi: 10.2478/aite-2024-0010. eCollection 2024 Jan 1.
PubMed 38782369Zhou J, Yan P, Ma W, Li J. Cytokine modulation and immunoregulation of uterine NK cells in pregnancy disorders. Cytokine Growth Factor Rev. 2025 Feb;81:40-53. doi: 10.1016/j.cytogfr.2024.11.007. Epub 2024 Nov 23.
PubMed 39603954Parasar P, Guru N, Nayak NR. Contribution of macrophages to fetomaternal immunological tolerance. Hum Immunol. 2021 May;82(5):325-331. doi: 10.1016/j.humimm.2021.02.013. Epub 2021 Mar 11.
PubMed 33715911Wang W, Sung N, Gilman-Sachs A, Kwak-Kim J. T Helper (Th) Cell Profiles in Pregnancy and Recurrent Pregnancy Losses: Th1/Th2/Th9/Th17/Th22/Tfh Cells. Front Immunol. 2020 Aug 18;11:2025. doi: 10.3389/fimmu.2020.02025. eCollection 2020.
PubMed 32973809Szekeres-Bartho J. Immunological relationship between the mother and the fetus. Int Rev Immunol. 2002 Nov-Dec;21(6):471-95. doi: 10.1080/08830180215017.
PubMed 12650238Abu-Raya B, Michalski C, Sadarangani M, Lavoie PM. Maternal Immunological Adaptation During Normal Pregnancy. Front Immunol. 2020 Oct 7;11:575197. doi: 10.3389/fimmu.2020.575197. eCollection 2020.
PubMed 33133091
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Impact Does Uterine Immunity Have on the Success of Euploid Thawed Embryos?
- ClinicalTrials.gov ID
- NCT07120958
- Acronym / sponsor ID
- UTIMEE / 32/cf/2025
- Keywords
- interleukin, ngs, art, icsi, implantation, euploid, uterine immunity
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Momo FertilifeUniversity, hospital or other
- Collaborators
- University of Bari, University of Florence, IRCCS Casa Sollievo della Sofferenza
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of uterine immunity, histological picture, and endometrial microbiome for embryo implantation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endometrial biopsy with pregnancy | – | – |
| endometrial biopsy without pregancy | – | – |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who undertake ART treatment in South Italy
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 12322898Nagaeva O, Jonsson L, Mincheva-Nilsson L. Dominant IL-10 and TGF-beta mRNA expression in gammadeltaT cells of human early pregnancy decidua suggests immunoregulatory potential. Am J Reprod Immunol. 2002 Jul;48(1):9-17. doi: 10.1034/j.1600-0897.2002.01131.x.
- Background: PubMed 17047289Vitoratos N, Papadias C, Economou E, Makrakis E, Panoulis C, Creatsas G. Elevated circulating IL-1beta and TNF-alpha, and unaltered IL-6 in first-trimester pregnancies complicated by threatened abortion with an adverse outcome. Mediators Inflamm. 2006;2006(4):30485. doi: 10.1155/MI/2006/30485.
- Background: PubMed 35563316Lombardelli L, Logiodice F, Kullolli O, Haller H, Agostinis C, Bulla R, Rukavina D, Piccinni MP. At Embryo Implantation Site IL-35 Secreted by Trophoblast, Polarizing T Cells towards IL-35+ IL-10+ IL-4+ Th2-Type Cells, Could Favour Fetal Allograft Tolerance and Pregnancy Success. Int J Mol Sci. 2022 Apr 28;23(9):4926. doi: 10.3390/ijms23094926.
- Background: PubMed 32971456Ledee N, Petitbarat M, Prat-Ellenberg L, Dray G, Cassuto GN, Chevrier L, Kazhalawi A, Vezmar K, Chaouat G. The uterine immune profile: A method for individualizing the management of women who have failed to implant an embryo after IVF/ICSI. J Reprod Immunol. 2020 Nov;142:103207. doi: 10.1016/j.jri.2020.103207. Epub 2020 Sep 14.
- Background: PubMed 29949797Szekeres-Bartho J. The Role of Progesterone in Feto-Maternal Immunological Cross Talk. Med Princ Pract. 2018;27(4):301-307. doi: 10.1159/000491576. Epub 2018 Jun 27.
- Background: PubMed 34394125Piccinni MP, Raghupathy R, Saito S, Szekeres-Bartho J. Cytokines, Hormones and Cellular Regulatory Mechanisms Favoring Successful Reproduction. Front Immunol. 2021 Jul 28;12:717808. doi: 10.3389/fimmu.2021.717808. eCollection 2021.
- Background: PubMed 38782369Mahajan D, Kumar T, Rath PK, Sahoo AK, Mishra BP, Kumar S, Nayak NR, Jena MK. Dendritic Cells and the Establishment of Fetomaternal Tolerance for Successful Human Pregnancy. Arch Immunol Ther Exp (Warsz). 2024 May 23;72(1). doi: 10.2478/aite-2024-0010. eCollection 2024 Jan 1.
- Background: PubMed 39603954Zhou J, Yan P, Ma W, Li J. Cytokine modulation and immunoregulation of uterine NK cells in pregnancy disorders. Cytokine Growth Factor Rev. 2025 Feb;81:40-53. doi: 10.1016/j.cytogfr.2024.11.007. Epub 2024 Nov 23.
- Background: PubMed 33715911Parasar P, Guru N, Nayak NR. Contribution of macrophages to fetomaternal immunological tolerance. Hum Immunol. 2021 May;82(5):325-331. doi: 10.1016/j.humimm.2021.02.013. Epub 2021 Mar 11.
- Background: PubMed 32973809Wang W, Sung N, Gilman-Sachs A, Kwak-Kim J. T Helper (Th) Cell Profiles in Pregnancy and Recurrent Pregnancy Losses: Th1/Th2/Th9/Th17/Th22/Tfh Cells. Front Immunol. 2020 Aug 18;11:2025. doi: 10.3389/fimmu.2020.02025. eCollection 2020.
- Background: PubMed 12650238Szekeres-Bartho J. Immunological relationship between the mother and the fetus. Int Rev Immunol. 2002 Nov-Dec;21(6):471-95. doi: 10.1080/08830180215017.
- Background: PubMed 33133091Abu-Raya B, Michalski C, Sadarangani M, Lavoie PM. Maternal Immunological Adaptation During Normal Pregnancy. Front Immunol. 2020 Oct 7;11:575197. doi: 10.3389/fimmu.2020.575197. eCollection 2020.
- Individual participant dataSharing planned: No
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Infertility Assisted Reproductive Technology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Domenico Baldini, Degree in Medicine and Surgery principal investigator
Momo Fertilife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility Assisted Reproductive Technology, run by Momo Fertilife at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterise the molecular immunologic mechanism underlying embryo implantation (time frame: from enrollment to the pregnancy test (12 days after embryo transfer)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07120958, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.