Infertility (IVF Patients)NCT07085585
The Embryo-endometrium Multifaceted Interface: Endometrial Cavity Molecular Microbiobial and Transcriptomic Signatures in Predictinf Pregnancy Outcome in Infertile Patients Undergoing Assisted Reproduction Technology Procedures
An observational study of Infertility (IVF Patients), run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
In reproductive medicine, a fundamental challenge is to evaluate the endometrial health status during the embryo implantation window as a limiting step in predicting the success of treatments of assisted reproduction technology (ART). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility (IVF Patients)
- How many people
- 322 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jan 2021to 30 Nov 2025
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population is composed of women undergoing assisted reproduction treatments, specifically in vitro fertilization (IVF). These patients are followed in an outpatient setting at two specialized infertility centers in Italy: San Raffaele Hospital and Fondazione Cà Granda Policlinico. They are women who have been referred to IVF due to infertility, and are starting their first IVF cycle. All participants meet specific inclusion criteria, such as being between 18 and 39 years of age, having normal uterine anatomy, and no evidence of hydrosalpinx on ultrasound examination. The outpatient nature of the study allows for non-invasive sampling procedures and routine follow-up without the need for hospitalization. This setting reflects real-world clinical practice in reproductive medicine, ensuring that the findings will be directly applicable to standard IVF care. Additionally, the study includes a group of fertile women, also managed on an outpatient basis, who serve as a reference.
IVF Patients inclusion Criteria:
- Indication to ART
- Age 18-39 years
- First ART cycle
- Normal uterine morphology and no hydrosalpinx at ultrasound
IVF Patients exclusion Criteria:
- Poor responders according to Bologna criteria
- Indications to ART for severe male infertility
Fertile Patients inclusion Criteria:
- Subjects will be cycling women with proven fertility undergoing laparoscopy for tubal ligation
- BMI < 30
- Aged 20 to 40 years
Fertile Patients exclusion Criteria:
- Smokers
- Not taking any medication
Trial locations and contacts
1 site in 1 country.
Italy1 site
OSR Innate Immunity and tissue remodeling Unit and Centro Scienze Natalità OS
Milan, milano, 20133
About this study
In reproductive medicine, a fundamental challenge is to evaluate the endometrial health status during the embryo implantation window as a limiting step in predicting the success of treatments of assisted reproduction technology (ART). Some highthroughput tools, recently developed by private genomics companies, are available in the market even if they have not been independently validated and have different limitations. We propose a prospective cohort study with the aim of validating the reliability and increasing efficacy of these tools. Endometrial fluid samples will be collected non-invasively from women undergoing ART cycles and isolated genetic materials will be subjected to 16S rRNA gene sequencing for microbiota profiling and to RNAseq analysis of RNA content of extracellular vesicles previously recognized as a tissue proxy in predicting endometrial receptivity. Clinical pregnancy rate/first cycle will be the target outcome used to assess the resulting predictive models. Ultrasonographic features of the endometrium will also be collected and accounted for in the predictive model.
- Conditions
- Infertility (IVF Patients)
- Keywords
- Extracellular Vesicles, endometrial microbiome, RNA-Seq
- Medical subject headings
- Infertility
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 |
|---|---|---|
| fertile women | Reference group | |
| infertile women undergoing ART cycles | Cases group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of endometrial microbiome diversity
Evaluation of the endometrial microbiome composition and diversity using 16S rRNA sequencing to assess the functional impact of the endometrial microbial community in predicting the clinical pregnancy rate in women undergoing ART cycles.
Measured: through study completion, an average of 1 year
Extracellular Vesicle (EV) RNA Profiles
Quantification of extracellular vesicle (EV) RNA expression profiles from uterine fluid samples using RNA sequencing (expressed in CPM). Confirmation of the good correlation between expression of genes in tissue samples and in endometrial-derived EVs.
Measured: through study completion, an average of 1 year
Integrated Predictive Model for Clinical Pregnancy
Development of a multivariable predictive model combining endometrial microbiome diversity, EV RNA profiles, and ultrasound-AI analysis to predict clinical pregnancy rates in ART cycles.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start24 Jan 2021
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rovere Querini Patrizia, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085585
- Sponsor's protocol ID
- RF-2019-12369460
- Other IDs
- RF-2019-12369460
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Embryo-endometrium Multifaceted Interface: Endometrial Cavity Molecular Microbiobial and Transcriptomic Signatures in Predictinf Pregnancy Outcome in Infertile Patients Undergoing Assisted Reproduction Technology Procedures
- ClinicalTrials.gov ID
- NCT07085585
- Acronym / sponsor ID
- RF-2019-12369460
- Conditions
- Infertility (IVF Patients)
- Keywords
- Extracellular Vesicles, endometrial microbiome, RNA-Seq
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study start
- 24 Jan 2021 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 25 Jul 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.
In reproductive medicine, a fundamental challenge is to evaluate the endometrial health status during the embryo implantation window as a limiting step in predicting the success of treatments of assisted reproduction technology (ART). Some highthroughput tools, recently developed by private genomics companies, are available in the market even if they have not been independently validated and have different limitations. We propose a prospective cohort study with the aim of validating the reliability and increasing efficacy of these tools. Endometrial fluid samples will be collected non-invasively from women undergoing ART cycles and isolated genetic materials will be subjected to 16S rRNA gene sequencing for microbiota profiling and to RNAseq analysis of RNA content of extracellular vesicles previously recognized as a tissue proxy in predicting endometrial receptivity. Clinical pregnancy rate/first cycle will be the target outcome used to assess the resulting predictive models. Ultrasonographic features of the endometrium will also be collected and accounted for in the predictive model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fertile women | – | –Reference group |
| infertile women undergoing ART cycles | – | –Cases group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population is composed of women undergoing assisted reproduction treatments, specifically in vitro fertilization (IVF). These patients are followed in an outpatient setting at two specialized infertility centers in Italy: San Raffaele Hospital and Fondazione Cà Granda Policlinico. They are women who have been referred to IVF due to infertility, and are starting their first IVF cycle. All participants meet specific inclusion criteria, such as being between 18 and 39 years of age, having normal uterine anatomy, and no evidence of hydrosalpinx on ultrasound examination. The outpatient nature of the study allows for non-invasive sampling procedures and routine follow-up without the need for hospitalization. This setting reflects real-world clinical practice in reproductive medicine, ensuring that the findings will be directly applicable to standard IVF care. Additionally, the study includes a group of fertile women, also managed on an outpatient basis, who serve as a reference.
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
Identification of endometrial microbiome diversity
Time frame: through study completion, an average of 1 year
Evaluation of the endometrial microbiome composition and diversity using 16S rRNA sequencing to assess the functional impact of the endometrial microbial community in predicting the clinical pregnancy rate in women undergoing ART cycles.
Extracellular Vesicle (EV) RNA Profiles
Time frame: through study completion, an average of 1 year
Quantification of extracellular vesicle (EV) RNA expression profiles from uterine fluid samples using RNA sequencing (expressed in CPM). Confirmation of the good correlation between expression of genes in tissue samples and in endometrial-derived EVs.
Integrated Predictive Model for Clinical Pregnancy
Time frame: through study completion, an average of 1 year
Development of a multivariable predictive model combining endometrial microbiome diversity, EV RNA profiles, and ultrasound-AI analysis to predict clinical pregnancy rates in ART cycles.
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 25 Jul 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (IVF Patients), run by IRCCS San Raffaele 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?
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: under way, not looking for participants, as of the sponsor's last update on 25 Jul 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?
Identification of endometrial microbiome diversity (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2025.