Female InfertilityFIB_CARIPLONCT06098495
Looking for a Blood Epigenetic Signature to Predict Female Infertility
An observational study of Female Infertility, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
The present research project aims to study the DNAm mechanisms underlying the reduction of fertility due to the progressive depletion of oocyte quality. Specifically, our project aims to build an epigenetic clock for MGCs by using outcomes that are certainly related to female fertility. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Infertility
- What is being tested?
- search for epigenetic profile of infertility
- How many people
- 1,456 participants
- Where
- 1 siteItaly
- Study dates
- 16 Oct 2023to 16 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Infertile woman undergoing ART, women affected by recurrent pregnancy loss, women attempting to conceive naturally
Who may be able to join
- 18< age <43, Infertile woman undergoing ART, recurrent pregnancy loss
Who cannot join
- age < 18 or > 44, previous ovarian surgery, severe male factor infertility
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Università Vita Salute San Raffaele
Milan
Valeria Stella Vanni, +393476309895, vanni.valeria@hsr.it
Sara D'Alessandro
About this study
The present research project aims to study the DNAm mechanisms underlying the reduction of fertility due to the progressive depletion of oocyte quality. Specifically, our project aims to build an epigenetic clock for MGCs by using outcomes that are certainly related to female fertility. The validation of such findings will be carried out on peripheral blood in order to guarantee its non-invasiveness and allow for any clinical transferability. In order to identify a blood epigenetic signature able to predict female infertility, we planned to explore the problem from different points of view by conducting several studies in different settings.
- Conditions
- Female Infertility
- Being tested
- search for epigenetic profile of infertility
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
search for epigenetic profile of infertilityGenetic
examine the epigenetic profile of DNA extracted from MGCs and blood sample
| Study group | Role | What they receive |
|---|---|---|
| infertile women (unexplained, tubal, mild male factor) | women belonging to couples selected for homologous IVF due to an unexplained, tubal or mild male factor | |
| fertile women | women without any infertility history who are attempting to conceive naturally Receives: Genetic: search for epigenetic profile of infertility | |
| infertile women (ovarian factor) | women selected for homologous IVF for different reason og chohort 1 Receives: Genetic: search for epigenetic profile of infertility | |
| recurrent pregnancy loss | women affected by idiopathic recurrent pregnancy loss Receives: Genetic: search for epigenetic profile of infertility |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences of DNA methylation in granulosa cells of patients undergoing ART
The epigenetic profile of DNA extracted from granulosa cells of patients undergoing ART (COHORT1) will be examined to identify position and region's differences of DNA methylation in pregnant women (fertile women) and in who does not get pregnant (infertile women)
Measured: 3 years
differences of DNA methylationin the peripheral venous blood of patients undergoing ART
search for this methylation difference found in the granulosa cell sample, also in the peripheral venous blood of these same patients
Measured: 3 years
differences of DNA methylationin the peripheral venous blood of women attempting to conceive naturally
The specific epigenetic modification will be searched in the peripheral venous blood of women attempting to conceive naturally (COHORT2)
Measured: 3 years
differences of DNA methylationin the peripheral venous blood of new patients undergoing ART
The specific epigenetic modification will be searched in the peripheral venous blood of two new cohorts of patients referred to PMA centres.
Measured: 3 years
impact of exogenous pro-inflammatory factors
on all the above cohorts will be investigated, via online questionnaire
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start16 Oct 2023
- Primary completion16 Oct 2026 (estimated)
- Study completion16 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies 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
- 1,456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeria Stella Vanni, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098495
- Sponsor's protocol ID
- FIB_CARIPLO_1.0
- Acronym
- FIB_CARIPLO
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: publication of the results at the end of the trial
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Looking for a Blood Epigenetic Signature to Predict Female Infertility
- ClinicalTrials.gov ID
- NCT06098495
- Acronym / sponsor ID
- FIB_CARIPLO / FIB_CARIPLO_1.0
- Conditions
- Female Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,456 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 16 Oct 2026 (estimated)
- First posted
- 24 Oct 2023 (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.
The present research project aims to study the DNAm mechanisms underlying the reduction of fertility due to the progressive depletion of oocyte quality. Specifically, our project aims to build an epigenetic clock for MGCs by using outcomes that are certainly related to female fertility. The validation of such findings will be carried out on peripheral blood in order to guarantee its non-invasiveness and allow for any clinical transferability. In order to identify a blood epigenetic signature able to predict female infertility, we planned to explore the problem from different points of view by conducting several studies in different settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| infertile women (unexplained, tubal, mild male factor) | – | –women belonging to couples selected for homologous IVF due to an unexplained, tubal or mild male factor |
| fertile women | – | Genetic: search for epigenetic profile of infertilitywomen without any infertility history who are attempting to conceive naturally |
| infertile women (ovarian factor) | – | Genetic: search for epigenetic profile of infertilitywomen selected for homologous IVF for different reason og chohort 1 |
| recurrent pregnancy loss | – | Genetic: search for epigenetic profile of infertilitywomen affected by idiopathic recurrent pregnancy loss |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Infertile woman undergoing ART, women affected by recurrent pregnancy loss, women attempting to conceive naturally
Key inclusion criteria (1 listed)
- 18< age <43, Infertile woman undergoing ART, recurrent pregnancy loss
Key exclusion criteria (1 listed)
- age < 18 or > 44, previous ovarian surgery, severe male factor infertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| search for epigenetic profile of infertilityexamine the epigenetic profile of DNA extracted from MGCs and blood sample | Genetic | fertile women, infertile women (ovarian factor), recurrent pregnancy loss |
Primary outcome
differences of DNA methylation in granulosa cells of patients undergoing ART
Time frame: 3 years
The epigenetic profile of DNA extracted from granulosa cells of patients undergoing ART (COHORT1) will be examined to identify position and region's differences of DNA methylation in pregnant women (fertile women) and in who does not get pregnant (infertile women)
differences of DNA methylationin the peripheral venous blood of patients undergoing ART
Time frame: 3 years
search for this methylation difference found in the granulosa cell sample, also in the peripheral venous blood of these same patients
differences of DNA methylationin the peripheral venous blood of women attempting to conceive naturally
Time frame: 3 years
The specific epigenetic modification will be searched in the peripheral venous blood of women attempting to conceive naturally (COHORT2)
differences of DNA methylationin the peripheral venous blood of new patients undergoing ART
Time frame: 3 years
The specific epigenetic modification will be searched in the peripheral venous blood of two new cohorts of patients referred to PMA centres.
impact of exogenous pro-inflammatory factors
Time frame: 3 years
on all the above cohorts will be investigated, via online questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No. publication of the results at the end of the trial
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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.
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 Female Infertility, run by Università Vita-Salute 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?
The sponsor lists 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valeria Stella Vanni (+393476309895, vanni.valeria@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences of DNA methylation in granulosa cells of patients undergoing ART (time frame: 3 years). The study lists 5 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 24 Oct 2023.