Infertility Assisted Reproductive TechnologyARTCLOCKNCT07875140
Epigenetic Clock to Predict Ovarian Aging and Live Birth in ART
An observational study of Infertility Assisted Reproductive Technology and Ovarian Aging, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Epigenetic clocks based on DNA methylation estimate biological age and are associated with age-related conditions, but they have not been validated for female fertility. This prospective, multicenter, observational, non-profit cohort study investigated whether epigenetic age, estimated from peripheral blood DNA… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility Assisted Reproductive Technology, Ovarian Aging
- What is being tested?
- Peripheral blood sampling for epigenetic age estimation
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2025to 20 Apr 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women undergoing IVF or ICSI at two Italian assisted reproduction centers.
Who may be able to join
- Age 18 years or older
- Indication for IVF or ICSI
- FSH levels below 15 IU/mL
- Signed informed consent
Who cannot join
- Uterine abnormalities (fibroids, adenomyosis, endometrial polyps, uterine septum)
- Hydrosalpinx diagnosed on baseline ultrasound
- Severe male factor infertility (azoospermia with surgical sperm retrieval, cryptozoospermia, necrozoospermia)
- Systemic diseases that may negatively affect pregnancy and cause miscarriage (e.g., diabetes, uncompensated thyroid disease, antiphospholipid syndrome)
- Additional blood sampling subgroup: the first 30 enrolled women under 40 years of age who agreed to participate through a specific consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Epigenetic Clocks to Predict Ovarian Aging and Live Birth Rate in Assisted Reproduction Technology Procedures
Epigenetic clocks based on DNA methylation estimate biological age and are associated with age-related conditions, but they have not been validated for female fertility. This prospective, multicenter, observational, non-profit cohort study investigated whether epigenetic age, estimated from peripheral blood DNA methylation, differs between women undergoing in vitro fertilization (IVF/ICSI) who achieve a live birth and those who do not. In a predefined subgroup of 30 women under 40 years of age, epigenetic age was also assessed after ovarian stimulation. Participation did not change clinical management.
Read the detailed description
Women undergoing IVF or ICSI were recruited at the pre-admission visit at two Italian assisted reproduction centers: the coordinating center (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan) and a collaborating center (Policlinico Umberto I, Rome). During routine blood draws an additional blood aliquot (about 5 ml) was collected and stored at -80°C. DNA was extracted from leukocytes and analyzed with the Illumina EPIC methylation array. Epigenetic age was estimated with different epigenetic clocks.
Clinical data were extracted from medical records. Women who became pregnant were contacted by phone after the expected date of delivery to collect pregnancy and delivery data. Pregnancy follow-up was also collected from routine clinical records.
In a predefined subgroup of the first 30 enrolled women under 40 years of age, a second blood sample was collected after ovarian stimulation, on the day of oocyte retrieval, in order to compare epigenetic age before and after stimulation.
The primary analysis was a logistic regression of live birth on epigenetic age, with multivariable adjustment for potential confounders such as chronological age, BMI, male age, leukocyte composition, smoking status and ovarian reserve. The planned sample size of 400 women (about 120 pregnancies) was based on a 1.2-year difference in biological age observed in a previous pilot study. Sensitivity analyses excluded women with spontaneous conception, treatment discontinuation, or cycles not reaching oocyte retrieval.
- Being tested
- Peripheral blood sampling for epigenetic age estimation
- Keywords
- epigenetic clock, DNA methylation, biological age, epigenetic age acceleration, in vitro fertilization, live birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood sampling for epigenetic age estimationOther
Collection of an additional blood aliquot (about 5 ml) during routine blood draws; DNA extracted from leukocytes and analyzed with the Illumina EPIC methylation array to estimate epigenetic age. No additional visits or procedures beyond routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing IVF/ICSI | Adult women with an indication for IVF or ICSI, followed through their assisted reproduction cycle and pregnancy outcome. An additional blood aliquot (about 5 ml) was collected during routine blood draws at the pre-admission visit. In a predefined subgroup of the first 30 women under 40 years of age, a second blood sample was collected after ovarian stimulation, on the day of oocyte retrieval. Receives: Other: Peripheral blood sampling for epigenetic age estimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic age in women with and without live birth after IVF/ICSI
Epigenetic (biological) age estimated from DNA methylation of peripheral blood leukocytes (Illumina EPIC array), compared between women who achieved a live birth and women who did not.
Measured: From enrollment (pre-admission visit) to delivery of the pregnancy resulting from the ART cycle (approximately 12 months)
Secondary outcomes (1)
Change in epigenetic age after ovarian stimulation
Epigenetic age estimated from peripheral blood DNA methylation before and after ovarian stimulation, compared in a predefined subgroup of 30 women under 40 years of age.
Measured: From enrollment (pre-admission visit) to the day of oocyte retrieval in the same ART cycle, assessed up to approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start6 Mar 2025
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- 400 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Policlinico Umberto I Roma, University of Milan
- Responsible party
- Sponsor
- Investigators
- Edgardo Somigliana, PhD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875140
- Sponsor's protocol ID
- PMA2024_08
- Other IDs
- 2022R3LS5B
- Acronym
- ARTCLOCK
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Study results will be published in aggregated or anonymized form, so that participants cannot be identified.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Epigenetic Clocks to Predict Ovarian Aging and Live Birth Rate in Assisted Reproduction Technology Procedures
- ClinicalTrials.gov ID
- NCT07875140
- Acronym / sponsor ID
- ARTCLOCK / PMA2024_08
- Keywords
- epigenetic clock, DNA methylation, biological age, epigenetic age acceleration, in vitro fertilization, live birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Policlinico Umberto I Roma, University of Milan
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 15 Oct 2026 (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.
Epigenetic clocks based on DNA methylation estimate biological age and are associated with age-related conditions, but they have not been validated for female fertility. This prospective, multicenter, observational, non-profit cohort study investigated whether epigenetic age, estimated from peripheral blood DNA methylation, differs between women undergoing in vitro fertilization (IVF/ICSI) who achieve a live birth and those who do not. In a predefined subgroup of 30 women under 40 years of age, epigenetic age was also assessed after ovarian stimulation. Participation did not change clinical management.
Detailed description
Women undergoing IVF or ICSI were recruited at the pre-admission visit at two Italian assisted reproduction centers: the coordinating center (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan) and a collaborating center (Policlinico Umberto I, Rome). During routine blood draws an additional blood aliquot (about 5 ml) was collected and stored at -80°C. DNA was extracted from leukocytes and analyzed with the Illumina EPIC methylation array. Epigenetic age was estimated with different epigenetic clocks.
Clinical data were extracted from medical records. Women who became pregnant were contacted by phone after the expected date of delivery to collect pregnancy and delivery data. Pregnancy follow-up was also collected from routine clinical records.
In a predefined subgroup of the first 30 enrolled women under 40 years of age, a second blood sample was collected after ovarian stimulation, on the day of oocyte retrieval, in order to compare epigenetic age before and after stimulation.
The primary analysis was a logistic regression of live birth on epigenetic age, with multivariable adjustment for potential confounders such as chronological age, BMI, male age, leukocyte composition, smoking status and ovarian reserve. The planned sample size of 400 women (about 120 pregnancies) was based on a 1.2-year difference in biological age observed in a previous pilot study. Sensitivity analyses excluded women with spontaneous conception, treatment discontinuation, or cycles not reaching oocyte retrieval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing IVF/ICSI | – | Other: Peripheral blood sampling for epigenetic age estimationAdult women with an indication for IVF or ICSI, followed through their assisted reproduction cycle and pregnancy outcome. An additional blood aliquot (about 5 ml) was collected during routine blood draws at the pre-admission visit. In a predefined subgroup of the first 30 women under 40 years of age, a second blood sample was collected after ovarian stimulation, on the day of oocyte retrieval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women undergoing IVF or ICSI at two Italian assisted reproduction centers.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Indication for IVF or ICSI
- FSH levels below 15 IU/mL
- Signed informed consent
Key exclusion criteria (5 listed)
- Uterine abnormalities (fibroids, adenomyosis, endometrial polyps, uterine septum)
- Hydrosalpinx diagnosed on baseline ultrasound
- Severe male factor infertility (azoospermia with surgical sperm retrieval, cryptozoospermia, necrozoospermia)
- Systemic diseases that may negatively affect pregnancy and cause miscarriage (e.g., diabetes, uncompensated thyroid disease, antiphospholipid syndrome)
- Additional blood sampling subgroup: the first 30 enrolled women under 40 years of age who agreed to participate through a specific consent.
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 |
|---|---|---|
| Peripheral blood sampling for epigenetic age estimationCollection of an additional blood aliquot (about 5 ml) during routine blood draws; DNA extracted from leukocytes and analyzed with the Illumina EPIC methylation array to estimate epigenetic age. No additional visits or procedures beyond routine clinical practice. | Other | Women undergoing IVF/ICSI |
Primary outcome
Epigenetic age in women with and without live birth after IVF/ICSI
Time frame: From enrollment (pre-admission visit) to delivery of the pregnancy resulting from the ART cycle (approximately 12 months)
Epigenetic (biological) age estimated from DNA methylation of peripheral blood leukocytes (Illumina EPIC array), compared between women who achieved a live birth and women who did not.
1 secondary outcome
Change in epigenetic age after ovarian stimulation
Time frame: From enrollment (pre-admission visit) to the day of oocyte retrieval in the same ART cycle, assessed up to approximately 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Study results will be published in aggregated or anonymized form, so that participants cannot be identified.
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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.
Edgardo Somigliana, PhD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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 and Ovarian Aging, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Epigenetic age in women with and without live birth after IVF/ICSI (time frame: From enrollment (pre-admission visit) to delivery of the pregnancy resulting from the ART cycle (approximately 12 months)). 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 15 Oct 2026.