An observational study in Infertility Assisted Reproductive Technology and Ovarian Aging, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Completed at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational
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.
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.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 232 studies on the registry; 83 are open to participants now.
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Adult women undergoing IVF or ICSI at two Italian assisted reproduction centers.
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Exclusion Criteria:
Additional blood sampling subgroup: the first 30 enrolled women under 40 years of age who agreed to participate through a specific consent.
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.
Other: Peripheral blood sampling for epigenetic age estimation
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.
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.
Time frame: From enrollment (pre-admission visit) to delivery of the pregnancy resulting from the ART cycle (approximately 12 months)
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.
Time frame: From enrollment (pre-admission visit) to the day of oocyte retrieval in the same ART cycle, assessed up to approximately 6 weeks
Plan to share: No — Individual participant data will not be shared. Study results will be published in aggregated or anonymized form, so that participants cannot be identified.
No publications or documents are linked to this record.
Ran from Mar 2025 to primary completion in Apr 2026, 13 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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