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Completed
NCT07875140
Epigenetic Clock to Predict Ovarian Aging and Live Birth in ART
Conditions: Infertility Assisted Reproductive Technology, Ovarian Aging
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 400
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Location: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan
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 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.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older
* Indication for IVF or ICSI
* FSH levels below 15 IU/mL
* Signed informed consent
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07875140). StuddyBuddy aggregates publicly available trial information.