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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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07875140). StuddyBuddy aggregates publicly available trial information.