Effect of Rapamycin in Ovarian Aging

AAAU1074

The investigators are proposing a prospective, randomized, double-blind, placebo-controlled pilot study assessing the ability of low-dose rapamycin to delay ovarian aging in women. Animal studies have shown the potential of rapamycin in slowing or reversing some age-associated pathways.

2023-06-01

2024-05-01

2024-12-01

Recruiting

Early phase I

50

Inclusion Criteria: * Women aged 35-45 years * In the menopausal transition stage -3a * Have been unable to conceive based on diminished ovarian reserve and who have failed to develop any euploid embryos with IVF or who do not desire to conceive within the next 1.5 years * Have regular menstrual periods (with less than 7 days of variability) * Early follicular phase follicle stimulating hormone (FSH) levels \] \< 20 mIU/mL * Anti-müllerian hormone (AMH) levels of \>0.1 ng/mL * Antral Follicle Counts (AFC) of \>3 Exclusion Criteria: * Women with irregular menstrual cycles * Severe ovarian deficiency, or with no evidence of remaining follicles * Kidney or liver disease * Any significant medical disease, including cancer * Contraindications to receiving rapamycin

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2024-05-08