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Effect of Rapamycin in Ovarian Aging
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.
Conditions:
🦠 Perimenopausal
🗓️ Study Start (Actual) 1 June 2023
🗓️ Primary Completion (Estimated) April 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 35 Years to 45 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 April 2023
  • First Submitted that Met QC Criteria 17 April 2023
  • First Posted 1 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 July 2024
  • Last Update Posted 15 July 2024
  • Last Verified July 2024
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