Effect of Rapamycin in Ovarian Aging

Last updated: January 3, 2025
Sponsor: Columbia University
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

Rapamycin

Placebo

Clinical Study ID

NCT05836025
AAAU1074
  • Ages 35-45
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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 failedto develop any euploid embryos with IVF or who do not desire to conceive within thenext 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

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

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Rapamycin
Phase: 2
Study Start date:
June 01, 2023
Estimated Completion Date:
September 30, 2026

Study Description

One of the earliest and most profound changes associated with human aging is the rapid decline in ovarian follicular activity and reproductive capacity. Beginning around age 35, fertility rates decline as the number and quality of oocytes fall, culminating in the onset of menopause around age 51. The onset of menopause has profound socioeconomic, quality of life, and health implications, including increasing the risks of cardiovascular disease, osteoporosis, cognitive decline and dementia. While human lifespan has increased, the age of menopause has remained largely unchanged, leaving more women living an ever-larger proportion of their lives in a postmenopausal state. The narrow reproductive window adds socioeconomic pressure on women to complete childbearing within a limited timeframe, or preserve their fertility with egg or embryo freezing. The investigators and others have demonstrated that rapamycin can delay ovarian aging in mice.

The purpose of this pilot study is to determine whether the same may be true in humans. Extending the reproductive lifespan will reduce the time pressure on women to complete childbearing and will allow more women to spend more of their lives in the premenopausal status and delay the negative healthy consequences of menopause.

Connect with a study center

  • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

    New York, New York 10032
    United States

    Site Not Available

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