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Effect of Rapamycin in Ovarian Aging

Effect of Rapamycin in Ovarian Aging

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05836025
Acronym
Rapamycin
Enrollment
50
Registered
2023-05-01
Start date
2023-06-01
Completion date
2026-09-30
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perimenopausal

Keywords

Premenopausal, Perimenopause, Fertility, Women's health

Brief 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.

Detailed 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.

Interventions

DRUGRapamycin

5mg/week of rapamycin orally for 12 weeks

OTHERPlacebo

5mg/week of placebo orally for 12 weeks

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of Ovarian ReserveUp to 1 yearOvarian reserve will be determined using AMH

Secondary

MeasureTime frameDescription
Estradiol (E2) LevelDay 21 of menstrual cycleEstradiol levels will be measured.
FSH LevelDay 21 of menstrual cycleFollicle stimulating hormone (FSH) levels will be measured.
Klotho LevelDay 21 of menstrual cycleKlotho levels will be measured.
TVUUp to 1 yearTVUs will be used to measure follicle growth

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026