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Effect of Rapamycin in Ovarian Aging

NCT ID: NCT05836025

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Perimenopausal

Keywords

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Premenopausal Perimenopause Fertility Women's health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Rapamycin

Participants randomized to the treatment arm will receive 5mg/week of rapamycin orally, for 12 weeks (3 months).

Group Type EXPERIMENTAL

Rapamycin

Intervention Type DRUG

5mg/week of rapamycin orally for 12 weeks

Placebo

Participants randomized to the placebo arm will receive placebo orally, for 12 weeks (3 months).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

5mg/week of placebo orally for 12 weeks

Interventions

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Rapamycin

5mg/week of rapamycin orally for 12 weeks

Intervention Type DRUG

Placebo

5mg/week of placebo orally for 12 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Samuel Zev Williams

Associate Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel Z. Williams, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AAAU1074

Identifier Type: -

Identifier Source: org_study_id