Effect of Rapamycin in Ovarian Aging

Perimenopausal Clinical Trial

— Rapamycin  

Official title:

Effect of Rapamycin in Ovarian Aging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05836025
• Other study ID #: AAAU1074
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Stephanie Morgan
• Phone: 212-314-8837
• Email: sm3415[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Perimenopausal

Intervention

Drug:
• Rapamycin
5mg/week of rapamycin orally for 12 weeks

Other:
• Placebo
5mg/week of placebo orally for 12 weeks

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center / NewYork-Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Ovarian Reserve	Ovarian reserve will be determined using AMH	Up to 1 year
Secondary	TVU	TVUs will be used to measure follicle growth	Up to 1 year
Secondary	Estradiol (E2) Level	Estradiol levels will be measured.	Day 21 of menstrual cycle
Secondary	FSH Level	Follicle stimulating hormone (FSH) levels will be measured.	Day 21 of menstrual cycle
Secondary	Klotho Level	Klotho levels will be measured.	Day 21 of menstrual cycle