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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, United States
Measure of Ovarian Reserve
Ovarian reserve will be determined using AMH
Time frame: Up to 1 year
TVU
TVUs will be used to measure follicle growth
Time frame: Up to 1 year
Estradiol (E2) Level
Estradiol levels will be measured.
Time frame: Day 21 of menstrual cycle
FSH Level
Follicle stimulating hormone (FSH) levels will be measured.
Time frame: Day 21 of menstrual cycle
Klotho Level
Klotho levels will be measured.
Time frame: Day 21 of menstrual cycle
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