Genetic Epidemiology of Ovarian Aging (NCT00501800) | Clinical Trial Compass
UnknownNot Applicable
Genetic Epidemiology of Ovarian Aging
United States1,250 participantsStarted 2006-11
Plain-language summary
The purpose of this study is to identify clinical and genetic markers of ovarian aging. In this process, we will evaluate environmental factors that may affect fertility and the age at which fertility declines, and may influence the age at which women enter menopause. Wide variability exists between women both in the age at which menopause occurs and the rate of decline in oocyte number and reproductive capability. As the loss of ovarian function has profound impact on women's hormonal milieu and their subsequent risk for the development of disease, improving our understanding of the factors that determine the timing and rate of reproductive aging is critical to improving quality of life for all women. In addition, improving our understanding of reproductive aging has profound economic, and social, implications given the complex choices women face regarding the timing of childbearing and the growing burden of infertility. While the inter-individual variability in age at menopause has a large genetic component and possible environmental influences, to date no studies have addressed the relationship between oocyte number as reflected by antral follicle count (AFC) and genetic inheritance.
We hypothesize that ovarian aging, as reflected by antral follicle count, is largely determined by common genetic polymorphisms that impact the initial oocyte endowment and/or the rate of oocyte loss over time thus lowering antral follicle count for any given age. We further hypothesize that antral follicle count will be an improved marker of ovarian aging. Thus, we propose a study of the genetic and environmental factors that influence age-specific variability in antral follicle count.
Who can participate
Age range
25 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 25-45 years
* Self-identifying as one of five specified race/ethnicities - Caucasian, Chinese, Filipino, African-American, or Hispanic (Mexican or Central American).
* Regular menstrual cycles (monthly bleeding with an interval of 25-35 days)
* Uterus and ovaries required.
Exclusion Criteria:
* Chronic medical illness such as heart, kidney, or liver disease or diabetes
* Endometriosis of ovary
* Prior surgical procedure for removal of ovarian cyst(s)
* Epilepsy
* Lupus
* Invasive cancer excluding squamous or basal cell skin cancers
* Prior treatment with chemotherapy or radiation therapy
* Use of any oral/systemic estrogen or progestin containing medication within a 3-month period
* Use of any central nervous system active medications known to disrupt the menstrual cycle (e.g. clonidine, aldomet)
* Psychiatric history involving functionally debilitating disturbance such as psychosis or major mood disorder requiring hospitalization or change in occupational or social functioning.
* Currently pregnant or breastfeeding
* Unable to speak and read English, Cantonese, or Spanish
* Concurrent participation in a clinical drug trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.