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Sponsors and Collaborators: |
University of California, San Francisco Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Aging (NIA) Kaiser Foundation Research Institute Stanford University University of Michigan |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00501800 |
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.
Condition |
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Infertility |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Genetic Epidemiology of Ovarian Aging |
Blood, urine
Estimated Enrollment: | 1250 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | March 2010 |
Groups/Cohorts |
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Caucasian |
African American |
Chinese |
Latina (Mexican or Central American) |
Filipina |
This is a cross-sectional study with a subgroup followed longitudinally over time. This study consists of four basic components:
Specific Aims:
The primary goal of this study is to demonstrate the relationship between antral follicle count and common genetic polymorphisms and the effect of modification of environmental factors. To achieve this goal, our multidisciplinary team proposes to recruit a random sample of 1,250 regularly cycling, ethnically diverse women, ages 25-45, who belong to the Northern California Kaiser Permanente Medical Care (KPMC) Program in San Francisco.
This study will provide evidence to support ultrasound evaluation as a non-invasive marker of ovarian aging. This and the genetic testing may lead to an opportunity for prospective identification of patients at risk for early decline in ovarian function. The ability to accurately generate and share this type of information will allow women to become proactive in managing their fertility as well as to better understand their risks associated with reproductive aging. The recruitment of a large, population-based cohort will increase the generalizability of the data generated. The ethnic diversity of this population will allow multiple comparisons to identify true "risk factors" for early, and/or accelerated, ovarian aging and their correlation with ethnicity.
Ages Eligible for Study: | 25 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Study Population will be drawn from members of Northern California Kaiser Permanente Health Plan utilizing the Kaiser Permanente Division of Research database to identify potentially eligible subjects.
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Deborah Trevithick, RN MS 415-353-9980 deborah.trevithick@ucsfmedctr.org | |
Contact: Tatiana Carranza, BA 415-353-4305 Tatiana.Carranza@ucsfmedctr.org | |
Principal Investigator: Marcelle I. Cedars, M.D. | |
Kaiser Permanente, Division of Research | Recruiting |
Oakland, California, United States, 94612 | |
Contact: Rosemary Murphy, BS 510-891-3492 rosemary.murphy@kp.org | |
Contact: Mariana Pereyra 510-891-3406 mariana.pereyra@kp.org | |
Principal Investigator: Barbara Sternfeld, Ph.D. |
Principal Investigator: | Marcelle I. Cedars, M.D. | University of California, San Francisco |
Responsible Party: | University of California, San Francisco ( Marcelle I. Cedars, MD/Professor, Department of Obstetrics, Gynecology, and Reproductive Services ) |
Study ID Numbers: | R01 HD044876 |
Study First Received: | July 12, 2007 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00501800 |
Health Authority: | United States: Institutional Review Board |
Reproductive Health Fertility Infertility Genetics |
Continental Population Groups Epidemiology Aging Health |
Genital Diseases, Female Infertility Genital Diseases, Male |