Genetic Epidemiology of Ovarian Aging

NCT00501800 | Active Not Recruiting

• 2 other identifiers: R01HD0448765R01HD044876
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Keywords

Reproductive Health; Fertility; Infertility; Genetics; Continental Population Groups; Epidemiology; Aging; Health

Outcome Measures

Primary Outcomes (1)

• Antral Follicle Counts

  AFC as measured by Transvaginal Ultrasound

  December 2014

Study Arms (5)

Caucasian

African American

Chinese

Latina (Mexican or Central American)

Filipina

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Aging (NIA): collaborator
• Kaiser Foundation Research Institute: collaborator
• Stanford University: collaborator
• University of Michigan: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Marcelle I. Cedars, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: November 1, 2006
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (1)