InfertilityNCT00501800
Genetic Epidemiology of Ovarian Aging
An observational study of Infertility, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 1,080 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to 31 Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
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.
Read the detailed description
This is a cross-sectional study with a subgroup followed longitudinally over time. This study consists of four basic components:
- identification and recruitment of a population-based sample of 1,250 regularly cycling women of diverse ethnicities, ages 25-45;
- a baseline examination on days 2-4 of the menstrual cycle, including a blood draw, transvaginal ultrasound examination, body size measurements, and questionnaires, to establish cross-sectional relations between the AFC and the genetic and environmental exposures of interest (see Specific Aims);
- genetic analyses of X-chromosome and autosomal mutations, deletions, and polymorphisms, implicated in the control of ovarian function; and
- follow-up examination, 3 years after baseline, completed by approximately one-third of the cohort (n=450), to begin to describe longitudinal relations between AFC and the exposures of interest and to identify markers predictive of accelerated follicle loss.
Specific Aims:
- Characterize antral follicle count (AFC) as a marker of ovarian age by comparing it to other available biomarkers, Follicle Stimulating Hormone (FSH), FSH/Lutenizing Hormone (LH), and inhibin B, and determine effect modification of these relationships by age.
- Examine the relationship between antral follicle counts and the frequencies of specific genetic polymorphisms in the Deleted in AZoospermia-Like (DAZL) and interacting protein genes.
- Determine the associations between race/ethnicity, body fat, and active and passive smoking and AFC, independently of age; if main effects are observed between genetic polymorphisms and AFC (Specific Aim 2), explore the effect modification of those relationships by race/ethnicity, body fat and active and passive smoking.
- Determine the change in AFC over a three-year period and its relation to genetic and environmental characteristics, based on the approximately 450 women who complete a 3-year follow-up examination.
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.
- Conditions
- Infertility
- Keywords
- Reproductive Health, Fertility, Infertility, Genetics, Continental Population Groups, Epidemiology, Aging, Health
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Caucasian | Not described | |
| African American | Not described | |
| Chinese | Not described | |
| Latina (Mexican or Central American) | Not described | |
| Filipina | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antral Follicle Counts
AFC as measured by Transvaginal Ultrasound
Measured: December 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startNov 2006
- Primary completion31 Jul 2012
- Study completion31 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Marcelle I. Cedars, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501800
- Sponsor's protocol ID
- R01HD044876
- Other IDs
- 5R01HD044876
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2007
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiology of Ovarian Aging
- ClinicalTrials.gov ID
- NCT00501800
- Acronym / sponsor ID
- R01HD044876
- Conditions
- Infertility
- Keywords
- Reproductive Health, Fertility, Infertility, Genetics, Continental Population Groups, Epidemiology, Aging, Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- 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
- Study start
- Nov 2006 (actual)
- Primary completion
- 31 Jul 2012 (actual)
- Study completion
- 31 Jul 2012 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a cross-sectional study with a subgroup followed longitudinally over time. This study consists of four basic components:
- identification and recruitment of a population-based sample of 1,250 regularly cycling women of diverse ethnicities, ages 25-45;
- a baseline examination on days 2-4 of the menstrual cycle, including a blood draw, transvaginal ultrasound examination, body size measurements, and questionnaires, to establish cross-sectional relations between the AFC and the genetic and environmental exposures of interest (see Specific Aims);
- genetic analyses of X-chromosome and autosomal mutations, deletions, and polymorphisms, implicated in the control of ovarian function; and
- follow-up examination, 3 years after baseline, completed by approximately one-third of the cohort (n=450), to begin to describe longitudinal relations between AFC and the exposures of interest and to identify markers predictive of accelerated follicle loss.
Specific Aims:
- Characterize antral follicle count (AFC) as a marker of ovarian age by comparing it to other available biomarkers, Follicle Stimulating Hormone (FSH), FSH/Lutenizing Hormone (LH), and inhibin B, and determine effect modification of these relationships by age.
- Examine the relationship between antral follicle counts and the frequencies of specific genetic polymorphisms in the Deleted in AZoospermia-Like (DAZL) and interacting protein genes.
- Determine the associations between race/ethnicity, body fat, and active and passive smoking and AFC, independently of age; if main effects are observed between genetic polymorphisms and AFC (Specific Aim 2), explore the effect modification of those relationships by race/ethnicity, body fat and active and passive smoking.
- Determine the change in AFC over a three-year period and its relation to genetic and environmental characteristics, based on the approximately 450 women who complete a 3-year follow-up examination.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Caucasian | – | – |
| African American | – | – |
| Chinese | – | – |
| Latina (Mexican or Central American) | – | – |
| Filipina | – | – |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antral Follicle Counts
Time frame: December 2014
AFC as measured by Transvaginal Ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelle I. Cedars, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antral Follicle Counts (time frame: December 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.