NCT03825120: OVACV

The Longitudinal Evaluation of Ovarian Aging and Cardiovascular Risk

ENROLLING BY INVITATION Last updated 19 September 2024

What this trial tests

trial in Infertility in 865 participants. Enrolling by invitation.

Timeline

15 August 2018

Primary endpoint
2 May 2025

2 December 2025

Quick facts

Lead sponsor	University of California, San Francisco
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	865
Start date	15 August 2018
Primary completion	2 May 2025
Estimated completion	2 December 2025
Sites	1 location across United States

Conditions studied

• Infertility — all drugs for Infertility →
• Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →

Sponsor

University of California, San Francisco

Who can join

Adults 35 to 55, female only, with Infertility or Cardiovascular Risk Factor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Despite significant improvements in prevention and treatment of cardiovascular disease (CVD), the growing aging population suggests CVD will continue to pose a significant public health burden. Women are a special group where microvascular disease is more common and traditional risk factors may not fully identify risk. Women's reproductive history (e.g. menarcheal age, menstrual cycles, infertility, pregnancy, menopause) may pose unique risk and suggests an opportunity for new approaches. The investigators propose a women-centered approach for early identification of women at risk that investigates the unique loss of reproductive function at an age long before other vital systems fail. Despite its importance, little is known about the determinants or correlates of ovarian aging, or the health implications, especially in diverse communities. Only recently have reliable biomarkers of the remaining oocyte pool been available for use in normally cycling women. This availability gives us a unique opportunity to characterize the association between "ovarian age" (cross-sectional) and the rate of "ovarian aging" or oocyte decline over time (longitudinal) and the health implications of accelerated oocyte loss. The investigators hypothesize ovarian age/aging provides a window onto the general health of women. The investigators suggest it is not the progressive deficiency of estrogen with menopause that increases risk, but common underlying cellular aging mechanisms first evident in young populations as lower ovarian reserve (follicle number) due to the unique sensitivity of the ovary.

Studies of cellular aging focused on mitochondrial dysfunction, oxidative stress, inflammation, and telomere length have identified correlations with CVD risk. Improved understanding of the mechanisms of cellular aging suggests telomere shortening and dysfunction may drive mitochondrial dysfunction and potentially the parallel between cellular aging and CVD. The oocyte is particularly sensitive to mitochondrial dysfunction, having 10 times the number of mitochondria as any somatic cell. Additionally, mitochondrial dysfunction and telomere shortening have been associated with ovarian aging. This begs the question of whether, given the susceptibility of the ovary to mitochondrial dysfunction, accelerated ovarian aging may be a harbinger of subsequent CVD risk. To address this critical question, the investigators propose to leverage the largest and most ethnically diverse population of normal reproductive-aged women, with detailed measures of ovarian age, and to deploy peripheral endothelial function testing, a non-invasive sensitive marker of early CVD risk. Ovarian aging is thought to be largely genetically determined, but the impact of race/ethnicity has not been fully explored. Evaluating the impact of ethnicity on ovarian aging, and combining this information with the impact of modifiable behavioral risk factors, may help clarify CVD risk in young, ethnically-diverse, reproductive-age women. The investigators believe improving our understanding of factors that affect the rate of oocyte/follicle loss and the relationship with CVD risk factors will promote a novel method to identify women at earlier and/or increased cardiac risk.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.