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Ovarian AgingBEACONNCT07621965

The Bone and hEArt Health Consequences of Ovarian agiNg (BEACON) Study

An observational study of Ovarian Aging and Adverse Pregnancy Outcomes, run by Indiana University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

Ovarian aging is a major driver of a woman's long-term health and disease risk. In particular, the rapid decline in the ovarian reserve that occurs with the menopause transition is linked to a striking increase in the risk for both cardiometabolic disease and osteoporosis. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Ovarian Aging, Adverse Pregnancy Outcomes
How many people
655 participants
Where
No sites listed yet
Study dates
1 Apr 2027to 30 Mar 2032
Phase
Observational

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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Indiana University nuMoM2b-Heart Health Study participants.

Who may be able to join

  • We will include all IU study participants (n=655) for these analyses to characterize the ovarian aging trajectory of the cohort over time. The approach will allow us to move forward with the ovarian aging biomarker assays while recruitment for the in-person visit is ongoing. We will recruit a subgroup of current the IU cohort (n=352) to complete an in-person study visit at the FIT Core and Clinical Research Center. We will only recruit those who are at least 35 years old to this subgroup.

Who cannot join

  • We will exclude any potential participants who are unable to provide written informed consent in English or Spanish (the only languages allowed at the IU site for nuMoM2b), if the participant is currently pregnant, has undergone recent major surgery or sustained major injury or broken bones within 6 months of recruitment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

David Haas, MD contact

13172742027

dahaas@iu.edu

About this study

Ovarian aging is a major driver of a woman's long-term health and disease risk. In particular, the rapid decline in the ovarian reserve that occurs with the menopause transition is linked to a striking increase in the risk for both cardiometabolic disease and osteoporosis. A growing body of evidence has demonstrated that earlier age at menopause further exacerbates this risk for ischemic stroke, heart disease, and non-traumatic osteoporotic fracture. Thus, the identification of factors that accelerate ovarian aging is likely to lead to increased incidence and earlier onset of these conditions. Adverse pregnancy outcomes (APO) such as gestational diabetes, hypertensive disorders of pregnancy, and stillbirth, are major pathophysiological states that have the potential to accelerate depletion of the ovarian reserve due to the chronic inflammatory state, oxidative stress, and epigenetics changes that ensue. This proposal seeks to determine if APOs impact the ovarian aging trajectory and subsequent cardiometabolic and musculoskeletal health outcomes. Our central hypothesis is that APOs will accelerate ovarian aging, resulting in greater incidence and earlier onset of cardiometabolic disease and musculoskeletal decline. This hypothesis will be tested by accomplishing three aims designed to: 1) define the trajectory of ovarian aging and the impact of APOs on indicators of ovarian aging over time; 2) correlate the ovarian aging trajectory with the development of cardiometabolic risk; and 3) determine the association of ovarian aging biomarker trajectory on musculoskeletal health. To accomplish these aims we will capitalize on a subset of participants from the large, multisite nuMoM2b cohort that has been followed for fifteen years since the time of their first pregnancy. This project, the Bone and hEArt health Consequences of Ovarian agiNg (BEACON) Study, will utilize the extensive health, behavior, psychosocial and pregnancy data in this cohort, paired with biospecimens from their initial pregnancy and follow-up visits (3-7 \& 7-12 years after pregnancy), as well as data and specimens collected on participants completing an additional study visit. This proposal has the unique opportunity to provide longitudinal insight into the role of APOs in ovarian aging. If APOs are shown to accelerate ovarian aging, this mechanism may contribute to earlier onset of vascular dysfunction, metabolic disease, and musculoskeletal decline that would highlight the need for revised risk stratification for women with APOs, earlier screening (e.g., bone density, blood pressure \& lipids), and the development of targeted prevention strategies. Moreover, these findings could identify critical windows for intervention and reveal novel targets for earlier and more effective therapeutic strategies.

Keywords
ovarian aging, perimenopause, menopause, cardiovascular health, musculoskeletal health

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ovarian aging

    AMH trajectory

    Measured: 18 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start1 Apr 2027 (estimated)
  3. Primary completion30 Mar 2032 (estimated)
  4. Study completion30 Mar 2032 (estimated)

Resources

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
655 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07621965
Sponsor's protocol ID
31956
Acronym
BEACON
Status last verified
May 2026
First submitted
27 May 2026
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Through HHS-approved methods like DASH or BioData Catalyst

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