Trials / Active Not Recruiting
Active Not RecruitingNCT05629377
Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)
Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 90 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
Hypothalamic amenorrhea (HA) occurs during reproductive years and results in stopped menstrual cycles and infertility which can be prolonged from months to years and is characterized by varying combinations of psychosocial stress, anxiety, high levels of physical activity, and/or weight loss. Data from our group indicates that one-third of women with HA (mean age: 27 yrs) have preclinical cardiovascular disease (CVD) measured noninvasively as vascular dysfunction and vascular inflammation. This study will use HA as a marker of fertility status for cardiovascular health and perform dense-phenotyping using remote patient monitoring (FitBit) and patient reported outcomes (questionnaires) to determine which HA phenotypes are related to preclinical CVD and inflammation.
Conditions
Timeline
- Start date
- 2023-01-17
- Primary completion
- 2026-05-01
- Completion
- 2026-05-01
- First posted
- 2022-11-29
- Last updated
- 2026-04-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05629377. Inclusion in this directory is not an endorsement.