Hypothalamic AmenorrheaARCHNCT05629377
Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)
An observational study of Hypothalamic Amenorrhea, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hypothalamic Amenorrhea
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 1 Dec 2026
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Premenopausal women with hypothalamic amenorrhea at Mayo Clinic Florida.
Who may be able to join
- Secondary amenorrhea of 3 or more consecutive months duration
- Include the screening hormones (eg, estradiol (E2) < 50 pg/ml, Follicle-Stimulating Hormone (FSH) <10 mIU/ml, and Luteinizing Hormone (LH) < 10mIU/ml and other HA-defining hormones); or clinical diagnosis of HA by medical providers.
- Pre-menopause status.
- Able to give informed consent.
Who cannot join
- A diagnosis for secondary amenorrhea including prolactinoma, Polycystic Ovary Syndrome (PCOS), premature ovarian insufficiency, pituitary surgery, infection or infarction
- Pregnancy
- Psychotropic/illicit drug use
- Mental/neurological/major psychological disorders (other than depression and anxiety).
- Parturition/lactating in the last 6-12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health
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
- Hypothalamic Amenorrhea
- Keywords
- Functional Hypothalamic Amenorrhea, Amenorrhea
- Medical subject headings
- Amenorrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothalamic Amenorrhea (HA) duration
Duration of HA by month of amenorrhea (absence of menstruation)
Measured: 3 months
Vascular dysfunction
Measured by reactive hyperemic index (RHI)
Measured: 3 months
Psychosocial stress
Measured by NIH PROMIS® short-form questionnaires
Measured: 3 months
Perceived stress
Measured by the validate perceived stress scale questionnaire, a 10-item questionnaire, scores range from 0 to 40; higher scores indicate higher levels of perceived stress.
Measured: 3 months
Step count
Measured by Fitbit Versa 2 watch that tracks steps per day, active and resting heart rate, sleep hours per day
Measured: 3 months
Physical activity level
Measured by Fitbit Versa 2 watch that tracks amount of light physical activity, moderate, and vigorous activity
Measured: 3 months
Heart Rate
Measured by Fitbit Versa 2 watch that tracks heart rate
Measured: 3 months
Caloric intake and nutrition
Measured using a self-reported food diary
Measured: 3 days
Vascular inflammation
concentration of cytokines multiplex immunoassay platform
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start17 Jan 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothalamic AmenorrheaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Chrisandra L. Shufelt, MD, Mayo Clinic
- Investigators
- Chrisandra Shufelt, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629377
- Sponsor's protocol ID
- 22-006348
- Other IDs
- R01HD106096
- Acronym
- ARCH
- Status last verified
- Jun 2026
- First submitted
- 14 Oct 2022
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No