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Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05629377
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
90
Enrollment
1
Location
39.4
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health
    Actual Study Start Date :
    Jan 17, 2023
    Anticipated Primary Completion Date :
    May 1, 2026
    Anticipated Study Completion Date :
    May 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Hypothalamic Amenorrhea (HA) duration [3 months]

      Duration of HA by month of amenorrhea (absence of menstruation)

    2. Vascular dysfunction [3 months]

      Measured by reactive hyperemic index (RHI)

    3. Psychosocial stress [3 months]

      Measured by NIH PROMIS® short-form questionnaires

    4. Perceived stress [3 months]

      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.

    5. Step count [3 months]

      Measured by Fitbit Versa 2 watch that tracks steps per day, active and resting heart rate, sleep hours per day

    6. Physical activity level [3 months]

      Measured by Fitbit Versa 2 watch that tracks amount of light physical activity, moderate, and vigorous activity

    7. Heart Rate [3 months]

      Measured by Fitbit Versa 2 watch that tracks heart rate

    8. Caloric intake and nutrition [3 days]

      Measured using a self-reported food diary

    9. Vascular inflammation [3 months]

      concentration of cytokines multiplex immunoassay platform

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Florida Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Mayo Clinic
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    • Principal Investigator: Chrisandra Shufelt, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Chrisandra L. Shufelt, MD, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05629377
    Other Study ID Numbers:
    • 22-006348
    • R01HD106096
    First Posted:
    Nov 29, 2022
    Last Update Posted:
    Jan 31, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Amenorrhea

    Study Results

    No Results Posted as of Jan 31, 2023