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NCT Number: NCT05629377

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypothalamic Amenorrhea Amenorrhea Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Hypothalamic Amenorrhea (HA) duration

    Time frame: 3 months

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

  2. Vascular dysfunction

    Time frame: 3 months

    Measured by reactive hyperemic index (RHI)

  3. Psychosocial stress

    Time frame: 3 months

    Measured by NIH PROMIS® short-form questionnaires

  4. Perceived stress

    Time frame: 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

    Time frame: 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

    Time frame: 3 months

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

  7. Heart Rate

    Time frame: 3 months

    Measured by Fitbit Versa 2 watch that tracks heart rate

  8. Caloric intake and nutrition

    Time frame: 3 days

    Measured using a self-reported food diary

  9. Vascular inflammation

    Time frame: 3 months

    concentration of cytokines multiplex immunoassay platform

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study title

Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health

Acronym: ARCH

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2022
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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