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

NCT05629377 | Recruiting

• 2 other identifiers: 22-006348R01HD106096
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothalamic Amenorrhea

Keywords

Functional Hypothalamic Amenorrhea; Amenorrhea

Outcome Measures

Primary Outcomes (9)

• Hypothalamic Amenorrhea (HA) duration

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

  3 months

• Vascular dysfunction

  Measured by reactive hyperemic index (RHI)

  3 months

• Psychosocial stress

  Measured by NIH PROMIS® short-form questionnaires

  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.

  3 months

• Step count

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

  3 months

• Physical activity level

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

  3 months

• Heart Rate

  Measured by Fitbit Versa 2 watch that tracks heart rate

  3 months

• Caloric intake and nutrition

  Measured using a self-reported food diary

  3 days

• Vascular inflammation

  concentration of cytokines multiplex immunoassay platform

  3 months

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal women with hypothalamic amenorrhea at Mayo Clinic Florida.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Amenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chrisandra Shufelt, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chrisandra Shufelt, MD

CONTACT

904-953-2160; Shufelt.Chrisandra@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: November 29, 2022
• Study Start: January 17, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)