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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypothalamic Amenorrhea

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Chrisandra Shufelt, MD; Phone Number: 904-953-2160; Email: Shufelt.Chrisandra@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Florida
      • Contact: Chrisandra Shufelt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Premenopausal women with hypothalamic amenorrhea at Mayo Clinic Florida.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Chrisandra Shufelt, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Amenorrhea; Functional Hypothalamic Amenorrhea
• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Amenorrhea
• Other Study ID Numbers: 22-006348; R01HD106096 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No