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

Recruiting

• Conditions: Hypothalamic Amenorrhea

• Registration Number: NCT05629377
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-29
• Study Start: 2023-01-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vascular inflammation	3 months	concentration of cytokines multiplex immunoassay platform
Heart Rate	3 months	Measured by Fitbit Versa 2 watch that tracks heart rate
Caloric intake and nutrition	3 days	Measured using a self-reported food diary
Vascular dysfunction	3 months	Measured by reactive hyperemic index (RHI)
Psychosocial stress	3 months	Measured by NIH PROMIS® short-form questionnaires
Step count	3 months	Measured by Fitbit Versa 2 watch that tracks steps per day, active and resting heart rate, sleep hours per day
Hypothalamic Amenorrhea (HA) duration	3 months	Duration of HA by month of amenorrhea (absence of menstruation)
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.
Physical activity level	3 months	Measured by Fitbit Versa 2 watch that tracks amount of light physical activity, moderate, and vigorous activity

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States