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

Hypothalamic Amenorrhea Clinical Trial

— ARCH  

Official title:

Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629377
• Other study ID #: 22-006348
• Secondary ID: R01HD106096
• Status: Recruiting
• Start date: January 17, 2023
• Est. completion date: May 2026

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Chrisandra Shufelt, MD
• Phone: 904-953-2160
• Email: Shufelt.Chrisandra[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amenorrhea
• Hypothalamic Amenorrhea

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

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