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

Mayo Clinic90 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hypothalamic Amenorrhea

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Hypothalamic Amenorrhea (HA) duration

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

Time frame: 3 months

Vascular dysfunction

Measured by reactive hyperemic index (RHI)

Time frame: 3 months

Psychosocial stress

Measured by NIH PROMIS® short-form questionnaires

Time frame: 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.

Time frame: 3 months

Step count

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

Time frame: 3 months

Physical activity level

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

Time frame: 3 months

Heart Rate

Measured by Fitbit Versa 2 watch that tracks heart rate

Time frame: 3 months

Caloric intake and nutrition

Measured using a self-reported food diary

Time frame: 3 days

Vascular inflammation

concentration of cytokines multiplex immunoassay platform

Time frame: 3 months

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts