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

Study Overview
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Brief Summary
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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.

Official Title
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Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health

Conditions
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Hypothalamic Amenorrhea

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Hypothalamic Amenorrhea, Amenorrhea