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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-17

Study Completion Date

2026-05-31

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.

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Detailed Description

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Conditions

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Hypothalamic Amenorrhea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No