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

Mayo Clinic

Status: Enrolling

Conditions: Hypothalamic Amenorrhea

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05629377

R01HD106096 (U.S. NIH Grant/Contract)

22-006348

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.