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

Description

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.

Conditions

Hypothalamic Amenorrhea

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Study Overview

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Study Details

Study 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.

Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health

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

Condition
Hypothalamic Amenorrhea
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Mayo Clinic Florida, Jacksonville, Florida, United States, 32224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

18 Years to 40 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Chrisandra Shufelt, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2026-05