RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health

Quick Facts

Study Start:2023-01-17
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05629377

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.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Secondary amenorrhea of 3 or more consecutive months duration
  2. * 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.
  3. * Pre-menopause status.
  4. * Able to give informed consent.
  1. * A diagnosis for secondary amenorrhea including prolactinoma, Polycystic Ovary Syndrome (PCOS), premature ovarian insufficiency, pituitary surgery, infection or infarction
  2. * Pregnancy
  3. * Psychotropic/illicit drug use
  4. * Mental/neurological/major psychological disorders (other than depression and anxiety).
  5. * Parturition/lactating in the last 6-12 months.

Contacts and Locations

Study Contact

Chrisandra Shufelt, MD
CONTACT
904-953-2160
Shufelt.Chrisandra@mayo.edu

Principal Investigator

Chrisandra Shufelt, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic Florida
Jacksonville, Florida, 32224
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Chrisandra Shufelt, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-17
Study Completion Date2026-05

Study Record Updates

Study Start Date2023-01-17
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Functional Hypothalamic Amenorrhea
  • Amenorrhea

Additional Relevant MeSH Terms

  • Hypothalamic Amenorrhea