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


About this study

The purpose of this study is to use innovative remote patient monitoring and patient reported outcomes to investigate Hypothalamic Amenorrhea (HA) specific phenotype(s) related to cardiovascular disease (CVD) (and vascular inflammation).


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Aim 1 Inclusion Criteria for Clinical Registry (at Mayo Clinic):

  • Include the screening hormones (eg, estradiol (E2) < 50 pg/ml, FSH<10 mIU/ml, and LH < 10mIU/ml and other HA-defining hormones); or clinical diagnosis of Hypothalamic Amenorrhea (HA) by medical providers.
  • Premenopause status.
  • Able to give informed consent.
  • ≥ 18 and ≤ 40 years of age.

Aim 2 Inclusion Criteria for Nurse’s Health Study II Data (at Brigham and Women's Hospital):

  • Women with a recorded age at menarche who were premenopausal at the time of menstrual cycle report will be included.

Exclusion Criteria: 

Aim 1 Exclusion Criteria for Clinical Registry (at Mayo Clinic):

  • Psychotropic/illicit drug use.
  • Medical/neurological/major psychological disorders (other than depression and anxiety).
  • Parturition/lactating in the last 6-12 months.

Aim 2 Exclusion Criteria for Nurse’s Health Study II Data (at Brigham and Women's Hospital):

  • Analyses will exclude women who report CVD events before study baseline.
  • For risk factor endpoints, we will also exclude women reporting risk factors of interest at baseline.

Eligibility last updated 6/14/22. Questions regarding updates should be directed to the study team contact.


Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Chrisandra Shufelt, M.D.

Open for enrollment

Contact information:

Pamela Wong Lucio

(904) 953-9805


More information


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