Functional Hypogonadotropic Hypogonadism, Hypothalamic Amenorrhea, Hypothalamic Amenorrhea, Functional
Conditions
Keywords
Anovulation, Estrogen Loss, Hypoestrogenemia
Brief summary
The purpose of this study is to to build a registry of women with early estrogen loss due to Functional Hypothalamic Amenorrhea (FHA) to understand the prevalence, racial and ethnic diversity of this condition.
Interventions
OTHERAutomated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
Subjects will complete the ASA food diary for 2 weekdays and 1 weekend day
OTHERREVEAL Questionnaire
Subjects will complete the REVEAL questionnaire form. This form includes questions about current and past medical history, including reproductive history, lifestyle specifics, and assessment of current health status.
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 3 or more months of consecutive amenorrhea with a diagnosis of functional hypothalamic amenorrhea or screening hormones consistent with functional hypothalamic amenorrhea including but not limited to: * Estradiol: \< 50pg/mL * LH: \< 10 IU/mL * FSH: \< 10 IU * Testosterone: 2 - 45 ng/dL * Free Testosterone: 0.1 - 6.4 pg/mL * FT4: 0.93 - 1.70 ng/dL * Prolactin: \< 20 ng/mL * AMH: \> 1 ng/mL * Urine or serum human chorionic gonadotropin: Negative * LH:FSH Ratio \<1 * No signs of male-like hair growth on the upper lip, chin, chest, abdomen, buttocks, or back * Does not have a diagnosis for secondary amenorrhea, including prolactinoma, PCOS, premature ovarian insufficiency, pituitary surgery, infection, or infarction * Premenopausal status determined by WISE criteria * Able to give informed consent * Able to read English
Exclusion criteria
* Parturition/lactating in the last 6-12 months * Lack of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Participants | 5 years | Establish and maintain a comprehensive registry of patients diagnosed with Functional Hypothalamic Amenorrhea (FHA). This registry will include detailed demographic information, clinical data, and longitudinal follow-up to track the prevalence, underlying causes, risk factors, and prognosis of FHA. It will also facilitate the collection of data on racial and ethnic disparities, lifestyle factors, psychological stressors, hormonal imbalances, and the impact of various treatment interventions on long-term health outcomes collected through questionnaires done at baseline and yearly. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessing the Impact of Amenorrhea on Women's Health: Symptoms, Care Experiences, and Work Productivity | 5 years | Improve understanding of women's overall experience of Functional Hypothalamic Amenorrhea (FHA) by documenting the types of care received, frequency and quality of healthcare interactions, and patient satisfaction with the care provided. This includes detailed assessments of specific treatments or therapies received, the involvement of multidisciplinary care approaches, and the extent of follow-up care. Additionally, to quantify the impact of FHA on lost work productivity, including the number of workdays missed, impact on work performance, and economic burden associated with amenorrhea-related issues, measured at baseline and then yearly using questionnaires. |
| Impact of Social, Early Life, and Pregnancy Factors on Functional Hypothalamic Amenorrhea | 5 years | Enhance the understanding of how social determinants of health-such as socioeconomic status, education, access to healthcare, and community environment-contribute to the development of Functional Hypothalamic Amenorrhea (FHA). Additionally, the study will explore the impact of childhood adversity, including exposure to trauma, abuse, neglect, or chronic stress, on the likelihood of developing FHA. The relationship between pregnancy complications, such as preterm birth, miscarriage, or gestational conditions, and the onset of FHA will also be analyzed. Data will be collected through baseline and annual questionnaires throughout the study, providing a comprehensive understanding of these factors' roles in the development of FHA. |
Countries
United States
Contacts
Primary ContactChandler E. Palmer, MHA
Backup ContactChrisandra L Shufelt, MD
Outcome results
None listed