FHA: Characterization of Metabolic Status, Brain Circuitry, and Stress-Reactivity
October 29, 2013 updated by: Emory University
Functional Hypothalamic Amenorrhea: Characterization of Metabolic Status, Brain Circuitry, and Stress-reactivity
Functional Hypothalamic Amenorrhea (FHA), the spontaneous cessation of the menstrual cycle for at least 6 months after menstrual cyclicity has been established, is a common and reversible form of anovulation not due to discernible organic causes.
Whereas animal studies suggest an interaction of metabolic and psychosocial stress in the genesis of FHA, the distinct central mechanisms in humans are not clear.
On a behavioral level, FHA appears to depend on a complex interplay between individual stress susceptibility, stressful life events, and enduring metabolic challenge due to inappropriate attitudes towards eating and body image.
We will use a comparison group of ovulatory, eumenorrheic women (EW) and a contrast group of lean women with polycystic ovary syndrome (PCOS).
Although women with FHA and PCOS present with anovulation, each condition differs markedly in pathobiology (and health burden).
Contrasting women with FHA to those with PCOS will afford an opportunity to understand more about the interaction between metabolism, stress, and reproduction and to determine the extent to which differences between FHA and EW are attributable to reproductive compromise (anovulation) per se versus specific to the pathogenesis of FHA or PCOS.
We have used this approach to great advantage in the past to show that hypercortisolemia was confined to FHA and not PCOS (Berga 1997) and that dysfunctional (unrealistic) attitudes and decreased coping skills were reported more often in FHA than in PCOS and more in PCOS than EW.
Further, this approach of comparing 3 groups will allow us to improve therapeutic approaches for two principle causes of anovulatory infertility in women.
To accomplish this, we will study women with FHA, PCOS, and normal ovulatory women.
The study will take place over 2 months and women will make 4-5 outpatient visits to the Clinical Integration Network Center and will have one overnight stay for frequent blood sampling.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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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.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women ages 18-35
Description
Inclusion Criteria:
- Inclusion criteria for participation are a gynecological age (age since menarche) > 5 and < 25 years, and chronological age > 18 years, within 90-110% of ideal body weight as determined by the 1983 Metropolitan height and weight table for women, and exercise < 10 h/wk and run < 10 mi/wk, day-awake/night-asleep schedule.
- Women in the FHA and PCOS groups have to fulfill the diagnostic criteria of FHA or PCOS and to have all other causes of amenorrhea and anovulation excluded.
Exclusion Criteria:
- Exclusion criteria are smoking, medications, including psychotropic or illicit drugs, medical, neurological, or ophthalmologic disease except acuity problems, a weight loss or gain of > 10 lb within a year preceding or since the onset of amenorrhea, a major Axis I disorder other than depression, parturition in the last 12 months and/or lactating in the last 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Women ages 18-35 years with regular ovulatory menstrual cycles
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A detailed history will be taken and a physical examination performed along with a blood sample to verify ovulatory status in women with regular cycles and determine cause of anovulation in women with irregular or absent menstrual cycles.
The investigators are interested in how nutrition and metabolism can influence reproduction and they will look at how the body senses hunger and how it responses to food.
Blood samples will be collected and questionnaires given to assess responses and feeling about hunger and food.
A blood sample will be collected and used to check for genetic markers of stress vulnerability.
research participants will have an functional MRI scan of their brain while reviewing word lists associated with body image and emotions.
This procedure will last about 1 hour.
research participants will have a 30 hour inpatient hospital admission with every 15 minute blood sampling for 24 hours.
Hormone measures of stress, reproduction, and appetite will be obtained.
|
|
2
Women ages 18-35 years with irregular or absent menstrual periods due to functional hypothalamic amenorrhea (FHA) also called stress-induced anovulation
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A detailed history will be taken and a physical examination performed along with a blood sample to verify ovulatory status in women with regular cycles and determine cause of anovulation in women with irregular or absent menstrual cycles.
The investigators are interested in how nutrition and metabolism can influence reproduction and they will look at how the body senses hunger and how it responses to food.
Blood samples will be collected and questionnaires given to assess responses and feeling about hunger and food.
A blood sample will be collected and used to check for genetic markers of stress vulnerability.
research participants will have an functional MRI scan of their brain while reviewing word lists associated with body image and emotions.
This procedure will last about 1 hour.
research participants will have a 30 hour inpatient hospital admission with every 15 minute blood sampling for 24 hours.
Hormone measures of stress, reproduction, and appetite will be obtained.
|
|
3
Women ages 18-35 years with irregular or absent menstrual periods due to polycystic ovary syndrome(PCOS).
|
A detailed history will be taken and a physical examination performed along with a blood sample to verify ovulatory status in women with regular cycles and determine cause of anovulation in women with irregular or absent menstrual cycles.
The investigators are interested in how nutrition and metabolism can influence reproduction and they will look at how the body senses hunger and how it responses to food.
Blood samples will be collected and questionnaires given to assess responses and feeling about hunger and food.
A blood sample will be collected and used to check for genetic markers of stress vulnerability.
research participants will have an functional MRI scan of their brain while reviewing word lists associated with body image and emotions.
This procedure will last about 1 hour.
research participants will have a 30 hour inpatient hospital admission with every 15 minute blood sampling for 24 hours.
Hormone measures of stress, reproduction, and appetite will be obtained.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah L Berga, MD, Emory University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Berga SL, Marcus MD, Loucks TL, Hlastala S, Ringham R, Krohn MA. Recovery of ovarian activity in women with functional hypothalamic amenorrhea who were treated with cognitive behavior therapy. Fertil Steril. 2003 Oct;80(4):976-81. doi: 10.1016/s0015-0282(03)01124-5.
- Marcus MD, Loucks TL, Berga SL. Psychological correlates of functional hypothalamic amenorrhea. Fertil Steril. 2001 Aug;76(2):310-6. doi: 10.1016/s0015-0282(01)01921-5.
- Berga SL, Loucks TL. Use of cognitive behavior therapy for functional hypothalamic amenorrhea. Ann N Y Acad Sci. 2006 Dec;1092:114-29. doi: 10.1196/annals.1365.010.
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 Major Dates
Study Start
July 1, 2011
Study Registration Dates
First Submitted
March 26, 2007
First Submitted That Met QC Criteria
March 27, 2007
First Posted (Estimate)
March 28, 2007
Study Record Updates
Last Update Posted (Estimate)
October 30, 2013
Last Update Submitted That Met QC Criteria
October 29, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00024918
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