Study Stopped
prior to participant recruitment, PI left Emory, study stopped
FHA: Characterization of Metabolic Status, Brain Circuitry, and Stress-Reactivity
Functional Hypothalamic Amenorrhea: Characterization of Metabolic Status, Brain Circuitry, and Stress-reactivity
1 other identifier
observational
N/A
1 country
1
Brief Summary
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.
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2007
CompletedFirst Posted
Study publicly available on registry
March 28, 2007
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedOctober 30, 2013
October 1, 2013
March 26, 2007
October 29, 2013
Conditions
Study Arms (3)
1
Women ages 18-35 years with regular ovulatory menstrual cycles
2
Women ages 18-35 years with irregular or absent menstrual periods due to functional hypothalamic amenorrhea (FHA) also called stress-induced anovulation
3
Women ages 18-35 years with irregular or absent menstrual periods due to polycystic ovary syndrome(PCOS).
Interventions
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.
Eligibility Criteria
Women ages 18-35
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
Emory University
Atlanta, Georgia, 30322, United States
Related Publications (3)
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.
PMID: 14556820BACKGROUNDMarcus 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.
PMID: 11476778BACKGROUNDBerga 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.
PMID: 17308138BACKGROUND
Biospecimen
Blood samples will be collected, processed, and stored for the evaluation of genetic markers assocaited with stress vulnerability. Serum and plasma specimens will be collected and stored for the evaluation of factors associated with the regulation of reproduction.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah L Berga, MD
Emory University
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2007
First Posted
March 28, 2007
Study Start
July 1, 2011
Last Updated
October 30, 2013
Record last verified: 2013-10