AnovulationNCT00453219
FHA: Characterization of Metabolic Status, Brain Circuitry, and Stress-Reactivity
An observational study of Anovulation and FHA, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anovulation, FHA, Eumenorrhea
- What is being tested?
- Screening evaluation, Meal Response and Blood Collection
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women ages 18-35
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anovulation, FHA, Eumenorrhea, Polycystic Ovary Syndrome
- Being tested
- Screening evaluation, Meal Response, Blood Collection, Functional MRI, Endocrine Assessment
- Medical subject headings
- Anovulation, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening evaluationProcedure or surgery
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.
Meal ResponseProcedure or surgery
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.
Blood CollectionGenetic
A blood sample will be collected and used to check for genetic markers of stress vulnerability.
Functional MRIProcedure or surgery
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.
Endocrine AssessmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women ages 18-35 years with regular ovulatory menstrual cycles Receives: Procedure: Screening evaluation; Procedure: Meal Response; Genetic: Blood Collection; Procedure: Functional MRI; Procedure: Endocrine Assessment | |
| 2 | Women ages 18-35 years with irregular or absent menstrual periods due to functional hypothalamic amenorrhea (FHA) also called stress-induced anovulation Receives: Procedure: Screening evaluation; Procedure: Meal Response; Genetic: Blood Collection; Procedure: Functional MRI; Procedure: Endocrine Assessment | |
| 3 | Women ages 18-35 years with irregular or absent menstrual periods due to polycystic ovary syndrome(PCOS). Receives: Procedure: Screening evaluation; Procedure: Meal Response; Genetic: Blood Collection; Procedure: Functional MRI; Procedure: Endocrine Assessment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startJul 2011
Why it stopped: prior to participant recruitment, PI left Emory, study stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnovulationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah L Berga, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453219
- Sponsor's protocol ID
- IRB00024918
- Status last verified
- Oct 2013
- First submitted
- 26 Mar 2007
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 14556820Marcus 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.
PubMed 11476778Berga 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.
PubMed 17308138
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Hypothalamic Amenorrhea: Characterization of Metabolic Status, Brain Circuitry, and Stress-reactivity
- ClinicalTrials.gov ID
- NCT00453219
- Acronym / sponsor ID
- IRB00024918
- Conditions
- Anovulation, FHA, Eumenorrhea, Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: prior to participant recruitment, PI left Emory, study stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jul 2011
- First posted
- 28 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Screening evaluation, Procedure: Meal Response, Genetic: Blood Collection, Procedure: Functional MRI, Procedure: Endocrine AssessmentWomen ages 18-35 years with regular ovulatory menstrual cycles |
| 2 | – | Procedure: Screening evaluation, Procedure: Meal Response, Genetic: Blood Collection, Procedure: Functional MRI, Procedure: Endocrine AssessmentWomen ages 18-35 years with irregular or absent menstrual periods due to functional hypothalamic amenorrhea (FHA) also called stress-induced anovulation |
| 3 | – | Procedure: Screening evaluation, Procedure: Meal Response, Genetic: Blood Collection, Procedure: Functional MRI, Procedure: Endocrine AssessmentWomen ages 18-35 years with irregular or absent menstrual periods due to polycystic ovary syndrome(PCOS). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women ages 18-35
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening evaluationA 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. | Procedure or surgery | 1, 2, 3 |
| Meal ResponseThe 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. | Procedure or surgery | 1, 2, 3 |
| Blood CollectionA blood sample will be collected and used to check for genetic markers of stress vulnerability. | Genetic | 1, 2, 3 |
| Functional MRIresearch 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. | Procedure or surgery | 1, 2, 3 |
| Endocrine Assessmentresearch 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. | Procedure or surgery | 1, 2, 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Background: PubMed 14556820Berga 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.
- Background: PubMed 11476778Marcus 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.
- Background: PubMed 17308138Berga 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah L Berga, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anovulation and FHA, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453219, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.