Aromatase Activity and Ovarian Growth Factors in African-American Versus Caucasian Women
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by (Responsible Party):
Janet E. Hall, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00334971
First received: June 7, 2006
Last updated: October 4, 2011
Last verified: October 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of the study is to understand how the ovarian follicle (the fluid filled structure in the ovary that contains the egg) makes estrogen and other hormones during normal aging, in women with different ethnic backgrounds, and in Fragile X premutation carriers.
During reproductive aging, estradiol levels are increased, a phenomenon that may be related to increased aromatase activity. The investigators' own preliminary data suggest that estradiol is increased in African-American women compared to Caucasian women, which may also be related to aromatase activity. In addition, the investigators have examined female fragile X premutation carriers who still have regular menstrual cycles and have demonstrated evidence of early ovarian aging compared to age-matched controls.
**WE ARE RECRUITING ONLY WOMEN WITH FRAGILE-X PREMUTATION**
| Condition | Intervention |
|---|---|
|
Healthy Fragile X Syndrome |
Procedure: Follicle Aspiration |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Aromatase Activity and Ovarian Growth Factors in Preovulatory Follicles |
Resource links provided by NLM:
Genetics Home Reference related topics:
fragile X syndrome
MECP2 duplication syndrome
PPM-X syndrome
Renpenning syndrome
tetrasomy 18p
MedlinePlus related topics:
Fragile X Syndrome
U.S. FDA Resources
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Serum androstenedione, E2, A/E2, inhibin A, and inhibin B [ Time Frame: at first day of menses until day after aspiration procedure ] [ Designated as safety issue: No ]
- Follicular fluid androstenedione, E2, A/E2, inhibin A, and inhibin B [ Time Frame: after aspiration procedure ] [ Designated as safety issue: No ]
- RT-PCR results for aromatase in aspirated follicular fluid, when follicle is > 14 mm [ Time Frame: after aspiration procedure ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 116 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Healthy Caucasian women 18-35 years old
|
Procedure: Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.
|
|
2
Healthy African-American women 18-35 years old
|
Procedure: Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.
|
|
3
Healthy Caucasian women 36-45 years old
|
Procedure: Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.
|
|
4
Female fragile X premutation carriers 18-45 years old
|
Procedure: Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.
|
Detailed Description:
The purpose of the study is to examine intrafollicular changes in aromatase and ovarian growth factors in reproductive aged women,African-American women compared to Caucasian controls, and Fragile X premutation carriers.
Hypotheses:
- Aromatase activity is up-regulated in preovulatory follicles with aging, accounting for the increased estradiol levels in the face of decreased inhibin secretion in reproductive aging.
- Increased estradiol in the face of normal inhibin A and inhibin B suggests up-regulation of aromatase in African-American women.
- Aromatase activity is down-regulated in preovulatory follicles in fragile X premutation carriers compared to age-matched controls and the activity is associated with FMR1 mRNA levels.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Reproductively Younger Non-African-American Women:
- 18-35 years of age
- Body mass index (BMI) less than or equal to 30
- Regular menstrual cycles (25-35 days long)
- Negative beta-human chorionic gonadotrophin (HCG)
- Normal prolactin and thyroid stimulating hormone (TSH) levels
- Hemoglobin greater than or equal to 11.0 gm/dl
- Luteal phase progesterone level indicating ovulation on a previous cycle (> 3 ng/ml)
- Not currently trying to get pregnant
- No blood donations within 2 months of initiating the blood sampling portion of the study
- On no medications thought to interfere with normal menstrual cycle dynamics
- Not current smokers or no exposure to passive smoke in the home or workplace (greater than 8 hours per day with a smoker of > 10 cigarettes per day)
- Normal platelet count and PT/PTT
- No history of pelvic adhesions and accessible ovarian position as assessed by transvaginal ultrasound
Reproductively Younger African-American Women:
- 18-35 years of age
- Meets all other inclusion criteria for the reproductively younger non-African-American population outlined above
Reproductively Older Non-African-American Women:
- 36-45 years of age
- Meets all other inclusion criteria for the reproductively younger non-African-American population outlined above.
Reproductive Aged Fragile X Premutation Carriers
- Fragile X premutation carriers, with FMR1 CGG repeat lengths between 41 and 200.
- 18-45 years of age
- Meets all other inclusion criteria for the reproductively younger non-African-American population outlined above.
Exclusion Criteria:
- Hemoglobin level less than 11 gm/dl at time of screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334971
Locations
| United States, Massachusetts | |
| Reproductive Endocrine Unit, Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Janet E Hall, M.D. | Massachusetts General Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Janet E. Hall, MD, Associate Physician, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00334971 History of Changes |
| Other Study ID Numbers: | 2002-P-001354, Sundry |
| Study First Received: | June 7, 2006 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
African-American estradiol luteinizing hormone follicle stimulating hormone androstenedione |
aromatase inhibins ovarian Healthy volunteers Fragile X |
Additional relevant MeSH terms:
|
Fragile X Syndrome Mental Retardation, X-Linked Mental Retardation Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Sex Chromosome Disorders Chromosome Disorders Congenital Abnormalities Genetic Diseases, Inborn |
Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Mitogens Follicle Stimulating Hormone Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013