Aromatase Activity and Ovarian Growth Factors in African-American Versus Caucasian Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Janet E. Hall, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00334971
First received: June 7, 2006
Last updated: November 5, 2013
Last verified: November 2013
  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:


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 2018
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: November 5, 2013
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 July 23, 2014