Aromatase Activity and Ovarian Growth Factors in African-American Versus Caucasian Women
NCT ID: NCT00334971
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
116 participants
INTERVENTIONAL
2004-09-30
2018-01-31
Brief Summary
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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\*\*
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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1
Healthy Caucasian women 18-35 years old
Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.
2
Healthy African-American women 18-35 years old
Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.
3
Healthy Caucasian women 36-45 years old
Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.
4
Female fragile X premutation carriers 18-45 years old
Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.
Interventions
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Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.
Eligibility Criteria
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Inclusion Criteria
* 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
Reproductively Older Non-African-American Women:
* 36-45 years of age
Reproductive Aged Fragile X Premutation Carriers
* Fragile X premutation carriers, with FMR1 CGG repeat lengths between 41 and 200.
* 18-45 years of age
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Janet E. Hall, MD
Associate Physician
Principal Investigators
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Janet E Hall, M.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Reproductive Endocrine Unit, Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Welt CK, McNicholl DJ, Taylor AE, Hall JE. Female reproductive aging is marked by decreased secretion of dimeric inhibin. J Clin Endocrinol Metab. 1999 Jan;84(1):105-11. doi: 10.1210/jcem.84.1.5381.
Santoro N, Brown JR, Adel T, Skurnick JH. Characterization of reproductive hormonal dynamics in the perimenopause. J Clin Endocrinol Metab. 1996 Apr;81(4):1495-501. doi: 10.1210/jcem.81.4.8636357.
Reame NE, Kelche RP, Beitins IZ, Yu MY, Zawacki CM, Padmanabhan V. Age effects of follicle-stimulating hormone and pulsatile luteinizing hormone secretion across the menstrual cycle of premenopausal women. J Clin Endocrinol Metab. 1996 Apr;81(4):1512-8. doi: 10.1210/jcem.81.4.8636360.
Klein NA, Battaglia DE, Fujimoto VY, Davis GS, Bremner WJ, Soules MR. Reproductive aging: accelerated ovarian follicular development associated with a monotropic follicle-stimulating hormone rise in normal older women. J Clin Endocrinol Metab. 1996 Mar;81(3):1038-45. doi: 10.1210/jcem.81.3.8772573.
MacNaughton J, Banah M, McCloud P, Hee J, Burger H. Age related changes in follicle stimulating hormone, luteinizing hormone, oestradiol and immunoreactive inhibin in women of reproductive age. Clin Endocrinol (Oxf). 1992 Apr;36(4):339-45. doi: 10.1111/j.1365-2265.1992.tb01457.x.
Burger HG, Dudley EC, Hopper JL, Shelley JM, Green A, Smith A, Dennerstein L, Morse C. The endocrinology of the menopausal transition: a cross-sectional study of a population-based sample. J Clin Endocrinol Metab. 1995 Dec;80(12):3537-45. doi: 10.1210/jcem.80.12.8530596.
Welt CK, Smith ZA, Pauler DK, Hall JE. Differential regulation of inhibin A and inhibin B by luteinizing hormone, follicle-stimulating hormone, and stage of follicle development. J Clin Endocrinol Metab. 2001 Jun;86(6):2531-7. doi: 10.1210/jcem.86.6.7597.
Schneyer AL, Fujiwara T, Fox J, Welt CK, Adams J, Messerlian GM, Taylor AE. Dynamic changes in the intrafollicular inhibin/activin/follistatin axis during human follicular development: relationship to circulating hormone concentrations. J Clin Endocrinol Metab. 2000 Sep;85(9):3319-30. doi: 10.1210/jcem.85.9.6767.
Khoury MJ, Erickson JD. Maternal factors in dizygotic twinning: evidence from interracial crosses. Ann Hum Biol. 1983 Sep-Oct;10(5):409-15. doi: 10.1080/03014468300006601.
KNOX G, MORLEY D. Twinning in Yoruba women. J Obstet Gynaecol Br Emp. 1960 Dec;67:981-4. doi: 10.1111/j.1471-0528.1960.tb09255.x. No abstract available.
Myrianthopoulos NC. An epidemiologic survey of twins in a large, prospectively studied population. Am J Hum Genet. 1970 Nov;22(6):611-29. No abstract available.
Martin NG, Robertson DM, Chenevix-Trench G, de Kretser DM, Osborne J, Burger HG. Elevation of follicular phase inhibin and luteinizing hormone levels in mothers of dizygotic twins suggests nonovarian control of human multiple ovulation. Fertil Steril. 1991 Sep;56(3):469-74. doi: 10.1016/s0015-0282(16)54542-7.
Faerstein E, Szklo M, Rosenshein NB. Risk factors for uterine leiomyoma: a practice-based case-control study. II. Atherogenic risk factors and potential sources of uterine irritation. Am J Epidemiol. 2001 Jan 1;153(1):11-9. doi: 10.1093/aje/153.1.11.
Sondik EJ. Breast cancer trends. Incidence, mortality, and survival. Cancer. 1994 Aug 1;74(3 Suppl):995-9. doi: 10.1002/1097-0142(19940801)74:3+3.0.co;2-m.
Perry HM 3rd, Horowitz M, Morley JE, Fleming S, Jensen J, Caccione P, Miller DK, Kaiser FE, Sundarum M. Aging and bone metabolism in African American and Caucasian women. J Clin Endocrinol Metab. 1996 Mar;81(3):1108-17. doi: 10.1210/jcem.81.3.8772584.
Woods MN, Barnett JB, Spiegelman D, Trail N, Hertzmark E, Longcope C, Gorbach SL. Hormone levels during dietary changes in premenopausal African-American women. J Natl Cancer Inst. 1996 Oct 2;88(19):1369-74. doi: 10.1093/jnci/88.19.1369.
Woods MN, Gorbach SL, Longcope C, Goldin BR, Dwyer JT, Morrill-LaBrode A. Low-fat, high-fiber diet and serum estrone sulfate in premenopausal women. Am J Clin Nutr. 1989 Jun;49(6):1179-83. doi: 10.1093/ajcn/49.6.1179.
Manson JM, Sammel MD, Freeman EW, Grisso JA. Racial differences in sex hormone levels in women approaching the transition to menopause. Fertil Steril. 2001 Feb;75(2):297-304. doi: 10.1016/s0015-0282(00)01723-4.
Welt CK, Schneyer AL. Differential regulation of inhibin B and inhibin a by follicle-stimulating hormone and local growth factors in human granulosa cells from small antral follicles. J Clin Endocrinol Metab. 2001 Jan;86(1):330-6. doi: 10.1210/jcem.86.1.7107.
Welt CK, Lambert-Messerlian G, Zheng W, Crowley WF Jr, Schneyer AL. Presence of activin, inhibin, and follistatin in epithelial ovarian carcinoma. J Clin Endocrinol Metab. 1997 Nov;82(11):3720-7. doi: 10.1210/jcem.82.11.4345.
Shaw ND, Srouji SS, Welt CK, Cox KH, Fox JH, Adams JM, Sluss PM, Hall JE. Evidence that increased ovarian aromatase activity and expression account for higher estradiol levels in African American compared with Caucasian women. J Clin Endocrinol Metab. 2014 Apr;99(4):1384-92. doi: 10.1210/jc.2013-2398. Epub 2013 Nov 27.
Other Identifiers
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Sundry
Identifier Type: OTHER
Identifier Source: secondary_id
2002-P-001354
Identifier Type: -
Identifier Source: org_study_id