HealthyNCT00334971
Aromatase Activity and Ovarian Growth Factors in African-American Versus Caucasian Women
A study testing Follicle Aspiration in people with Healthy and Fragile X Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Fragile X Syndrome
- What is being tested?
- Follicle Aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jan 2018
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 24Show fewer
- 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.
Who cannot join
- Hemoglobin level less than 11 gm/dl at time of screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Endocrine Unit, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Aromatase Activity and Ovarian Growth Factors in Preovulatory Follicles
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
Read the 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.
- Conditions
- Healthy, Fragile X Syndrome
- Being tested
- Follicle Aspiration
- Keywords
- African-American, estradiol, luteinizing hormone, follicle stimulating hormone, androstenedione, aromatase, inhibins, ovarian, Healthy volunteers, Fragile X
- Medical subject headings
- Fragile X Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follicle AspirationProcedure or surgery
Follicles will be aspirated using a transvaginal ultrasound guided needle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Healthy Caucasian women 18-35 years old Receives: Procedure: Follicle Aspiration |
| 2 | Other | Healthy African-American women 18-35 years old Receives: Procedure: Follicle Aspiration |
| 3 | Other | Healthy Caucasian women 36-45 years old Receives: Procedure: Follicle Aspiration |
| 4 | Other | Female fragile X premutation carriers 18-45 years old Receives: Procedure: Follicle Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum androstenedione, E2, A/E2, inhibin A, and inhibin B
Measured: at first day of menses until day after aspiration procedure
Follicular fluid androstenedione, E2, A/E2, inhibin A, and inhibin B
Measured: after aspiration procedure
RT-PCR results for aromatase in aspirated follicular fluid, when follicle is > 14 mm
Measured: after aspiration procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startSep 2004
- Primary completionJan 2012
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Janet E. Hall, MD, Massachusetts General Hospital
- Investigators
- Janet E Hall, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334971
- Sponsor's protocol ID
- 2002-P-001354
- Other IDs
- Sundry
- Status last verified
- Nov 2013
- First submitted
- 7 Jun 2006
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9920069Santoro 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.
PubMed 8636357Reame 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.
PubMed 8636360Klein 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.
PubMed 8772573MacNaughton 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.
PubMed 1424166Burger 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.
PubMed 8530596Welt 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.
PubMed 11397851Schneyer 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.
PubMed 10999828Khoury 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.
PubMed 6638936KNOX 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.
PubMed 13757217Myrianthopoulos 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.
PubMed 5518457Martin 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.
PubMed 1894024Faerstein 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.
PubMed 11159140Sondik 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.
PubMed 8039156Perry 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.
PubMed 8772584
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatase Activity and Ovarian Growth Factors in Preovulatory Follicles
- ClinicalTrials.gov ID
- NCT00334971
- Acronym / sponsor ID
- 2002-P-001354
- Conditions
- Healthy, Fragile X Syndrome
- Keywords
- African-American, estradiol, luteinizing hormone, follicle stimulating hormone, androstenedione, aromatase, inhibins, ovarian
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2004
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2018 (estimated)
- First posted
- 8 Jun 2006 (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.
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
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Follicle AspirationHealthy Caucasian women 18-35 years old |
| 2 | Other | Procedure: Follicle AspirationHealthy African-American women 18-35 years old |
| 3 | Other | Procedure: Follicle AspirationHealthy Caucasian women 36-45 years old |
| 4 | Other | Procedure: Follicle AspirationFemale fragile X premutation carriers 18-45 years old |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (1 listed)
- Hemoglobin level less than 11 gm/dl at time of screening
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 |
|---|---|---|
| Follicle AspirationFollicles will be aspirated using a transvaginal ultrasound guided needle. | Procedure or surgery | 1, 2, 3, 4 |
Primary outcome
Serum androstenedione, E2, A/E2, inhibin A, and inhibin B
Time frame: at first day of menses until day after aspiration procedure
Follicular fluid androstenedione, E2, A/E2, inhibin A, and inhibin B
Time frame: after aspiration procedure
RT-PCR results for aromatase in aspirated follicular fluid, when follicle is > 14 mm
Time frame: after aspiration procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
- Background: PubMed 9920069Welt 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.
- Background: PubMed 8636357Santoro 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.
- Background: PubMed 8636360Reame 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.
- Background: PubMed 8772573Klein 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.
- Background: PubMed 1424166MacNaughton 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.
- Background: PubMed 8530596Burger 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.
- Background: PubMed 11397851Welt 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.
- Background: PubMed 10999828Schneyer 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.
- Background: PubMed 6638936Khoury 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.
- Background: PubMed 13757217KNOX 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.
- Background: PubMed 5518457Myrianthopoulos 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.
- Background: PubMed 1894024Martin 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.
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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.
Janet E Hall, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follicle Aspiration in people with Healthy and Fragile X Syndrome, run by Massachusetts General Hospital 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 24 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: status not confirmed, as of the sponsor's last update on 6 Nov 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Serum androstenedione, E2, A/E2, inhibin A, and inhibin B (time frame: at first day of menses until day after aspiration procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00334971, which also lists 21 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 6 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.