HealthyNCT00006156
Feasibility Study for Development of an Early Test for Ovarian Failure
A study testing Drug: FSH in people with Healthy and Premature Ovarian Failure, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
This purpose of this study is to gain information about normal ovarian function that will be useful in developing a test for early detection of ovarian failure. The ovaries produce female hormones, such as estrogen, that are important in maintaining a woman's health. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Premature Ovarian Failure
- What is being tested?
- Drug: FSH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with normal ovarian function:
- Age 18 to 55.
- Normal body mass index (18-30 kg/m(2)).
- Normal menstrual cycles (between 25-35 days in length).
- Ovulatory serum progesterone concentrations (in excess of 6 ng/mL in the menstrual cycle just preceding the study cycle).
- Postmenopausal women (to serve as negative controls):
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- Greater than or equal to 60 years of age.
- Proven fertility (as evidenced by a history of pregnancy regardless of outcome).
- Normal body mass index (18-30 kg/m(2)).
- Naturally menopausal: amenorrhea for at least one year; serum FSH greater than 40 IU/mL.
- Women carriers of FMR1 premutations:
- Age 18 to 40.
- 50 to 200 CGG repeats.
- Normal menstrual cycles (between 25-35 days in length).
- Have previously had genetic counseling regarding their FMR1 status.
Who cannot join
- History of infertility or infertility in a first degree relative.
- Acute or chronic disease.
- Menopause due to surgery, radiation, or chemotherapy.
- Current use of oral contraceptives or hormone replacement therapy, or use of these agents within the previous 3 months.
- Use within the previous three months of any medication known to affect the hypothalamic-pituitary-ovarian axis (including over-the-counter and alternative medicines).
- History of excessive exercise (greater than 10 hours a week).
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- Girls will be excluded because there are no data regarding FSH use in children.
- Smokers.
- Pregnant.
- Breast feeding.
- Persistent ovarian masses.
- History of tumors of the ovary, breast, uterus, hypothalamus, or pituitary.
- History of breast or endometrial cancer.
- History of hypersensitivity to recombinant FSH or any one of its excipients.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: FSH-Stimulated Inhibin B as a Marker for Early Ovarian Insufficiency
This purpose of this study is to gain information about normal ovarian function that will be useful in developing a test for early detection of ovarian failure. The ovaries produce female hormones, such as estrogen, that are important in maintaining a woman's health. When the ovaries do not work properly, problems can develop. Unfortunately, there is no test that can detect ovarian failure early in its course. By the time premature ovarian failure is diagnosed in young women, two-thirds have already developed osteopenia (loss of some bone mass) and nearly one in ten have osteoporosis, a greater loss of bone mineral density that weakens bones and increases the risk of fractures.
Women with normal ovarian function ages 18 to 55 and postmenopausal women 60 years of age or older may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests and vaginal ultrasound examination. For the ultrasound study, a probe that emits sound waves is inserted into the vagina, and the sound waves are converted to form images of the ovaries. The procedure is done with an empty bladder and takes about 10 minutes. After this screening visit (Visit 1), those enrolled in the study will return to the NIH Clinical Center for the following additional procedures:
Read more
Visit 2-Will be scheduled between days 3 and 5 of the menstrual cycle (for women who are still menstruating). Participants will have blood tests to measure hormone levels and to check for pregnancy, and will have another transvaginal ultrasound examination. They will then receive an injection of a synthetic form of follicle stimulating hormone (FSH), a hormone the body makes normally.
Visits 3 and 4-Will be scheduled 24 and 36 hours after the FSH injection given during Visit 2 for collection of blood samples.
Visit 5-Will be scheduled 48 hours after the FSH injection for additional blood sampling and a final transvaginal ultrasound examination.
Read the detailed description
This is a pilot project to test the feasibility of developing an FSH stimulation test. There is a need for a sensitive and specific marker to detect ovarian insufficiency early in its course. FSH stimulates inhibin B production by the granulosa cells of the cohort of ovarian follicles; serum inhibin B in turn participates in the negative feedback loop regulating FSH secretion. This protocol is characterizing the normal FSH-stimulated serum inhibin B response to a single subcutaneous injection of 300 IU human recombinant FSH given on day 2 to 4 of the menstrual cycle. In preliminary analysis under this protocol we have demonstrated that FSH-stimulated serum inhibin B levels measured at 24 hours after injection is a more robust marker of functional ovarian age than ovarian follicle count by transvaginal ultrasound, basal serum Mullerian Inhibiting Substance (MIS) levels, or basal serum FSH levels. Multiple regression analysis has revealed that FSH-stimulated inhibin B, FSH-stimulated estradiol, and basal FSH contribute significantly to an ability to predict functional ovarian age (as approximated by chronological age). The resulting regression equation relating these three parameters with age has a correlation coefficient of 0.742 and a coefficient of determination of 0.551. The protocol is now evaluating the reproducibility of this test and the feasibility of generating normative data in young women between the ages of 18 and 25. The results of this study may define parameters that could lead to earlier diagnosis and treatment of premature ovarian insufficiency.
- Conditions
- Healthy, Premature Ovarian Failure
- Being tested
- Control, Drug: FSH
- Keywords
- Ovarian Failure, Ovary, Aging, Healthy Volunteer, Primary Ovarian Insufficiency(POI), Premature Menopause, Premature Ovarian Failure (POF)
- Medical subject headings
- Primary Ovarian Insufficiency, Menopause, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
No injection of FSH
Drug: FSHDrug
FSH Stimulation Test
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Control for FSH stimulation test Receives: Other: Control |
| Drug: FSH | Experimental | FSH Stimulation Test Receives: Drug: Drug: FSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels.
Measured: 24 hours
Secondary outcomes (1)
Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2000 (estimated)
- Study startAug 2000
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health Clinical Center (CC)
- Responsible party
- Principal investigator, Lawrence Nelson, M.D., National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006156
- Sponsor's protocol ID
- 000189
- Other IDs
- 00-CH-0189
- Status last verified
- Mar 2013
- First submitted
- 9 Aug 2000
- Last updated
- 16 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Anasti JN, Kalantaridou SN, Kimzey LM, Defensor RA, Nelson LM. Bone loss in young women with karyotypically normal spontaneous premature ovarian failure. Obstet Gynecol. 1998 Jan;91(1):12-5. doi: 10.1016/s0029-7844(97)00583-8.
PubMed 9464713Coulam CB, Adamson SC, Annegers JF. Incidence of premature ovarian failure. Obstet Gynecol. 1986 Apr;67(4):604-6.
PubMed 3960433Faddy MJ, Gosden RG. A model conforming the decline in follicle numbers to the age of menopause in women. Hum Reprod. 1996 Jul;11(7):1484-6. doi: 10.1093/oxfordjournals.humrep.a019422.
PubMed 8671489
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FSH-Stimulated Inhibin B as a Marker for Early Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT00006156
- Acronym / sponsor ID
- 000189
- Conditions
- Healthy, Premature Ovarian Failure
- Keywords
- Ovarian Failure, Ovary, Aging, Healthy Volunteer, Primary Ovarian Insufficiency(POI), Premature Menopause, Premature Ovarian Failure (POF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- National Institutes of Health Clinical Center (CC)
- Study start
- Aug 2000
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Aug 2000 (estimated)
- Results
- Posted 16 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to gain information about normal ovarian function that will be useful in developing a test for early detection of ovarian failure. The ovaries produce female hormones, such as estrogen, that are important in maintaining a woman's health. When the ovaries do not work properly, problems can develop. Unfortunately, there is no test that can detect ovarian failure early in its course. By the time premature ovarian failure is diagnosed in young women, two-thirds have already developed osteopenia (loss of some bone mass) and nearly one in ten have osteoporosis, a greater loss of bone mineral density that weakens bones and increases the risk of fractures.
Women with normal ovarian function ages 18 to 55 and postmenopausal women 60 years of age or older may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests and vaginal ultrasound examination. For the ultrasound study, a probe that emits sound waves is inserted into the vagina, and the sound waves are converted to form images of the ovaries. The procedure is done with an empty bladder and takes about 10 minutes. After this screening visit (Visit 1), those enrolled in the study will return to the NIH Clinical Center for the following additional procedures:
Visit 2-Will be scheduled between days 3 and 5 of the menstrual cycle (for women who are still menstruating). Participants will have blood tests to measure hormone levels and to check for pregnancy, and will have another transvaginal ultrasound examination. They will then receive an injection of a synthetic form of follicle stimulating hormone (FSH), a hormone the body makes normally.
Visits 3 and 4-Will be scheduled 24 and 36 hours after the FSH injection given during Visit 2 for collection of blood samples.
Visit 5-Will be scheduled 48 hours after the FSH injection for additional blood sampling and a final transvaginal ultrasound examination.
Detailed description
This is a pilot project to test the feasibility of developing an FSH stimulation test. There is a need for a sensitive and specific marker to detect ovarian insufficiency early in its course. FSH stimulates inhibin B production by the granulosa cells of the cohort of ovarian follicles; serum inhibin B in turn participates in the negative feedback loop regulating FSH secretion. This protocol is characterizing the normal FSH-stimulated serum inhibin B response to a single subcutaneous injection of 300 IU human recombinant FSH given on day 2 to 4 of the menstrual cycle. In preliminary analysis under this protocol we have demonstrated that FSH-stimulated serum inhibin B levels measured at 24 hours after injection is a more robust marker of functional ovarian age than ovarian follicle count by transvaginal ultrasound, basal serum Mullerian Inhibiting Substance (MIS) levels, or basal serum FSH levels. Multiple regression analysis has revealed that FSH-stimulated inhibin B, FSH-stimulated estradiol, and basal FSH contribute significantly to an ability to predict functional ovarian age (as approximated by chronological age). The resulting regression equation relating these three parameters with age has a correlation coefficient of 0.742 and a coefficient of determination of 0.551. The protocol is now evaluating the reproducibility of this test and the feasibility of generating normative data in young women between the ages of 18 and 25. The results of this study may define parameters that could lead to earlier diagnosis and treatment of premature ovarian insufficiency.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: ControlControl for FSH stimulation test |
| Drug: FSH | Experimental | Drug: Drug: FSHFSH Stimulation Test |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Women with normal ovarian function:
- Age 18 to 55.
- Normal body mass index (18-30 kg/m(2)).
- Normal menstrual cycles (between 25-35 days in length).
- Ovulatory serum progesterone concentrations (in excess of 6 ng/mL in the menstrual cycle just preceding the study cycle).
Key exclusion criteria (14 listed)
- History of infertility or infertility in a first degree relative.
- Acute or chronic disease.
- Menopause due to surgery, radiation, or chemotherapy.
- Current use of oral contraceptives or hormone replacement therapy, or use of these agents within the previous 3 months.
- Use within the previous three months of any medication known to affect the hypothalamic-pituitary-ovarian axis (including over-the-counter and alternative medicines).
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 |
|---|---|---|
| ControlNo injection of FSH | Other | Control |
| Drug: FSHFSH Stimulation Test | Drug | Drug: FSH |
Primary outcome
Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels.
Time frame: 24 hours
1 secondary outcome
Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9464713Anasti JN, Kalantaridou SN, Kimzey LM, Defensor RA, Nelson LM. Bone loss in young women with karyotypically normal spontaneous premature ovarian failure. Obstet Gynecol. 1998 Jan;91(1):12-5. doi: 10.1016/s0029-7844(97)00583-8.
- Background: PubMed 3960433Coulam CB, Adamson SC, Annegers JF. Incidence of premature ovarian failure. Obstet Gynecol. 1986 Apr;67(4):604-6.
- Background: PubMed 8671489Faddy MJ, Gosden RG. A model conforming the decline in follicle numbers to the age of menopause in women. Hum Reprod. 1996 Jul;11(7):1484-6. doi: 10.1093/oxfordjournals.humrep.a019422.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug: FSH in people with Healthy and Premature Ovarian Failure, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 15 inclusion and 14 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: finished, as of the sponsor's last update on 16 May 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?
Yes. Results are posted in the registry (first posted 16 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels. (time frame: 24 hours). 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 NCT00006156, 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 16 May 2013.