Endocrine DiseaseNCT00001850
Evaluation of Women With Endocrine and Reproductive-Related Conditions
An observational study of Endocrine Disease and Infertility, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
This study was designed to allow inpatient and outpatient evaluation of women with a variety of reproductive and endocrine-related disorders for purposes of research and physician education. The evaluations may include ultrasound examinations, blood, saliva, and/or urine samples. Read more about this study
- Who is it for?
- Ages 1 year to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrine Disease, Infertility, Leiomyoma
- How many people
- 833 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 1999to 23 May 2023
- Phase
- Observational
- 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 1 year to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients aged 1-85 with reproductive disorders
Who may be able to join
- Subjects aged 1-85 with reproductive endocrine related conditions.
- Young women, women of reproductive age, and older women are the focus of this protocol.
- Girls with reproductive disorders under the age of 18 will be studied and their assent will be obtained if possible along with the consent of their parent/guardian.
- Reproductive disorders of men will be included.
Who cannot join
- Pregnant women over 23 weeks will be excluded, since there are no on-campus prenatal or neonatal facilities. If we see patients in consultation after 23 weeks, as is our practice, we will provide a report to the referring PI on that protocol as well as the patient's personal obstetrician. We do not provide long term obstetrical care.
- Patients specifically requesting in vitro fertilization will not be considered candidates and will not be seen under this protocol. These patients may be seen for a consultation, but will be referred for these services outside of the NIH.
- Pregnant patients requiring fetal surgery will be excluded since there are no on-campus neonatal facilities.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of Women and Men With Endocrine and Reproductive-Related Conditions
This study was designed to allow inpatient and outpatient evaluation of women with a variety of reproductive and endocrine-related disorders for purposes of research and physician education.
The evaluations may include ultrasound examinations, blood, saliva, and/or urine samples. In some cases, specific laboratory or X-ray studies will be performed to confirm the diagnosis or assist in the treatment of the patient. These additional tests will be conducted within the guidelines of current gynecologic practice. In some cases, the patient will receive medical or surgical treatment for their disorder.
The purpose of this study is to provide an opportunity for physicians to evaluate women with medical conditions of reproduction. These evaluations and treatments will support clinical training and research for the accredited training program in reproductive endocrinology at the National Institute of Child Health and Human Development (NICHD).<TAB>
Read the detailed description
The specific objective of this protocol is to gain knowledge and collect data in order to allow for hypothesis generation in future research as well as give NICHD investigators and trainees hands on experience related to the diagnoses, management, treatment and follow-up of reproductive endocrine disorders. Such disorders include but are not limited to Polycystic ovarian syndrome, Endometriosis, Primary ovarian insufficiency, Recurrent pregnancy loss, Primary amenorrhea and Infertility. This information will be taken from standard medical care/procedures and follow up of patients and healthy volunteers. It allows investigation into the problems of these patients for the purpose of furthering general knowledge and teaching.
- Conditions
- Endocrine Disease, Infertility, Leiomyoma, Endometriosis, Fibroids
- Keywords
- Reproductive Surgery, Infertility, Hormone Replacement Therapy, GATA 2, Sickle Cell, Natural History
- Medical subject headings
- Endocrine System Diseases, Infertility, Leiomyoma, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | with reproductive disorders | |
| Men | with reproductive disorders | |
| Woman | with reproductive disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide a mechanism for reproductive endocrine fellows and staff to evaluate woman with medical conditions of interest for fellow training and clinical training and education.
To provide a mechanism for reproductive endocrine fellows and staff to evaluate woman with medical conditions of interest for fellow training and clinical training and education.
Measured: 11/30/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start10 May 1999
- Primary completion23 May 2023
- Study completion23 May 2023
Why it stopped: Terminated at the direction of the NIH IRBO.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 833 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
- Responsible party
- Sponsor
- Investigators
- Alan H DeCherney, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001850
- Sponsor's protocol ID
- 990103
- Other IDs
- 99-CH-0103
- Status last verified
- May 2023
- First submitted
- 3 Nov 1999
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Women and Men With Endocrine and Reproductive-Related Conditions
- ClinicalTrials.gov ID
- NCT00001850
- Acronym / sponsor ID
- 990103
- Conditions
- Endocrine Disease, Infertility, Leiomyoma, Endometriosis, Fibroids
- Keywords
- Reproductive Surgery, Infertility, Hormone Replacement Therapy, GATA 2, Sickle Cell, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated at the direction of the NIH IRBO.
- Enrolment
- 833 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 10 May 1999 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 4 Nov 1999 (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.
This study was designed to allow inpatient and outpatient evaluation of women with a variety of reproductive and endocrine-related disorders for purposes of research and physician education.
The evaluations may include ultrasound examinations, blood, saliva, and/or urine samples. In some cases, specific laboratory or X-ray studies will be performed to confirm the diagnosis or assist in the treatment of the patient. These additional tests will be conducted within the guidelines of current gynecologic practice. In some cases, the patient will receive medical or surgical treatment for their disorder.
The purpose of this study is to provide an opportunity for physicians to evaluate women with medical conditions of reproduction. These evaluations and treatments will support clinical training and research for the accredited training program in reproductive endocrinology at the National Institute of Child Health and Human Development (NICHD).<TAB>
Detailed description
The specific objective of this protocol is to gain knowledge and collect data in order to allow for hypothesis generation in future research as well as give NICHD investigators and trainees hands on experience related to the diagnoses, management, treatment and follow-up of reproductive endocrine disorders. Such disorders include but are not limited to Polycystic ovarian syndrome, Endometriosis, Primary ovarian insufficiency, Recurrent pregnancy loss, Primary amenorrhea and Infertility. This information will be taken from standard medical care/procedures and follow up of patients and healthy volunteers. It allows investigation into the problems of these patients for the purpose of furthering general knowledge and teaching.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children | – | –with reproductive disorders |
| Men | – | –with reproductive disorders |
| Woman | – | –with reproductive disorders |
Who may qualify
- Ages
- 1 year to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 1-85 with reproductive disorders
Key inclusion criteria (4 listed)
- Subjects aged 1-85 with reproductive endocrine related conditions.
- Young women, women of reproductive age, and older women are the focus of this protocol.
- Girls with reproductive disorders under the age of 18 will be studied and their assent will be obtained if possible along with the consent of their parent/guardian.
- Reproductive disorders of men will be included.
Key exclusion criteria (3 listed)
- Pregnant women over 23 weeks will be excluded, since there are no on-campus prenatal or neonatal facilities. If we see patients in consultation after 23 weeks, as is our practice, we will provide a report to the referring PI on that protocol as well as the patient's personal obstetrician. We do not provide long term obstetrical care.
- Patients specifically requesting in vitro fertilization will not be considered candidates and will not be seen under this protocol. These patients may be seen for a consultation, but will be referred for these services outside of the NIH.
- Pregnant patients requiring fetal surgery will be excluded since there are no on-campus neonatal facilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To provide a mechanism for reproductive endocrine fellows and staff to evaluate woman with medical conditions of interest for fellow training and clinical training and education.
Time frame: 11/30/2025
To provide a mechanism for reproductive endocrine fellows and staff to evaluate woman with medical conditions of interest for fellow training and clinical training and education.
Results and safety
The study was stopped early (reason given: Terminated at the direction of the NIH IRBO.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Alan H DeCherney, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine Disease and Infertility, 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 25 May 2023. 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?
The study was stopped early (reason given: Terminated at the direction of the NIH IRBO.). 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?
To provide a mechanism for reproductive endocrine fellows and staff to evaluate woman with medical conditions of interest for fellow training and clinical training and education. (time frame: 11/30/2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2023.