Evaluation of Women With Endocrine and Reproductive-Related Conditions (NCT00001850) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of Women With Endocrine and Reproductive-Related Conditions
Stopped: Terminated at the direction of the NIH IRBO.
United States833 participantsStarted 1999-05-10
Plain-language 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. 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\>
Who can participate
Age range
1 Year – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 11/30/2025
Trial details
NCT IDNCT00001850
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)