View Clinical Trial (Medical Research Study)
Evaluation of Women With Endocrine and Reproductive-Related Conditions
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Endocrine Disease - Infertility |
| Purpose: |
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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).
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| Study Summary: |
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This protocol is 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 in our accredited reproductive endocrine training program. The
evaluations may include ultrasound examinations, blood, saliva, and/or urine samples. In
some cases, laboratory or radiologic studies will be performed to confirm the diagnosis or
to aid in the management of the patient, as would be done in current gynecologic practice.
In some cases, the patient will receive medical or surgical treatment for their disorder.
The purpose of these evaluations or treatments will be to support our clinical training
and/or research mission. In particular, this protocol is intended to provide a mechanism
for reproductive endocrine fellows and staff to evaluate women with medical conditions of
interest for fellow training and clinical training.
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| Criteria: |
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- ELIGIBILITY CRITERIA:
Patients aged 15-80 with reproductive endocrine-related conditions will be eligible for
this protocol. In general, young women, women of reproductive age, and older women are the
focus of this protocol. The selection of the patients most appropriate for research or
teaching purposes will be made by the investigators. Since research and training are the
primary objectives, the final decision regarding admission to the protocol will rest with
the principal investigator of the protocol. Although not the primary focus of the
protocol, in rare cases girls with reproductive disorders may be evaluated under this
protocol. Children admitted to the protocol will be seen in consultation with a
pediatrician. Girls under age 18 will be studied only with their assent and the consent of
their parents. Patients in the second and third trimester of pregnancy will be excluded,
since there are no on-campus prenatal or neonatal facilities. Women in the first trimester
of pregnancy will not be summarily excluded, but may participate, providing evaluation
poses no threat to their fetus. Reproductive disorders of men are not the focus of this
protocol, and men will only be studied as needed for evaluation of the female partner. At
present, the NIH does not have suitable laboratory facilities and staff for the evaluation
of male reproductive disorders.
In general, only reproductive disorders of rarity or specific interest of the
investigators will be studied. Common disorders, or patients needing in vitro
fertilization will not be considered candidates for the study, since the creation of human
embryos for the purpose of research is against federal guidelines for human research.
Patients specifically requesting assisted reproduction (in vitro fertilization and
intracytoplasmic sperm injection) will not be considered candidates for study.
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| NCT ID: |
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NCT00001850 |
| Primary Contact: |
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Principal Investigator
Alicia Y Armstrong, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Alicia Y Armstrong, M.D.
Phone: (301) 496-5800
Email: armstroa@mail.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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