Bethesda, Maryland 20892


Purpose:

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>


Study summary:

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 and the collection of 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 teaching and clinical training.


Criteria:

- 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.


NCT ID:

NCT00001850


Primary Contact:

Principal Investigator
Alan H DeCherney, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Aliza Y Kramer, R.N.
Phone: (301) 496-5800
Email: aliza.kramer@nih.gov


Backup Contact:

Email: decherna@mail.nih.gov
Alan H DeCherney, M.D.
Phone: (301) 496-5800


Location Contact:

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: ClinicalTrials.gov

Date Processed: September 23, 2017

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