Evaluation of Women With Endocrine and Reproductive-Related Conditions

Tracking Information
First Submitted Date	November 3, 1999
First Posted Date	November 4, 1999
Last Update Posted Date	May 9, 2018
Study Start Date	May 5, 1999
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00001850 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Evaluation of Women With Endocrine and Reproductive-Related Conditions
Official Title	Evaluation of Women and Men With Endocrine and Reproductive-Related Conditions
Brief 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>
Detailed Description	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.
Study Type	Observational
Study Design	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	Endocrine Disease; Infertility
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Recruiting
Estimated Enrollment; (submitted: February 19, 2016)	900
Original Enrollment; (submitted: June 23, 2005)	150
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	1 Year to 80 Years (Child, Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts	Contact: Aliza Y Kramer, R.N. (301) 496-5800 aliza.kramer@nih.gov Contact: Alan H DeCherney, M.D. (301) 496-5800 decherna@mail.nih.gov
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00001850
Other Study ID Numbers	990103; 99-CH-0103
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
Study Sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators	Not Provided
Investigators	Principal Investigator: Alan H DeCherney, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
PRS Account	National Institutes of Health Clinical Center (CC)
Verification Date	May 2, 2018