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Evaluation of Women With Endocrine and Reproductive-Related Conditions
This study is currently recruiting participants.
Verified February 23, 2017 by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00001850
First received: November 3, 1999
Last updated: June 30, 2017
Last verified: February 23, 2017
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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>
| Condition |
|---|
| Endocrine Disease Infertility |
| Study Type: | Observational |
| Official Title: | Evaluation of Women and Men With Endocrine and Reproductive-Related Conditions |
Further study details as provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
| Estimated Enrollment: | 900 |
| Study Start Date: | May 4, 1999 |
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.
Eligibility| Ages Eligible for Study: | 1 Year to 80 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001850
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001850
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 |
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Alan H DeCherney, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
More Information
Additional Information:
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00001850 History of Changes |
| Other Study ID Numbers: |
990103 99-CH-0103 |
| Study First Received: | November 3, 1999 |
| Last Updated: | June 30, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
|
Training Reproduction Infertility Women's Health Hormone |
Additional relevant MeSH terms:
|
Infertility Endocrine System Diseases Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on September 21, 2017