Evaluation of Women With Endocrine and Reproductive-Related Conditions

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001850
First received: November 3, 1999
Last updated: April 1, 2014
Last verified: March 2014
  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 With Endocrine and Reproductive-Related Conditions

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 700
Study Start Date: May 1999
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, 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.

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  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

Contacts
Contact: James H Segars, M.D. (301) 496-5800 segarsj@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
Investigators
Principal Investigator: James H Segars, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00001850     History of Changes
Other Study ID Numbers: 990103, 99-CH-0103
Study First Received: November 3, 1999
Last Updated: April 1, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Training
Reproduction
Infertility
Women's Health
Hormone

Additional relevant MeSH terms:
Endocrine System Diseases
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 31, 2014