NIH Clinical Research Studies

Protocol Number: 99-CH-0103

Active Accrual, Protocols Recruiting New Patients

Title:
Evaluation of Women With Endocrine and Reproductive-Related Conditions
Number:
99-CH-0103
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).

Sponsoring Institute:
National Institute of Child Health and Human Development (NICHD)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Female
Referral Letter Required: No
Population Exclusion(s): Male

Eligibility Criteria:
INCLUSION CRITERIA and EXCLUSION 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 pedigree analysis. 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.

Special Instructions: Currently Not Provided
Keywords:
Training
Reproduction
Infertility
Women's Health
Hormone
Recruitment Keywords:
None
Conditions:
Endocrine Disease
Infertility
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations: Not Provided

Active Accrual, Protocols Recruiting New Patients

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