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Evaluation of Women With Endocrine and Reproductive-Related Conditions

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ClinicalTrials.gov Identifier: NCT00001850
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )

Study Description
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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>


Condition or disease
Endocrine Disease Infertility Leiomyoma Endometriosis Fibroids

Detailed Description:
The specific objective of this protocol is to gain knowledge and collect data in order to allow for hypothesis generation in future research as well as give NICHD investigators and trainees hands on experience related to the diagnoses, management, treatment and follow-up of reproductive endocrine disorders. Such disorders include but are not limited to Polycystic ovarian syndrome, Endometriosis, Primary ovarian insufficiency, Recurrent pregnancy loss, Primary amenorrhea and Infertility. This information will be taken from standard medical care/procedures and follow up of patients and healthy volunteers. It allows investigation into the problems of these patients for the purpose of furthering general knowledge and teaching.
Study Design
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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Women and Men With Endocrine and Reproductive-Related Conditions
Actual Study Start Date : May 10, 1999
Groups and Cohorts
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Group/Cohort
Children
with reproductive disorders
Men
with reproductive disorders
Woman
with reproductive disorders


Outcome Measures
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Primary Outcome Measures :
  1. To provide a mechanism for reproductive endocrine fellows and staff to evaluate woman with medical conditions of interest for fellow training and clinical training and education. [ Time Frame: 11/30/2025 ]
    To provide a mechanism for reproductive endocrine fellows and staff to evaluate woman with medical conditions of interest for fellow training and clinical training and education.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 1-85 with reproductive disorders
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001850


Contacts
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Contact: Aliza Y Kramer, R.N. (301) 496-5800 aliza.kramer@nih.gov
Contact: Alan H DeCherney, M.D. (301) 402-2141 decherna@mail.nih.gov

Locations
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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 Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Alan H DeCherney, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
More Information
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Additional Information:

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Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00001850    
Other Study ID Numbers: 990103
99-CH-0103
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: February 15, 2022
Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
Reproductive Surgery
Infertility
Hormone Replacement Therapy
 GATA 2
Sickle Cell
Natural History
Additional relevant MeSH terms:
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Leiomyoma
Infertility
Endometriosis
Endocrine System Diseases
 Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms