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Evaluation of Women With Endocrine and Reproductive-Related Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001850
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : October 4, 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) )

Tracking Information
First Submitted Date November 3, 1999
First Posted Date November 4, 1999
Last Update Posted Date October 4, 2022
Actual Study Start Date May 10, 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: January 29, 2020)
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients aged 1-85 with reproductive disorders
Condition
  • Endocrine Disease
  • Infertility
  • Leiomyoma
  • Endometriosis
  • Fibroids
Intervention Not Provided
Study Groups/Cohorts
  • Children
    with reproductive disorders
  • Men
    with reproductive disorders
  • Woman
    with reproductive disorders
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 85 Years   (Child, Adult, Older Adult)
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) 594-5494 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
Current Responsible Party National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
Original Responsible Party Not Provided
Current Study Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Original Study Sponsor Same as current
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 February 15, 2022