Evaluation of Women With Endocrine and Reproductive-Related Conditions
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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 |
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Recruitment Status :
Recruiting
First Posted : November 4, 1999
Last Update Posted : November 25, 2019
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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 |
| 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 6, 1999 |
| Group/Cohort |
|---|
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Children
with reproductive disorders
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Men
with reproductive disorders
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Woman
with reproductive disorders
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- 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: six years ]
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, Learn About Clinical Studies.
| 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 |
- 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.
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
| 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 |
| 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 | |
| Principal Investigator: | Alan H DeCherney, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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 |
| First Posted: | November 4, 1999 Key Record Dates |
| Last Update Posted: | November 25, 2019 |
| Last Verified: | February 15, 2019 |
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Training Reproduction Infertility Women's Health Hormone |
Hormone Replacement Therapy Graft Vs Host Disease GATA 2 Sickle Cell |
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Leiomyoma Infertility Endometriosis Endocrine System Diseases Genital Diseases, Male Genital Diseases, Female Neoplasms, Muscle Tissue |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |