Evaluation of Women With Endocrine and Reproductive-Related Conditions

  • STATUS
    Recruiting
  • participants needed
    900
  • sponsor
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Updated on 19 September 2021

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>

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.

Details
Condition Endocrine disorder, Endometriosis, Female Genital Diseases, Infertility, UTERINE FIBROID, Gynecological Infections, Uterine Fibroids, Leiomyomas, leiomyoma, endocrinopathy, endocrine disorders, endocrine disease, endocrine diseases, fibroids, sterility, unable to conceive
Clinical Study IdentifierNCT00001850
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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