Infertility Clinical Trial
Official title:
Oogonial Stem Cell Isolation in Ovarian Insufficiency Patients
Verified date | September 21, 2017 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- Primary ovarian insufficiency (POI) is a condition that affects ovary function. It means
that the ovaries are not able to function at a level appropriate for a woman's age.
Previously, it was thought that women had only a fixed number of eggs that were lost each
month until none were left at menopause. However, recently, stem cells have been found in the
ovaries of adult women. These stem cells may be able to make new eggs. Studying these cells
may help women with POI in the future. Researchers want to collect ovarian tissue from women
with POI to investigate ovarian stem cells.
Objectives:
- To collect ovarian tissue from women with primary ovarian insufficiency.
Eligibility:
- Women between 18 and 50 years of age with primary ovarian insufficiency.
Design:
- Participants will be screened with a physical exam and medical history. They will also
have a full gynecological exam. They will provide blood and urine samples.
- Participants will donate ovarian tissue for study. It will be collected through
outpatient surgery. The surgery will take either half of an ovary or a full ovary.
- Treatment will not be provided as part of this study.
Status | Completed |
Enrollment | 11 |
Est. completion date | September 21, 2017 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
- INCLUSION CRITERIA: Subject is able to give consent/assent to participate in the protocol. Listed below are acceptable medical conditions for inclusion in this protocol: - Females older than 18 years with POI, POF, or DOR, undergoing ovarian biopsy by laparoscopy or clinically indicated abdominal surgery that provides access to the ovaries - Clinical etiologies of POI may include, but are not limited to, idiopathic, autoimmune, chemotherapy related, or Turner s syndrome - Subjects must have a diagnosis of premature ovarian failure or diminished ovarian reserve as defined by both: 1. Early follicular phase FSH >15 IU/L 2. AMH <0.16 ng/ml or below the level of detection for the assay used - Females older than 18 years, with or without POI or POF, undergoing clinically indicated ovarian surgery EXCLUSION CRITERIA: Unable to comprehend the investigational nature of the protocol participation Positive pregnancy test Anticoagulation or known coagulopathy Ovarian cancer History of a previous laparoscopy or laparotomy revealing abdominal adhesions that would preclude ovarian biopsy Previous bowel surgery. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Anasti JN, Kimzey LM, Defensor RA, White B, Nelson LM. A controlled study of danazol for the treatment of karyotypically normal spontaneous premature ovarian failure. Fertil Steril. 1994 Oct;62(4):726-30. — View Citation
Nelson LM, Kimzey LM, White BJ, Merriam GR. Gonadotropin suppression for the treatment of karyotypically normal spontaneous premature ovarian failure: a controlled trial. Fertil Steril. 1992 Jan;57(1):50-5. — View Citation
van Kasteren YM, Schoemaker J. Premature ovarian failure: a systematic review on therapeutic interventions to restore ovarian function and achieve pregnancy. Hum Reprod Update. 1999 Sep-Oct;5(5):483-92. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The immediate aim of this protocol is to characterize oogonial stem cells in patients with primary ovarian insufficiency and diminished ovarian reserve. |
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