Rejuvenation of Premature Ovarian Failure With Stem Cells (NCT02696889) | Clinical Trial Compass
CompletedNot Applicable
Rejuvenation of Premature Ovarian Failure With Stem Cells
United States3 participantsStarted 2016-02-06
Plain-language summary
The ROSE-1 study is designed to determine the efficacy of bone marrow derived stem cell therapy on ovarian function recovery in subjects with idiopathic and other types of premature or primary ovarian failure (POF or POI) and low ovarian reserves.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria
* Able to understand and communicate in English language
* Signed and dated informed consent
* Female over the age of 18
* Diagnosis of premature ovarian insufficiency: At least two menopausal FSH levels (≥ 40 IU/L) and/or Primary or secondary amenorrhea at least for 3-6 months OR Diagnosis of low ovarian reserve defined as: AMH \< \_0.42 ng/ML \& FSH \>20 IU/L, and/or failure of prior attempts of assisted reproductive techniques due to limited ovarian response (poor responder).
* Normal karyotype 46, XX.
* Presence of at least one ovary
* Acceptable uterine anatomy (by any clinically and/or imaging acceptable methods)
* Normal thyroid function as evidence by normal serum Thyroid Stimulating Hormone (TSH) levels.
* Agree to report any pregnancy to the research staff immediately.
* Willing and able to comply with study requirements and follow up instructions.
* No other causes of female infertility in the subject
If subject is planning to pursue pregnancy: Presence of at least unilateral tubal patency (with any clinically acceptable methods).
Exclusion Criteria
* Unable to understand and communicate in English language
* Currently pregnant or breast-feeding
* Has a history of, or evidence of current gynecologic malignancy within the past three years
* Presence of adnexal masses indicating the need for further evaluation
* Major mental health disorder that precludes participation in the study
* Active substance abuse or dependence
* Unfit or unwilling to …