Rejuvenation of Premature Ovarian Failure With Stem Cells (ROSE-1)
Primary Ovarian Insufficiency, Low Ovarian Reserve, Premature Ovarian Failure
About this trial
This is an interventional treatment trial for Primary Ovarian Insufficiency focused on measuring Infertility, Premature Ovarian Failure, Stem Cells, Amenorrhea, Low Ovarian Reserve, Ovarian Insufficiency, Premature menopause, Premature Ovarian Insufficiency
Eligibility Criteria
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 undergo laparoscopy; has contraindication to laparoscopic surgery and/or general anesthesia
- Current or recent (within the past 2 weeks) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, herbal or botanical supplements with possible hormonal effects. Washout will be allowed.
- Medical conditions that are contraindicated in pregnancy
- Type I or Type II diabetes mellitus, or if receiving antidiabetic medications
- Known significant anemia (Hemoglobin <8 g/dL).
- Untreated deep venous thrombosis, and/or pulmonary embolus
- Untreated cerebrovascular disease
- Known heart disease (New York Heart Association Class II or higher).
- Known Liver disease (defined as Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)>2 times normal, or total bilirubin >2.5 mg/dL).
- Known Renal disease (defined as Blood urea nitrogen (BUN)>30 mg/dL or serum creatinine > 1.6 mg/dL).
Sites / Locations
- University of Illinois at Chicago
Arms of the Study
Arm 1
Experimental
ROSE-1 Protocol
Patients with POF, POI or Low Ovarian Reserve choosing to enroll will be provided informed consent for Rejuvenation of Premature Ovarian Failure With Stem Cells (ROSE-1). They will undergo diagnosis and screening confirming diagnosis including History and Physical Exams, Labs and Diagnostic Procedures. Following final approval and under anesthesia, bone marrow aspiration with separation of the bone marrow derived stem cell fraction will be performed. Diagnostic laparoscopy will allow for assessment of pelvic anatomy and subsequent injection of the bone marrow derived stem cells into the right ovary.