Status:
UNKNOWN
Autologous ADMSC Transplantation in Patients With POI
Lead Sponsor:
Mongolian National University of Medical Sciences
Conditions:
Premature Ovarian Failure
Eligibility:
FEMALE
20-40 years
Phase:
PHASE1
Brief Summary
The primary ovarian insufficiency (premature ovarian failure, premature ovarian insufficiency, premature menopause) is a hypergonadotropic hypogonadism, that failure of the ovarian function in woman y...
Detailed Description
The primary ovarian insufficiency (premature ovarian failure, premature ovarian insufficiency, premature menopause) is a hypergonadotropic hypogonadism, that failure of the ovarian function in woman y...
Eligibility Criteria
Inclusion
- 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).
- 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.
Exclusion
- 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
- 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.
- 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).
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06132542
Start Date
January 15 2024
End Date
December 15 2024
Last Update
November 15 2023
Active Locations (1)
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1
Mongolian National University of Medical Science
Ulaanbaatar, Mongolia