Premature Ovarian Failure Clinical Trial
— ADMSCOfficial title:
Autologous Adipose Derived Mesenchymal Stromal Cell Transplantation in Patients With Idiopathic or Drug Induced Premature Ovarian Failure
The primary ovarian insufficiency (premature ovarian failure, premature ovarian insufficiency, premature menopause) is a hypergonadotropic hypogonadism, that failure of the ovarian function in woman younger than 40 years. Fat derived stem cells are mainly mesenchymal stem cells and found to be effective treatment in joint and bone regeneration. We are planning to investigate the effectiveness of adipose stem cell on ovarian tissue regeneration for patients with premature ovarian failure.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | December 15, 2024 |
Est. primary completion date | October 15, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
Mongolia | Mongolian National University of Medical Science | Ulaanbaatar |
Lead Sponsor | Collaborator |
---|---|
Mongolian National University of Medical Sciences |
Mongolia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resumption of menses (12 months) | regular 25-45 day cycle menses, with 2-5 day bleeding. | 12 months | |
Primary | Improved clinical hormone levels. | FSH 4.7 to 21.5 mIU/mL (4.5 to 21.5 IU/L) | 12 months | |
Secondary | Achievement of pregnancy | A transvaginal ultrasound confirmation of gestational sac The hCG levels have reached between 1,000 - 2,000 mIU/mL. | 12 months |
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