Status:
UNKNOWN
Stem Cell Therapy and Growth Factor Ovarian in Vitro Activation
Lead Sponsor:
Forever Young d.o.o.
Collaborating Sponsors:
Medigroup Health System, Jevremova hospital
Saint James Hospital Malta
Conditions:
Menopause
Menopause Ovarian Failure
Eligibility:
FEMALE
25+ years
Phase:
PHASE1
PHASE2
Brief Summary
SEGOVA procedure includes - Stem cell therapy, G - Growth factor Platelet Plasma Rich therapy and in Vitro Activation of the ovaries.
Detailed Description
The current study seeks to demonstrate how integrative ovarian rejuvenation program called SEGOVA influence the restoration of hormone stability and increase in the number of follicles in ovarian fail...
Eligibility Criteria
Inclusion
- Confirmed informed consent, signature and date
- A woman over 25 years of age
- Primary or secondary amenorrhea for at least 3 months
- Hormone Anti Mullerian Hormone values \<\_0.42 ng / ML and Follicle stimulating hormone FSH\> 20 IU / L, and / or failure of previous attempts of assisted reproductive techniques due to limited ovarian response (less than 3 oocyte cells obtained).
- The proper karyotype 46, XX.
- Presence of at least one ovary
Exclusion
- Currently pregnancy or breastfeeding
- Presence of Sexually Transmitted Disease (STD positive)
- There is presence of acute infection (C Reactive Protein\>5)
- There is an anamnesis or evidence of existing gynecological malignancy
- The presence of adnexal masses indicating the need for further evaluation.
- It has a contraindication to laparoscopic surgery and / or general anesthesia
- Over the past two weeks, use of the following medicines: Oral or systemic corticosteroids, hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, herbal or botanical supplements with potential hormonal effects.
- Type I diabetes mellitus
- Known significant anemia (hemoglobin \<8 g / dL), Severe venous thrombosis and / or pulmonary embolism, Cerebrovascular disease, Presence of heart disease, Premature kidney disease (defined as urea in the blood\> 30 mg / dL or serum creatinine\> 1.6 mg / dL).
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04009473
Start Date
June 1 2019
End Date
December 1 2021
Last Update
August 6 2020
Active Locations (3)
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1
Saint James Hospital Malta
Sliema, Malta, SLM 3011
2
Re-medika Hospital
Skopje, Macedonia, North Macedonia, 1000
3
Medigroup Health System, Jevremova hospital
Belgrade, Serbia, 11000