Status:
UNKNOWN
Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
Lead Sponsor:
PT. Prodia Stem Cell Indonesia
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
20-40 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to investigating the effect of Umbilical Cord Mesenchymal Stem Cell (UC-MSCs) and secretomes to insulin resistance in Polycystic Ovary Syndrome (PCOS) patients. This study...
Detailed Description
The investigator hypothesized that PCOS patients with insulin resistance given combination of UC-MSCs and secretomes can improve their clinical and laboratory insulin resistance, haid ovulatory cycle ...
Eligibility Criteria
Inclusion
- PCOS patients with insulin resistance based on Rotterdam Consensus criteria, i.e. menstrual disorders (oligomenorhea/ amennorhea)
- Patients must have hiperandrogenemia clinical and laboratory proof (Ferriman Gallwey score \>8)
- Patients with Free Androgen Index (FAI) \>4 and ovary polycystic from USG transvaginal
- Patients with Homeostatic (HOMA) IR score ≥ 1.7
Exclusion
- Patients who are allergic to component of WJ-MSC or Secretome.
- Patients who are not currently on hormon treatment of other resistance treatment.
- Refusing or not participating in part / all of the research process.
- Patients with positive diagnosis of hepatitis A,B,C, and HIV
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05279768
Start Date
September 1 2022
End Date
December 1 2023
Last Update
September 26 2022
Active Locations (1)
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1
PT Prodia StemCell Indonesia
Jakarta, Indonesia