Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
NCT ID: NCT05279768
Last Updated: 2022-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2022-09-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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WJ-MSCs
Patients will be given tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (growth medium) for 30 days.
UC-MSCs
Treatment with tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (growth medium) for 30 days.
Secretomes
Patients will be given tablet (placebo) once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.
Secretomes
Treatment with tablet (placebo) once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.
WJ-MSCs and Secretomes
Patients will be given tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.
UC-MSCs and Secretomes
Treatment with tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.
Control
Patients will be given Metformin once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (growth medium) for 30 days.
Control
Treatment with Metformin once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (growth medium) for 30 days.
Interventions
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UC-MSCs
Treatment with tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (growth medium) for 30 days.
Secretomes
Treatment with tablet (placebo) once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.
UC-MSCs and Secretomes
Treatment with tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.
Control
Treatment with Metformin once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (growth medium) for 30 days.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
20 Years
40 Years
FEMALE
No
Sponsors
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PT. Prodia Stem Cell Indonesia
INDUSTRY
Responsible Party
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Principal Investigators
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Rima Haifa, B.Sc
Role: STUDY_CHAIR
Prodia Stem Cell Indonesia
Locations
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PT Prodia StemCell Indonesia
Jakarta, , Indonesia
Countries
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Central Contacts
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Other Identifiers
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CT/PCOS/PSI/2022
Identifier Type: -
Identifier Source: org_study_id
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