Health Condition 1: 1- Obstetrics
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women between 20-40 years of age. 2.Presence of ovarian volume of more than 10 cm3 in at last one ovary assessed by transvaginal ultrasound (US). 3. The presence of micro polycystic ovaries (more than or equal to 12 follicles per ovary) in at least one ovary assessed by transvaginal ultrasound (US). 4. No hormonal treatment in the 6 months prior the study. 5. LH/follicle-stimulating hormone (FSH) more than 2.5. 6. Absence of any adrenal and/or other endocrine disease. 7. Women willing to undergo transvaginal ultrasound (US) for ovarian assessment. 8. Women able to understand the study requirements and follow other procedures required by the study protocol. 9. Must have the ability and willingness to sign an informed consent and to comply with all study procedures
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in volume of ovaries and follicle count assessed on transvaginal ultrasound scanTimepoint: Baseline, Week 8 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in BMITimepoint: Baseline, Week 4, Week 8, Week 12;Mean change in laboratory parameters (HbA1C)Timepoint: Baseline, Week 12;Mean change in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides)Timepoint: Baseline, Week 12;Mean change in liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parametersTimepoint: Baseline, Week 12;Mean change in perceived stress scale scoreTimepoint: Baseline, Week 4, Week 8, Week 12;Mean change in renal (serum creatinine, blood urea nitrogen) parametersTimepoint: Baseline, Week 12;Mean change in serum hormones (Sr. Estradiol- E2, Follicle-Stimulating Hormone, Luteinizing Hormone, Progesterone, Testosterone, Dehydroepiandrosterone Sulfate)Timepoint: Baseline, Week 12;Mean change in serum insulin by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)Timepoint: Baseline, Week 12;Mean change in Thyroid (T3, T4, TSH) parametersTimepoint: Baseline, Week 12;Proportion of patients experiencing Treatment-Emergent Adverse Events (TEAEs)Timepoint: Baseline, Week 4, Week 8, Week 12;Proportion of patients experiencing Treatment-Emergent Serious Adverse Events (TESAEs)Timepoint: Baseline, Week 4, Week 8, Week 12 | — |
Countries
India
Contacts
Public ContactDr Yashodhara Mhatre
Director
Outcome results
None listed