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A study to compare the effect of metformin and myo-inositol with d-chiro-inositol on clinical, hormonal, and metabolic profile of infertile women with Polycystic Ovary Syndrome

Comparative Study of Metformin Versus Myo-Inositol with D-chiro-Inositol on the Clinical, Hormonal and Metabolic Profiles in infertile women with PCOS: An Open-Label Randomized Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083033
Enrollment
220
Registered
2025-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N970- Female infertility associated withanovulation Health Condition 2: E282- Polycystic ovarian syndrome

Interventions

Intervention1: myoinositol and d-chiro inositol: Study group will be treated with myoinositol and d-chiro inositol 2255 mg OD for 3 months Control Intervention1: metformin: The control group will be t

Sponsors

Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All infertile women with PCOS (Diagnosed according to Rotter-dam s criteria) attending the infertility clinic/OPD at Women and Children Hospital, JIPMER: 1)Age of the Women: between 21 to 35 years 2) Women with PCOS according to Rotterdam 2003 criteria 3) Willing for regular follow-up

Exclusion criteria

Exclusion criteria: A woman who is a known case of 1) Thyroid disorders 2) Congenital adrenal hyperplasia 3) Adrenal tumors 4) Cushing syndrome 5) Presence of any chronic diseases eg; diabetes mellitus, Chronic kidney disease, liver disease, etc. 6) Women who are allergic to metformin or inositols 7) Patient on metformin therapy 8) Women on steroid therapy or Oral contraceptive pills usage for within three months

Design outcomes

Primary

MeasureTime frame
To assess the effect of metformin and myoinositol+ d-chiro inositol on meta-bolic parameter - HOMA IR in infertile women with PCOS.Timepoint: from the day of entry to study and follow up visits at 4 weeks, 8 weeks and 12 weeks

Secondary

MeasureTime frame
To determine and compare the effects of Metformin and myoinositol with d-chiro inositol on - Clinical parameters, Hormonal parameters, Metabolic parameters, USG parameters, Quality of life- PCOSQOL scale Timepoint: from the day of entry to study and follow up visits at 4 weeks, 8 weeks and 12 weeks

Countries

India

Contacts

Public ContactDr Ann Sara Jacob

Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER)

drchitra@yahoo.com9488818644

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026