To compare the effects of two different regimens for treatment of infertility in infertile PCOS women

TO compare two drug combinations to improve pregnancy rate in infertile women with PCOS - To compare the effect of Metformin plus Myoinositol versus Myoinositol alone in terms of clinical pregnancy rate in infertile PCOS women

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/12/022258

Enrollment

100

Registered

2019-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome Health Condition 2: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Myoinositol: 2 grams twice a day for 3 months Intervention2: Metformin and Myo-inositol: Tab Metformin 500mg three times a day and Tab Myoinositol 2g per day for 6 months Control Inter

Eligibility

Inclusion criteria

Inclusion criteria: 1. Infertile women with PCOS(according to Rotterdam criteria) 2.Women 20-38 years of age 3.BMI 4. Willing to participate in study and follow up. 5.Bilateral patent tubes on hysterosalpingography/laparoscopy.

Exclusion criteria

Exclusion criteria: 1.Patients already on other drugs for treatment of PCOS like OCPs. 2.Deranged kidney or liver function tests 3.Uncontrolled Thyroid disorders/impaired GTT/Diabetes mellitus. 4.Known hypersensitivity to Myoinositol or Metformin. 5.Moderate to severe male factor infertility. 6.Women with ny other endocrinological disorders.

Design outcomes

Primary

Measure	Time frame
Total number of women attaining clinical pregnancy in either group(confirmed by USG)Timepoint: 6 months	—

Secondary

Measure	Time frame
Improvement in clinical,metabolic and hormonal parameters in PCOS women. Timepoint: 3 months;Ongoing pregnancy rate(POG12 wks) Timepoint: 6 months;Ovulation rate. Timepoint: 3 months;Total number of abortions occurring in present pregnancy. Timepoint: 6 months;Total number of ectopic or multiple pregnancies.Timepoint: 6 months;Total number of OHSS cases. Timepoint: 6 months	—

Countries

India

Contacts

Public ContactDr Reeta Mahey

All India Institute Of Medical Sciences

reetamahey52@gmail.com9818447845

Outcome results

None listed

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