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To compare the efficacy of metformin versus metformin plus myoinositol in infertile PCOS women undergoing ovulation induction plus intrauterine insemination.

To study the metabolic and hormonal effects of metformin versus metformin plus myoinositol in PCOS women undergoing ovulation induction plus IUI and infertility outcomes - NIL

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/009021
Enrollment
80
Registered
2017-07-11
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: null- PCOS with infertility

Interventions

Intervention1: METFORMIN PLUS MYOINOSITOL: Tablet Metformin 500mg + Myoinositol 600mg three times a day per oral for 6 months Control Intervention1: METFORMIN: Tablet METFORMIN 500 mg thrice a day per

Sponsors

AIIMS
Lead Sponsor

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 hystosalpingography / laparoscopy

Exclusion criteria

Exclusion criteria: •Patient already on other drugs for treatment of PCOS like OCPs •Deranged kidney or liver function tests •Uncontrolled Thyroid disorders •Known hypersensitivity to myoinositol or metformin •Moderate to severe male factor infertility •Women with any other endocrinological disorders.

Design outcomes

Primary

MeasureTime frame
To compare the effect of Metformin vs Metformin plus Myoinositol on pregnancy rate in PCOS women undergoing ovulation induction and IUITimepoint: 6 months

Secondary

MeasureTime frame
To compare the effect of Metformin vs Metformin plus Myoinositol on: â?¢ Clinical parameters in women with PCOS â?¢ Biochemical parameters in women with PCOS â?¢ Ovulation rate â?¢ Ongoing pregnancy rate â?¢ Ovarian hyperstimulation syndrome â?¢ Number of abortions and multiple pregnancies Timepoint: 6 months

Countries

India

Contacts

Public ContactAnisha Agrawal

All India Institute Of Medical Sciences

reetamahey52@gmail.com9818447845

Outcome results

None listed

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