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

Not Applicable

Active, not recruiting

Conditions: Polycystic ovarian syndrome, (2) ICD-10 Condition: E282||Polycystic ovarian syndrome,

Brief Summary: Insulin resistance is one of the main component of polycystic ovary syndrome. Metformin is an insulin sensitiser being used along with ovulation induction to improve pregnancy rate in infertile PCOS women. But main disadvantage of Metfomrin is gastro-intestinal side effects. Inositol have been recently studied in infertile PCOS women and have been seen to improve insulin resistance. Both Metformin and Myoinositol improve insulin resistance but through different mechanisms. The present study is being conducted to evaluate whether combination of Metformin and Myo-inositol will have better effect in terms of clinical pregnancy rate as compare to Myoinositol alone in infertile PCOS women.

In initial 3 months of study, only the drugs will be given and couples will be advised to try for natural conception. After 3 months, patients who will not conceive, will be given Letrozole with or without gonadotrophin for ovulation induction for 3 cycles.

Main primary outcome will be clinical pregnancy rate.

Recruitment & Eligibility

Inclusion Criteria

Infertile women with PCOS(according to Rotterdam criteria) 2.Women 20-38 years of age 3.BMI<30 kg/m2 4.
Willing to participate in study and follow up.
5.Bilateral patent tubes on hysterosalpingography/laparoscopy.

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.

Primary Outcome Measures

Name	Time	Method
Total number of women attaining clinical pregnancy in either group(confirmed by USG)	6 months

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate(POG12 wks)
Total number of ectopic or multiple pregnancies.	6 months
Ovulation rate.
Total number of OHSS cases.
Total number of abortions occurring in present pregnancy.
Improvement in clinical,metabolic and hormonal parameters in PCOS women.

Locations (1): Outpatient Department,Department of Obstetrics and Gynecology,AIIMS
🇮🇳
Delhi, DELHI, India
Outpatient Department,Department of Obstetrics and Gynecology,AIIMS
🇮🇳Delhi, DELHI, India
Dr Priyanka Prabhakar
Principal investigator
7903306116
priyankaprabhakar009@gmail.com