Health Condition 1: null- Infertility patients attending the outpatient infertility clinic at Department of Obstetrics and gynecology, PGIMER, Chandigarh
Conditions
Interventions
Intervention1: Metformin 500mg tds for 6 months: In the second part of the study, half of the NAFLD women from PCOS patients would be randomised to receive metformin
Control Intervention1: Placebo thr
Sponsors
Council of Scientific and Industrial Research New Delhi India
Eligibility
Inclusion criteria
Inclusion criteria: Two hundred polycystic ovarian women along with equal number of age matched controls with no evidence of polycystic ovarian syndrome would be enrolled after informed consent from the Infertility clinic at Department of Obstetrics and Gynecology, PGIMER, Chandigarh. Inclusion criteria would include (1) 18-40 years of age, (2) not on any therapy that could influence the metabolic or hepatic biochemical parameters in the last 3 months and (3) willing to participate in the study. While the cases would be women with polycystic ovarian syndrome by Rotterdam or NIH criteria, controls would be all other women fulfilling the inclusion criteria but not having polycystic ovarian syndrome.
Exclusion criteria
Exclusion criteria: Exclusion criteria would include (1) women with other causes of irregular menstruation or androgen excess including hyperprolactinemia, uncontrolled thyroid disease, congenital adrenal hyperplasia, premature ovarian failure, cushingâ??s syndrome, androgen secreting tumours (2) history of known liver disease or other medical problems thought to cause elevated liver enzymes (3) history of intake of medication use known to cause an elevation of liver enzymes or (4) history of significant alcohol intake defined as greater than one alcoholic beverage per day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of NAFLD in Polycystic ovarian women versus women with no polycystic ovarian syndrome in Infertility clinics patients at PGIMER, ChandigarhTimepoint: At enrollment in the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the effect of metformin on metabolic, endocrine and hepatic parametersTimepoint: After 3 and 6 months of metformin therapy | — |
Countries
India
Contacts
Public ContactSujata Siwatch
PGIMER, Chandigarh
Outcome results
None listed