This trial is active, not recruiting.

Conditions polycystic ovarian syndrome, pelvic endometriosis, insulin resistance, non-insulin dependent diabetes mellitus, tubal obstruction
Sponsor Southern Cross Fertility Centre
Start date April 2013
End date September 2013
Trial size 300 participants
Trial identifier NCT01838122, HbA1C-PCOS, PCOS-IR


Women with PCOS have been observed to be potential diabetics.Recently,American Diabetes Association has suggested screening of women with PCOS for HbA1C.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
This group/cohort will have subjects having infertility due to PCOS (as per Rotterdam criteria)
This group/cohort will have subjects without PCOS but with any other diagnosis of infertility or any other complain.

Primary Outcomes

Prevalence of HbA1C in both arms of the cohort of subjects
time frame: September 2013

Eligibility Criteria

Female participants from 15 years up to 40 years old.

Inclusion Criteria: 1. BMI of 25-35 Kg/Mt2 2. Atleast three of the Rotterdam criteria for diagnosis of PCOS. 3. Subjects with well stabilized Thyroid,if they had documented evidence of previousthyroid disorder. Exclusion Criteria: 1. Subjects with documented diagnosis of Metabolic Syndrome. 2. Subjects with laparocopic and histopathologic diagnosis of Endometriosis. 3Subjects with Primary hyperprolectineamia. 4.Subjects with basal FSH >/=15mIU/ml. 5.Subjects with continuously elevated 17-0h-p.

Additional Information

Official title Prevalence of HbA1C in Different Categories of Obesity in Women With PCOS'A Propective Randomized Control Study
Description In view of recent suggestion of American Diabetes Association(ADA)to screen women with PCOS for HbA1C,we intend to study its prevalence in all categories of obesity in women with PCOS. Women with PCOS by Rotterdam criteria will be screened for insulin resistance by using different techniques or tests. Further, the sensitivity and specificity of HbA1C will be compared with sensitivity and specificity of other insulin resistance markers such as OGTT, Free androgen index, free testosterone, fasting insulin to glucose ratio, HOMA-IR and HOMA-B-CELL.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Southern Cross Fertility Centre.