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Prevalence of HbA1C in Women With PCOS (WHI)

S

Southern Cross Fertility Centre

Status

Unknown

Conditions

Non-insulin Dependent Diabetes Mellitus
Pelvic Endometriosis
Insulin Resistance
Polycystic Ovarian Syndrome
Tubal Obstruction

Study type

Observational

Funder types

Other

Identifiers

NCT01838122
PCOS-IR (Registry Identifier)
HbA1C-PCOS

Details and patient eligibility

About

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

Full 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.

Enrollment

300 estimated patients

Sex

Female

Ages

15 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Study Arm
Description:
This group/cohort will have subjects having infertility due to PCOS (as per Rotterdam criteria)
Control arm
Description:
This group/cohort will have subjects without PCOS but with any other diagnosis of infertility or any other complain.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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