NCT01838122

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

5 months

First QC Date

April 15, 2013

Last Update Submit

April 18, 2013

Conditions

Polycystic Ovarian SyndromePelvic EndometriosisInsulin ResistanceNon-insulin Dependent Diabetes MellitusTubal Obstruction

Keywords

PCOSHbA1CInsulin resistanceOGTTHOMA-IRHOMA-B-cell

Outcome Measures

Primary Outcomes (1)

  • Prevalence of HbA1C in both arms of the cohort of subjects

    HbA1C has been suggested as a potential marker for NIDDM in subjects with PCOS

    September 2013

Study Arms (2)

Study Arm

This group/cohort will have subjects having infertility due to PCOS (as per Rotterdam criteria)

Control arm

This group/cohort will have subjects without PCOS but with any other diagnosis of infertility or any other complain.

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

This population will have subjects with diagnosis of PCOS,by Rotterdam criteria regardless of complain(s)

You may qualify if:

  • BMI of 25-35 Kg/Mt2
  • Atleast three of the Rotterdam criteria for diagnosis of PCOS.
  • Subjects with well stabilized Thyroid,if they had documented evidence of previousthyroid disorder.

You may not qualify if:

  • Subjects with documented diagnosis of Metabolic Syndrome.
  • Subjects with laparocopic and histopathologic diagnosis of Endometriosis. 3Subjects with Primary hyperprolectineamia.
  • Subjects with basal FSH \>/=15mIU/ml. 5.Subjects with continuously elevated 17-0h-p.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Cross Fertility Centre

Mumbai, Maharashtra, 400025, India

Location

Related Publications (1)

  • Kim JJ, Choi YM, Cho YM, Jung HS, Chae SJ, Hwang KR, Hwang SS, Ku SY, Kim SH, Kim JG, Moon SY. Prevalence of elevated glycated hemoglobin in women with polycystic ovary syndrome. Hum Reprod. 2012 May;27(5):1439-44. doi: 10.1093/humrep/des039. Epub 2012 Feb 21.

    PMID: 22357766RESULT

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin ResistanceDiabetes Mellitus, Type 2Fallopian Tube Diseases

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes Mellitus

Study Officials

  • Manchi R Bharucha, Ph.D

    Southern Cross Fertility Centre

    STUDY DIRECTOR

  • Manchi R Bharucha, Ph.D.

    Souther Cross Fertility Centre

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faram E.Irani

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 23, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

November 1, 2013

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

IN(1)