NCT02676518

Brief Summary

Association between serum anti-Mullerian hormone (AMH) level and prevalence of glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS)

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
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

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, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

August 19, 2015

Last Update Submit

February 3, 2016

Conditions

Polycystic Ovary Syndrome

Keywords

polycystic ovary syndromeSerum anti-Mullerian hormoneglucose intolerancemetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • Differences between serum AMH level between PCOS women with and without glucose intolerance and metabolic syndrome

    Any differences between mean of serum AMH levels in PCOS with and without glucose intolerance and metabolic syndrome

    6 months

Secondary Outcomes (2)

  • Percentage of glucose intolerance in PCOS women

    6 months

  • Percentage of metabolic syndrome in PCOS women

    6 months

Study Arms (1)

polycystic ovary syndrome women

PCOS women diagnosed by Rotterdam criteria visiting the Gynecologic Unit at King Chulalongkorn Memorial Hospital and meet the inclusion criteria and no exclusion criteria of the study

Other: serum

Interventions

serumOTHER

Serum for serum anti-Mullerian hormone, 2-hour 75 gram oral glucose tolerance test and lipid profiles

polycystic ovary syndrome women

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Thai women with PCOS diagnosed by Rotterdam criteria 2003 who visit at Gynecological Department, King Chulalongkorn Memorial Hospital, Bangkok,Thailand

You may qualify if:

  • PCOS diagnosed by Rotterdam criteria 2003

You may not qualify if:

  • Pregnancy
  • Previous any hormonal uses in the last 3 months
  • Previous hypoglycemic drugs or insulin-sensitising agents use in the last 3 months
  • Previous chemotherapy, ovarian surgery, pelvic irradiation
  • Menopause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Serum anti-mullerian hormone level * Blood test for 2-hours 75 gram glucose tolerance test * Blood tests for total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides

MeSH Terms

Conditions

Polycystic Ovary SyndromeGlucose IntoleranceMetabolic Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • Dhirapong Charoenvidya, MD

    Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University

    STUDY CHAIR

Central Study Contacts

Wasamon Tunsuparp, MD

CONTACT

66850658502wasamontun@gmail.com

Porntip Sirayapiwat, MD, MSc

CONTACT

66818378923p_siraya@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2015

First Posted

February 8, 2016

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

February 8, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Locations

TH(1)