NCT04364087

Brief Summary

Polycystic ovary syndrome (PCOS) is a common endocrine and reproductive disorder in which insulin resistance (IR) is proposed as a key pathophysiological feature of the disease's symptoms and consequences. Diabetes and rediabetes, a significant consequence of IR, are related to a higher risk of diabetes mellitus, future cardiovascular events, and adverse pregnancy outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

April 24, 2020

Last Update Submit

August 21, 2025

Conditions

PCOSInfertilityDiabetesPreDiabetes

Outcome Measures

Primary Outcomes (1)

  • Live birth rate at 24 months following enrollment into the study

    Live birth was defined as the delivery of a live infant after 22 weeks of gestation, regardless of the method of conception.

    From enrollment until delivery (up to 24 months after enrollment)

Secondary Outcomes (9)

  • Gestational diabetes mellitus

    From enrollment until delivery (up to 24 months after enrollment).

  • Hypertensive disorders of pregnancy

    From enrollment until delivery (up to 24 months after enrollment).

  • Miscarriage

    From enrollment until delivery (up to 24 months after enrollment).

  • Preterm birth

    From enrollment until delivery (up to 24 months after enrollment).

  • Birthweight

    At delivery (up to 24 months after enrollment).

  • +4 more secondary outcomes

Study Arms (1)

Infertile PCOS women

All Vietnamese, infertile women, diagnosed with PCOS according to the Rotterdam criteria (2003) at IVFMD Tan Binh and IVFMD Phu Nhuan will be enrolled to the study.

Diagnostic Test: Oral glucose tolerance test

Interventions

Oral glucose tolerance testDIAGNOSTIC_TEST

Oral glucose tolerance test with 75 g glucose (75 g OGTT) will be performed to those with normal fasting glucose and HbA1C levels. Women will be recommended to have normal diet for 3 days and overnight fasting for at least 8 hours. The blood withdrawal will be performed twice: (i) fasting and (2i) 2 hours after solution administration. The volume of blood for each test is 2 ml. Impaired glucose tolerance will be diagnosed when two-hour glucose levels of 140 to 199 mg/dL (7.8 to 11.0 mmol/l) (American Diabetes Association, 2018).

Infertile PCOS women

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infertile Vietnamese women aged 18-40 years, diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam 2003 criteria, who present for infertility treatment at IVFMD.

You may qualify if:

  • Vietnamese women aged 18-40 years
  • Diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria (2003)
  • Having indications for infertility treatment

You may not qualify if:

  • Thyroid-stimulating hormone (TSH) \> 5 mIU/mL
  • Serum prolactin (PRL) \> 30 ng/mL
  • History of hypothyroidism
  • Cushing's syndrome
  • Premature ovarian insufficiency
  • Late-onset or non-classic congenital adrenal hyperplasia
  • Any other concomitant endocrinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

InfertilityDiabetes MellitusPrediabetic State

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Lan TN Vuong, MS, PhD

    Mỹ Đức Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 27, 2020

Study Start

June 1, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)