NCT04916171

Brief Summary

The study was designed as a multicenter, prospective cross-sectional cohort study. The research population will consist of patients under the age of 40, diagnosed with endometriosis and/or adenomyosis and polycystic ovary syndrome, who applied to the obstetrics and gynecology outpatient clinics in 13 centers. According to the results of the sample size analysis, it was planned to terminate the study when 1225 patients with polycystic ovary syndrome and 1225 patients with endometriosis and/or adenomyosis were recruited.

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
2,450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

June 1, 2021

Last Update Submit

August 10, 2022

Conditions

EndometriosisPolycystic Ovary SyndromeAdenomyosis

Outcome Measures

Primary Outcomes (1)

  • Demonstration of the co-occurrence of endometriosis, adenomyosis and polycystic ovarian syndrome in women of reproductive age under 40 years of age in our country.

    The Co-occurrence rate of endometriosis, adenomyosis and polycystic ovarian syndrome

    1 year

Study Arms (2)

Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome

The diagnosis of endometriosis will be made by the presence of ovarian endometrioma and/or a deep infiltrating endometriosis nodule determined by transvaginal ultrasonography or by palpation of the endometriotic nodule on pelvic examination or surgical confirmation. The diagnosis of adenomyosis will be made by transvaginal ultrasonography or surgical confirmation.

Other: incidence

Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis

For the diagnosis of polycystic ovary syndrome, Rotterdam Criteria will be used.

Other: incidence

Interventions

incidenceOTHER

It is aimed to determine the incidence of endometriosis and/or adenomyosis in patients diagnosed with polycystic ovary syndrome, or to determine the incidence of polycystic ovary syndrome in patients diagnosed with endometriosis and/or adenomyosis.

Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary SyndromePolycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis

Eligibility Criteria

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

The research population will consist of patients under the age of 40, diagnosed with endometriosis and/or adenomyosis and polycystic ovary syndrome, who applied to the obstetrics and gynecology outpatient clinics in 13 centers. According to the results of the sample size analysis, it was planned to terminate the study when 1225 patients with polycystic ovary syndrome and 1225 patients with endometriosis and/or adenomyosis were recruited. For polycystic ovary syndrome in patients diagnosed with endometriosis and/or adenomyosis; For endometriosis and/or adenomyosis in patients diagnosed with polycystic ovary syndrome, the above-described diagnostic investigations will be performed.

You may qualify if:

  • Having been diagnosed with endometriosis by ultrasound or surgery(after diagnosed)
  • Being a newly diagnosed endometriosis patient
  • Not using any hormones or additional drugs
  • Not having undergone ovarian surgery
  • Patients diagnosed with PCOS according to the Rotterdam diagnostic criteria

You may not qualify if:

  • Previously diagnosed with endometriosis, medically or surgically patients receiving treatment
  • Patients who have undergone ovarian surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

EndometriosisPolycystic Ovary SyndromeAdenomyosis

Interventions

Incidence

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGonadal DisordersEndocrine System DiseasesUterine Diseases

Intervention Hierarchy (Ancestors)

MorbidityVital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 7, 2021

Study Start

June 1, 2021

Primary Completion

December 31, 2022

Study Completion

January 20, 2023

Last Updated

August 11, 2022

Record last verified: 2022-08

Locations

TU(1)