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Clinical Trials/NCT04916171
NCT04916171
Unknown
Not Applicable

The Incidence of Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome, or the Incidence of Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis

Kanuni Sultan Suleyman Training and Research Hospital1 site in 1 country2,450 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Enrollment
2450
Locations
1
Primary Endpoint
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.
Last Updated
3 years ago

Overview

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.

Detailed Description

For the diagnosis of polycystic ovary syndrome, Rotterdam Criteria will be used. Hyperandrogenism will be determined clinically by Ferriman-Gallwey scoring, and biochemically by serum total testosterone and sex hormone initiating globulin (SHBG). 21-24 and 28-31 of menstruation in patients with ovulatory dysfunction, oligomenorrhea (cycles lasting longer than 38 days). It will be determined by measuring the serum progesterone level between days Polycystic ovarian morphology will be determined by transvaginal ultrasonography (8 mHz probe) by calculating the number of antral follicles and ovarian volume. Serum Anti Mullerian Hormone (AMH) will be requested from patients being investigated for polycystic ovary syndrome. In order to exclude other conditions during the investigation in patients with suspected polycystic ovary syndrome, serum thyroid stimulating hormone (TSH), prolactin (PRL) and 17-hydroxyprogesterone (17-OHP) levels will be checked in the first 7 days of menstruation. 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. 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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
January 20, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pınar Yalcin bahat

Principal Investigator

Kanuni Sultan Suleyman Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: 1 year

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

Study Sites (1)

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