Determination of 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

• Conditions: Endometriosis; Adenomyosis; Polycystic Ovary Syndrome
• Interventions: Other: incidence

• Registration Number: NCT04916171
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-11
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2450

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome	incidence	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.
Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis	incidence	For the diagnosis of polycystic ovary syndrome, Rotterdam Criteria will be used.

Primary Outcome Measures

Name	Time	Method
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.	1 year	The Co-occurrence rate of endometriosis, adenomyosis and polycystic ovarian syndrome

Trial Locations

Locations (1)

Pinar Yalcin Bahat; 🇹🇷 Istanbul, İ̇stanbul, Turkey