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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04916171
• Other study ID #: endopcos
• Status: Active, not recruiting
• Start date: June 1, 2021
• Est. completion date: January 20, 2023

Study information

• Verified date: August 2022
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2450
• Est. completion date: January 20, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Endometriosis
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• incidence
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.

Locations

Country	Name	City	State
Turkey	Pinar Yalcin Bahat	Istanbul	I?stanbul

Sponsors (13)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital	Ahmet Basar Tekin, Ali Kolusari, Banu Yilmaz, Berna Dilbaz, Cem Atabekoglu, Cihan Kaya, Engin Oral, Engin Yildirim, Gokce Anik Ilhan, Gürkan Bozdag, Nuray Bozkurt, Servet Ozden hacivelioglu

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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