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

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Brief Title

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

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

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 Type

Observational


Primary Outcome

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.


Condition

Endometriosis

Intervention

incidence

Study Arms / Comparison Groups

 Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

2450

Start Date

June 1, 2021

Completion Date

June 20, 2022

Primary Completion Date

June 1, 2022

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
      

Gender

Female

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT04916171

Organization ID

endopcos


Responsible Party

Principal Investigator

Study Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Collaborators

 Engin Oral

Study Sponsor

, , 


Verification Date

August 2021