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

Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04916171
Collaborator
Engin Oral (Other), Berna Dilbaz (Other), Gürkan Bozdag (Other), Cem Atabekoğlu (Other), Nuray Bozkurt (Other), Gokce Anik Ilhan (Other), Ali Kolusari (Other), Cihan Kaya (Other), Banu Yılmaz (Other), Engin Yildirim (Other), Ahmet Başar Tekin (Other), Servet Ozden hacivelioglu (Other)
2,450
1
19.6
124.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: incidence

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 Design

Study Type:
Observational
Anticipated Enrollment :
2450 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jan 20, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  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. [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pinar Yalcin Bahat Istanbul İ̇stanbul Turkey 34000

Sponsors and Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital
  • Engin Oral
  • Berna Dilbaz
  • Gürkan Bozdag
  • Cem Atabekoğlu
  • Nuray Bozkurt
  • Gokce Anik Ilhan
  • Ali Kolusari
  • Cihan Kaya
  • Banu Yılmaz
  • Engin Yildirim
  • Ahmet Başar Tekin
  • Servet Ozden hacivelioglu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pınar Yalcin bahat, Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04916171
Other Study ID Numbers:
  • endopcos
First Posted:
Jun 7, 2021
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022