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

NCT ID: NCT04916171

Last Updated: 2022-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-01-20

Brief Summary

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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

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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.

Conditions

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Endometriosis Polycystic Ovary Syndrome Adenomyosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

incidence

Intervention Type OTHER

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.

incidence

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Engin Oral

UNKNOWN

Sponsor Role collaborator

Berna Dilbaz

UNKNOWN

Sponsor Role collaborator

Gürkan Bozdag

UNKNOWN

Sponsor Role collaborator

Cem Atabekoğlu

UNKNOWN

Sponsor Role collaborator

Nuray Bozkurt

UNKNOWN

Sponsor Role collaborator

Gokce Anik Ilhan

UNKNOWN

Sponsor Role collaborator

Ali Kolusari

UNKNOWN

Sponsor Role collaborator

Cihan Kaya

UNKNOWN

Sponsor Role collaborator

Banu Yılmaz

UNKNOWN

Sponsor Role collaborator

Engin Yildirim

UNKNOWN

Sponsor Role collaborator

Ahmet Başar Tekin

UNKNOWN

Sponsor Role collaborator

Servet Ozden hacivelioglu

UNKNOWN

Sponsor Role collaborator

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pınar Yalcin bahat

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pinar Yalcin Bahat

Istanbul, İ̇stanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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endopcos

Identifier Type: -

Identifier Source: org_study_id

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