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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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04916171
Enrollment
2450
Registered
2021-06-07
Start date
2021-06-01
Completion date
2023-01-20
Last updated
2022-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis, Endometriosis, Polycystic Ovary Syndrome

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.

Interventions

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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
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 yearThe Co-occurrence rate of endometriosis, adenomyosis and polycystic ovarian syndrome

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026