EndometriosisNCT04916171
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
An observational study of Endometriosis and Polycystic Ovary Syndrome, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Polycystic Ovary Syndrome, Adenomyosis
- What is being tested?
- incidence
- How many people
- 2,450 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 20 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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. 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.
Who may be able to join
- 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
Who cannot join
- Previously diagnosed with endometriosis, medically or surgically patients receiving treatment
- Patients who have undergone ovarian surgery
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Endometriosis, Polycystic Ovary Syndrome, Adenomyosis
- Being tested
- incidence
- Medical subject headings
- Endometriosis, Polycystic Ovary Syndrome, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incidenceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: incidence | |
| Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis | For the diagnosis of polycystic ovary syndrome, Rotterdam Criteria will be used. Receives: Other: incidence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion20 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916171
- Sponsor's protocol ID
- endopcos
- Status last verified
- Aug 2022
- First submitted
- 1 Jun 2021
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04916171
- Acronym / sponsor ID
- endopcos
- Conditions
- Endometriosis, Polycystic Ovary Syndrome, Adenomyosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,450 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 20 Jan 2023 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome | – | Other: incidenceThe 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. |
| Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis | – | Other: incidenceFor the diagnosis of polycystic ovary syndrome, Rotterdam Criteria will be used. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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. 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Previously diagnosed with endometriosis, medically or surgically patients receiving treatment
- Patients who have undergone ovarian surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| incidenceIt 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. | Other | Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome, Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis |
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.
Time frame: 1 year
The Co-occurrence rate of endometriosis, adenomyosis and polycystic ovarian syndrome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Polycystic Ovary Syndrome, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.