Intrauterine DeviceNCT05556421
Can Uterocervical Angle Predict the Displacement of Copper Intrauterine Devices (T-Cu 380A)
An observational study of Intrauterine Device, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators conducted a case-control study between December 2020-June 2021 at Istanbul Health Sciences University Kanuni Sultan Suleyman Training and Research Hospital family planning outpatient clinics. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Device
- What is being tested?
- uterocervical angle
- How many people
- 123 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jul 2021
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The female patients between the ages of 21-45 who applied to either gynecology or family planning outpatient clinics and who had been using copper IUD (T Cu 380-A) as a contraception method for the last 6 weeks to 5 years were included in the study. Patients were included in the study on a voluntary basis.
Who may be able to join
- Patients aged between 21-45
Who cannot join
- Patients under the age of twenty-one and over the age of 45
- Patients applied to the hospital within the first 6 weeks after copper IUD insertion
- Patients with Space-occupying lesions (polyp, fibroid) in the uterine cavity
- Patients who have and/or had a pelvic inflammatory disease
- Patients who had Ascus, Hgsil, Lgsil, CIN (1,2,3), carcinoma in situ, and malignancy in their smear results before the study started or detected during the study period, and patients who were done LEEP or conization procedures due to these pathologies.
- Patients with Descensus uteri
Show all 11Show fewer
- Patients with cervical polyps
- Patients with connective tissue disease I- Patients with uterine myomas or adenomyosis
- Patients with uterine anomaly
- Patients with vaginal infection or recurrent vaginitis and patients with abnormal uterine bleeding
- l- Patients with immune-compromised situations such as AIDS, drug use, or cortisone treatment m- Patients using anticoagulants for any reason n- Patients who have known Copper allergy or rare Copper metabolism disease (Wilson disease)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Istanbul, 34307
About this study
The investigators conducted a case-control study between December 2020-June 2021 at Istanbul Health Sciences University Kanuni Sultan Suleyman Training and Research Hospital family planning outpatient clinics. One hundred and forty-three patients who had copper intrauterine devices (T Cu 380 A) inserted for contraception were evaluated between the 6th week to 5 years after insertion. Patients were divided into two groups according to their ultrasonographic examinations as "displaced" or "normal" positions. Uterocervical angles were measured of both groups by transvaginal ultrasonography and investigated whether the uterocervical angle had any effect in predicting the displacement of copper intrauterine devices.
Read the detailed description
Family planning contains various protection methods, and copper intrauterine devices (IUD) are one of these. It has come forward among the contraception methods due to its long-acting effect, rapid return of fertility when discontinued, and ease of use. In worldwide usage, IUDs are the third most common method of contraception after tubal ligation and male condoms (1). When long-acting contraception methods were compared, the failure rate of the IUD was 0.8% per 100 women within one year (2). Factors affecting failure were; the application time of IUDs (3), application technique (4), uterus dimensions (5), endometrial cavity length (6), parity (7), and mode of delivery (8).
Uterocervical angle (UCA) is the angle measured in the triangle region between the anterior uterine segment and the cervical canal (9). UCA has been evaluated to predict the threat of preterm birth in national and international studies (9,10). In the literature, UCA has not been used in any studies within the scope of family planning. Our study aimed to investigate the feasibility of uterocervical angle measurements in predicting the dislocation of IUDs.
- Conditions
- Intrauterine Device
- Being tested
- uterocervical angle
- Keywords
- displacement, contraception, family planning, T-Cu 380A, uterocervical angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterocervical angleDiagnostic test
uterocervical angles were measured for both groups by transvaginal ultrasonography and investigated whether the uterocervical angle had any effect in predicting the displacement of copper intrauterine devices.
| Study group | Role | What they receive |
|---|---|---|
| case group | dislocated intrauterine device Receives: Diagnostic Test: uterocervical angle | |
| control group | normal intrauterine device position Receives: Diagnostic Test: uterocervical angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
uterocervical angle
Uterocervical angle (UCA) is the angle measured in the triangle region between the anterior uterine segment and the cervical canal
Measured: 6 months
Secondary outcomes (2)
uterine volume
Uterine volume was accepted as ellipsoid with transvaginal ultrasonography device measured in transverse, longitudinal, and antero-posterior planes and volume was calculated in cm3.
Measured: 6 months
endometrial cavity length
The length of the endometrial cavity (ECL) was determined as the canal extending from the beginning of the internal cervical os to the uterine fundus endometrium.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Jan 2021
- Primary completion1 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine DeviceStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozan Karadeniz, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556421
- Sponsor's protocol ID
- KanuniSSEAH2
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Uterocervical Angle Predict the Displacement of Copper Intrauterine Devices (T-Cu 380A)
- ClinicalTrials.gov ID
- NCT05556421
- Acronym / sponsor ID
- KanuniSSEAH2
- Conditions
- Intrauterine Device
- Keywords
- displacement, contraception, family planning, T-Cu 380A, uterocervical angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 27 Sep 2022 (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 investigators conducted a case-control study between December 2020-June 2021 at Istanbul Health Sciences University Kanuni Sultan Suleyman Training and Research Hospital family planning outpatient clinics. One hundred and forty-three patients who had copper intrauterine devices (T Cu 380 A) inserted for contraception were evaluated between the 6th week to 5 years after insertion. Patients were divided into two groups according to their ultrasonographic examinations as "displaced" or "normal" positions. Uterocervical angles were measured of both groups by transvaginal ultrasonography and investigated whether the uterocervical angle had any effect in predicting the displacement of copper intrauterine devices.
Detailed description
Family planning contains various protection methods, and copper intrauterine devices (IUD) are one of these. It has come forward among the contraception methods due to its long-acting effect, rapid return of fertility when discontinued, and ease of use. In worldwide usage, IUDs are the third most common method of contraception after tubal ligation and male condoms (1). When long-acting contraception methods were compared, the failure rate of the IUD was 0.8% per 100 women within one year (2). Factors affecting failure were; the application time of IUDs (3), application technique (4), uterus dimensions (5), endometrial cavity length (6), parity (7), and mode of delivery (8).
Uterocervical angle (UCA) is the angle measured in the triangle region between the anterior uterine segment and the cervical canal (9). UCA has been evaluated to predict the threat of preterm birth in national and international studies (9,10). In the literature, UCA has not been used in any studies within the scope of family planning. Our study aimed to investigate the feasibility of uterocervical angle measurements in predicting the dislocation of IUDs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: uterocervical angledislocated intrauterine device |
| control group | – | Diagnostic Test: uterocervical anglenormal intrauterine device position |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The female patients between the ages of 21-45 who applied to either gynecology or family planning outpatient clinics and who had been using copper IUD (T Cu 380-A) as a contraception method for the last 6 weeks to 5 years were included in the study. Patients were included in the study on a voluntary basis.
Key inclusion criteria (1 listed)
- Patients aged between 21-45
Key exclusion criteria (11 listed)
- Patients under the age of twenty-one and over the age of 45
- Patients applied to the hospital within the first 6 weeks after copper IUD insertion
- Patients with Space-occupying lesions (polyp, fibroid) in the uterine cavity
- Patients who have and/or had a pelvic inflammatory disease
- Patients who had Ascus, Hgsil, Lgsil, CIN (1,2,3), carcinoma in situ, and malignancy in their smear results before the study started or detected during the study period, and patients who were done LEEP or conization procedures due to these pathologies.
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 |
|---|---|---|
| uterocervical angleuterocervical angles were measured for both groups by transvaginal ultrasonography and investigated whether the uterocervical angle had any effect in predicting the displacement of copper intrauterine devices. | Diagnostic test | case group, control group |
Primary outcome
uterocervical angle
Time frame: 6 months
Uterocervical angle (UCA) is the angle measured in the triangle region between the anterior uterine segment and the cervical canal
2 secondary outcomes
uterine volume
Time frame: 6 months
endometrial cavity length
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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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 Intrauterine Device, 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 12 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
uterocervical angle (time frame: 6 months). 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 12 Sep 2025.