Intrauterine Device MigrationNCT05956184
Intrauterine Device Insertion and Felt Pain
A study testing Intrauterine Device Insertion in people with Intrauterine Device Migration, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the pain score between the direct method and the conventional method in patients who have undergone copper or hormonal intrauterine devices (IUD) for contraception and to find an answer to the question of which method is better. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Device Migration
- What is being tested?
- Intrauterine Device Insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jul 2023to 1 Sep 2023
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer to participate in the study
- Preferring an intrauterine device for the contraceptive method
Who cannot join
- Patients with uterine leiomyoma
- Patients with endometriosis
- Patients with chronic pelvic pain
- Patients with familial mediterranean fever
- Patients who experienced complications during the procedure
- Patients who developed vasovagal reactions
- Patients who had previously used an IUD for any reason
- Patients with uterine anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrauterine Device Insertion and Felt Pain: Which Method is Better?
The aim of this study is to compare the pain score between the direct method and the conventional method in patients who have undergone copper or hormonal intrauterine devices (IUD) for contraception and to find an answer to the question of which method is better.
Read the detailed description
The intrauterine device (IUD) is one of the commonly used methods of contraception due to its effectiveness in providing reliable contraception, its ease of application, non-obstruction of sexual life, affordability, minimal absolute contraindications, and reversibility. Despite this increasing preference, concerns regarding the use of both levonorgestrel-releasing and copper IUDs due to the potential pain and fear of pain during insertion, which has hindered the adoption of this method.
Although the conventional method is used for intrauterine device insertion, the authors defined the direct method, also known as the torpedo technique, in 2006. IUD practitioners have started to prefer this direct method because it is simpler, faster and has fewer insertion steps than the conventional technique. However, IUD practitioners should apply the most painless and tolerable method to women who choose an IUD for contraception. Therefore, in order to understand which method is less painful, patients will be divided into 2 groups as those who have IUD inserted with the conventional method and those who have IUD inserted with the direct method. At the end of the procedure, participants in both groups will be asked to rate the most severe pain they experienced during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10).
In the conventional method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD was inserted.
In the direct method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and without using hysterometry the IUD was directly inserted.
- Conditions
- Intrauterine Device Migration
- Being tested
- Intrauterine Device Insertion
- Keywords
- Pain, Intrauterine Devices, Conventional Technique, Direct Technique, IUD
- Medical subject headings
- Intrauterine Device Migration, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine Device InsertionDevice
All womens will be placed in a gynecological position and underwent a bimanual examination to better determine whether the uterus was in the anteverted or retroverted position. Subsequently, a speculum will be inserted, and the cervix will be disinfected with betadine. In the conventional method: the anterior lip of the cervix is grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD is inserted. In the direct method: the anterior lip of the cervix is grasped and pulled with Pozzi forceps, and without using hysterometry the IUD is directly inserted. The strings will be cut approximately 2-3 cm after the cervix, and the Pozzi forceps and speculum will be removed. The accuracy of the IUD placement will be confirmed using pelvic ultrasound. The process will take about five minutes.
| Study group | Role | What they receive |
|---|---|---|
| Convention Method Group | Active comparator | Women who have an IUD inserted by conventional method will be asked to rate the most severe pain they experience during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10). Receives: Device: Intrauterine Device Insertion |
| Direct Method Group | Active comparator | Women who have an IUD inserted by direct method will be asked to rate the most severe pain they experience during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10). Receives: Device: Intrauterine Device Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
This is a numeric pain score evaluated as "painless" (score=0) and "worst pain" (score=10). Score <3 mild pain, 3-6 mild-moderate pain, and >6 moderate-to-severe pain.
Measured: Thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start13 Jul 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrauterine Device MigrationStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups as conventional method and direct method
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad İbrahim Halilzade, Ankara City Hospital Bilkent
- Investigators
- Mohammad I Halilzade, M.D., Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956184
- Sponsor's protocol ID
- ACH-KHD-MIH-01
- Status last verified
- Sep 2023
- First submitted
- 13 Jul 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halilzade MI, Halilzade I, Turgay B, Kilickiran H, Turkmen O, Ozaksit MG. Effect of uterine sound on pain perception during intrauterine device insertion: A randomized trial. Medicine (Baltimore). 2025 Aug 1;104(31):e43721. doi: 10.1097/MD.0000000000043721.
PubMed 40760565
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Device Insertion and Felt Pain: Which Method is Better?
- ClinicalTrials.gov ID
- NCT05956184
- Acronym / sponsor ID
- ACH-KHD-MIH-01
- Conditions
- Intrauterine Device Migration
- Keywords
- Pain, Intrauterine Devices, Conventional Technique, Direct Technique, IUD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 21 Jul 2023 (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 aim of this study is to compare the pain score between the direct method and the conventional method in patients who have undergone copper or hormonal intrauterine devices (IUD) for contraception and to find an answer to the question of which method is better.
Detailed description
The intrauterine device (IUD) is one of the commonly used methods of contraception due to its effectiveness in providing reliable contraception, its ease of application, non-obstruction of sexual life, affordability, minimal absolute contraindications, and reversibility. Despite this increasing preference, concerns regarding the use of both levonorgestrel-releasing and copper IUDs due to the potential pain and fear of pain during insertion, which has hindered the adoption of this method.
Although the conventional method is used for intrauterine device insertion, the authors defined the direct method, also known as the torpedo technique, in 2006. IUD practitioners have started to prefer this direct method because it is simpler, faster and has fewer insertion steps than the conventional technique. However, IUD practitioners should apply the most painless and tolerable method to women who choose an IUD for contraception. Therefore, in order to understand which method is less painful, patients will be divided into 2 groups as those who have IUD inserted with the conventional method and those who have IUD inserted with the direct method. At the end of the procedure, participants in both groups will be asked to rate the most severe pain they experienced during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10).
In the conventional method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD was inserted.
In the direct method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and without using hysterometry the IUD was directly inserted.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups as conventional method and direct method
| Arm | Type | Receives |
|---|---|---|
| Convention Method Group | Active comparator | Device: Intrauterine Device InsertionWomen who have an IUD inserted by conventional method will be asked to rate the most severe pain they experience during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10). |
| Direct Method Group | Active comparator | Device: Intrauterine Device InsertionWomen who have an IUD inserted by direct method will be asked to rate the most severe pain they experience during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Volunteer to participate in the study
- Preferring an intrauterine device for the contraceptive method
Key exclusion criteria (8 listed)
- Patients with uterine leiomyoma
- Patients with endometriosis
- Patients with chronic pelvic pain
- Patients with familial mediterranean fever
- Patients who experienced complications during the procedure
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 |
|---|---|---|
| Intrauterine Device InsertionAll womens will be placed in a gynecological position and underwent a bimanual examination to better determine whether the uterus was in the anteverted or retroverted position. Subsequently, a speculum will be inserted, and the cervix will be disinfected with betadine. In the conventional method: the anterior lip of the cervix is grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD is inserted. In the direct method: the anterior lip of the cervix is grasped and pulled with Pozzi forceps, and without using hysterometry the IUD is directly inserted. The strings will be cut approximately 2-3 cm after the cervix, and the Pozzi forceps and speculum will be removed. The accuracy of the IUD placement will be confirmed using pelvic ultrasound. The process will take about five minutes. | Device | Convention Method Group, Direct Method Group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Thirty minutes
This is a numeric pain score evaluated as "painless" (score=0) and "worst pain" (score=10). Score <3 mild pain, 3-6 mild-moderate pain, and >6 moderate-to-severe pain.
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 5 Sep 2023.
- Derived from this study: PubMed 40760565Halilzade MI, Halilzade I, Turgay B, Kilickiran H, Turkmen O, Ozaksit MG. Effect of uterine sound on pain perception during intrauterine device insertion: A randomized trial. Medicine (Baltimore). 2025 Aug 1;104(31):e43721. doi: 10.1097/MD.0000000000043721.
- Individual participant dataSharing planned: No
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.
Mohammad I Halilzade, M.D. principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine Device Insertion in people with Intrauterine Device Migration, run by Ankara City Hospital Bilkent 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 2 inclusion and 8 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 5 Sep 2023. 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?
Visual Analogue Scale (VAS) (time frame: Thirty minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05956184, which also lists 1 linked publication.
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 5 Sep 2023.