IUCD ComplicationNCT06806358
Clinical and Ultrasonographic Predictors of IUD Related Complications
A study testing IUD insertion in people with IUCD Complication, run by Cairo University at 1 site in Egypt.
Trial summary
All patients fulfilling the selection criteria undergo complete clinical examination and detailed medical history obtained. Each patient had a Case Record Form (CRF) recording participants' name. Read more about this study
- Who is it for?
- Ages 20 to 41 years, women only
- Conditions the study is for
- IUCD Complication
- What is being tested?
- IUD insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 7 Jun 2026
- 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 20 to 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 -41 years
- BMI 18-25 kg/m2
- Women with any parity seeking contraception and choosing IUD as their preferred method after proper and thorough counseling
- Regularly menstruating women (duration of menstruation 3-7 days and length of cycle 22- 35 days).
- Not using any hormonal therapy or anticoagulation
Who cannot join
- Cervical abnormalities.
- Pregnancy or suspicion of pregnancy
- Congenital or acquired uterine anomalies which distort the uterine cavity (fibroids, endometrial polyps, cervical stenosis, bicornuate uterus, hypoplastic uterus < 6 cm)
- Acute PID or a history of PID within the past 3 months
- Postpartum or post-abortion endometritis within the past 3 months
- Current STI or within the past 3 months (including cervicitis)
Show all 13Show fewer
- Cervical cancer
- Endometrial cancer
- Malignant gestational trophoblastic disease
- Undiagnosed vaginal bleeding
- Hypersensitivity to any component in the IUD (copper)
- Less than 6 weeks postpartum.
- Neurological or psychological conditions that may affect pain sensation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Ultrasonographic Predictors of IUD Related Complications: A Prospective Cohort Study
- All patients fulfilling the selection criteria undergo complete clinical examination and detailed medical history obtained. Each patient had a Case Record Form (CRF) recording participants' name. number, previous deliveries and abortions, age, height, weight, BMI, LMP, past medical and surgical history and contraceptive history.
- All participants will be subjected to transvaginal ultrasound to measure uterine size, endometrial and myometrial thickness, uterine position, cervical length, cervical diameter and for detection of any contraindications for IUD insertion.
Power Doppler Energy (PDE) measurement for subendometrial microvascularization will be done and categorized as women with minor subendometrial vascularization (Classifications I and II) and major subendometrial vascularization (Classifications III, IV and V)
Read the detailed description
All patients fulfilling the selection criteria undergo complete clinical examination and detailed medical history obtained. Each patient had a Case Record Form (CRF) recording participants' name. number, previous deliveries and abortions, age, height, weight, BMI, LMP, past medical and surgical history and contraceptive history.
- All participants will be subjected to transvaginal ultrasound to measure uterine size, endometrial and myometrial thickness, uterine position, cervical length, cervical diameter and for detection of any contraindications for IUD insertion.
Power Doppler Energy (PDE) measurement for subendometrial microvascularization will be done and categorized as women with minor subendometrial vascularization (Classifications I and II) and major subendometrial vascularization (Classifications III, IV and V)
Only clinicians with proven proficiency in IUD insertion will be allowed to perform insertions.
- Perform a bimanual examination to determine the size, shape, and position of the uterus.
- Insert a warm, moistened speculum.
- Cleanse the cervix with an antiseptic solution.
- Open the sterile insertion instruments without touching the inside of the packet and place within easy reach.
- Remove the tenaculum by its handle and grasp the anterior or posterior lip of the cervix. Close gently to the first notch. Having the woman to cough while the tenaculum is being attached can ease the pinch.
- Apply gentle traction with the tenaculum to straighten the canal.
- Remove the sound by its handle and gently insert it to measure the depth of the uterus. Do not apply great force if there is resistance. Apply further traction to the tenaculum and attempt to re-insert the sound at a different angle. Once the sound is inserted and removed, note the depth of the uterine cavity. The woman can expect to feel cramping as the sound is inserted and withdrawn.
- Open the IUD pack without touching its contents.
- Put on sterile gloves.
- Load the IUD and insert it into the uterine cavity according to the manufacturer instructions. As the IUD is inserted through the cervix into the uterus, the patient may have pain and cramping similar to strong menstrual cramps.
- Gently remove the tenaculum. Tamponade any bleeding from the tenaculum site until it is resolved.
- Trim the strings of the IUD to 3-4 cm in length and note the string length. Avoid cutting the strings too short. If the client or her partner becomes aware of the threads, they may be cut shorter in length at the follow-up visit.
- Remove the speculum and assess the woman.
- Pain score will be assessed using Visual Analogue Scale:
- Anticipated pain or current pain before the intervention.
- Immediately after speculum insertion.
- Immediately after tenaculum placement.
- Immediately after uterine sounding.
- During or immediately after IUD insertion.
- Five minutes after the procedure
- Follow up at 3 and 6 months to assess women satisfaction with the method, menstrual pattern, symptoms of vaginal/pelvic infection Abdominal pain/tenderness Dyspareunia (woman/partner) Cramping or pregnancy.
- Vaginal examination to assess any infections or abnormalities and repeat ultrasound examination to assess the position of the IUD
- Conditions
- IUCD Complication
- Being tested
- IUD insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUD insertionDevice
- Perform a bimanual examination
- Insert a warm, moistened speculum.
- Cleanse the cervix with an antiseptic solution.
- Open the sterile insertion instruments without touching
- Remove the tenaculum by its handle and grasp the anterior or posterior lip of the cervix.
- Apply gentle traction with the tenaculum to straighten the canal.
- Remove the sound by its handle and gently insert it to measure the depth of the uterus. Do not apply great force if there is resistance. Apply further traction to the tenaculum and attempt to re-insert the sound at a different angle. Once the sound is inserted and removed
- Open the IUD pack without touching its contents.
- Put on sterile gloves.
- Load the IUD and insert it into the uterine cavity according to the manufacturer instructions.
- Gently remove the tenaculum.
- Trim the strings of the IUD to 3-4 cm in length
- Remove the speculum and assess the woman.
| Study group | Role | What they receive |
|---|---|---|
| IUD insertion | Experimental | IUD insertion in women needing contraception Receives: Device: IUD insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failed IUD insertion
failure of IUD insertion
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Feb 2025
- Primary completion12 May 2026
- Study completion7 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUCD ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- IUCD insertion
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806358
- Sponsor's protocol ID
- N 362
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Ultrasonographic Predictors of IUD Related Complications: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06806358
- Acronym / sponsor ID
- N 362
- Conditions
- IUCD Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 7 Jun 2026 (actual)
- First posted
- 4 Feb 2025 (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.
- All patients fulfilling the selection criteria undergo complete clinical examination and detailed medical history obtained. Each patient had a Case Record Form (CRF) recording participants' name. number, previous deliveries and abortions, age, height, weight, BMI, LMP, past medical and surgical history and contraceptive history.
- All participants will be subjected to transvaginal ultrasound to measure uterine size, endometrial and myometrial thickness, uterine position, cervical length, cervical diameter and for detection of any contraindications for IUD insertion.
Power Doppler Energy (PDE) measurement for subendometrial microvascularization will be done and categorized as women with minor subendometrial vascularization (Classifications I and II) and major subendometrial vascularization (Classifications III, IV and V)
Detailed description
All patients fulfilling the selection criteria undergo complete clinical examination and detailed medical history obtained. Each patient had a Case Record Form (CRF) recording participants' name. number, previous deliveries and abortions, age, height, weight, BMI, LMP, past medical and surgical history and contraceptive history.
- All participants will be subjected to transvaginal ultrasound to measure uterine size, endometrial and myometrial thickness, uterine position, cervical length, cervical diameter and for detection of any contraindications for IUD insertion.
Power Doppler Energy (PDE) measurement for subendometrial microvascularization will be done and categorized as women with minor subendometrial vascularization (Classifications I and II) and major subendometrial vascularization (Classifications III, IV and V)
Only clinicians with proven proficiency in IUD insertion will be allowed to perform insertions.
- Perform a bimanual examination to determine the size, shape, and position of the uterus.
- Insert a warm, moistened speculum.
- Cleanse the cervix with an antiseptic solution.
- Open the sterile insertion instruments without touching the inside of the packet and place within easy reach.
- Remove the tenaculum by its handle and grasp the anterior or posterior lip of the cervix. Close gently to the first notch. Having the woman to cough while the tenaculum is being attached can ease the pinch.
- Apply gentle traction with the tenaculum to straighten the canal.
- Remove the sound by its handle and gently insert it to measure the depth of the uterus. Do not apply great force if there is resistance. Apply further traction to the tenaculum and attempt to re-insert the sound at a different angle. Once the sound is inserted and removed, note the depth of the uterine cavity. The woman can expect to feel cramping as the sound is inserted and withdrawn.
- Open the IUD pack without touching its contents.
- Put on sterile gloves.
- Load the IUD and insert it into the uterine cavity according to the manufacturer instructions. As the IUD is inserted through the cervix into the uterus, the patient may have pain and cramping similar to strong menstrual cramps.
- Gently remove the tenaculum. Tamponade any bleeding from the tenaculum site until it is resolved.
- Trim the strings of the IUD to 3-4 cm in length and note the string length. Avoid cutting the strings too short. If the client or her partner becomes aware of the threads, they may be cut shorter in length at the follow-up visit.
- Remove the speculum and assess the woman.
- Pain score will be assessed using Visual Analogue Scale:
- Anticipated pain or current pain before the intervention.
- Immediately after speculum insertion.
- Immediately after tenaculum placement.
- Immediately after uterine sounding.
- During or immediately after IUD insertion.
- Five minutes after the procedure
- Follow up at 3 and 6 months to assess women satisfaction with the method, menstrual pattern, symptoms of vaginal/pelvic infection Abdominal pain/tenderness Dyspareunia (woman/partner) Cramping or pregnancy.
- Vaginal examination to assess any infections or abnormalities and repeat ultrasound examination to assess the position of the IUD
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- IUCD insertion
| Arm | Type | Receives |
|---|---|---|
| IUD insertion | Experimental | Device: IUD insertionIUD insertion in women needing contraception |
Who may qualify
- Ages
- 20 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 20 -41 years
- BMI 18-25 kg/m2
- Women with any parity seeking contraception and choosing IUD as their preferred method after proper and thorough counseling
- Regularly menstruating women (duration of menstruation 3-7 days and length of cycle 22- 35 days).
- Not using any hormonal therapy or anticoagulation
Key exclusion criteria (13 listed)
- Cervical abnormalities.
- Pregnancy or suspicion of pregnancy
- Congenital or acquired uterine anomalies which distort the uterine cavity (fibroids, endometrial polyps, cervical stenosis, bicornuate uterus, hypoplastic uterus < 6 cm)
- Acute PID or a history of PID within the past 3 months
- Postpartum or post-abortion endometritis within the past 3 months
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 |
|---|---|---|
| IUD insertion* Perform a bimanual examination * Insert a warm, moistened speculum. * Cleanse the cervix with an antiseptic solution. * Open the sterile insertion instruments without touching * Remove the tenaculum by its handle and grasp the anterior or posterior lip of the cervix. * Apply gentle traction with the tenaculum to straighten the canal. * Remove the sound by its handle and gently insert it to measure the depth of the uterus. Do not apply great force if there is resistance. Apply further traction to the tenaculum and attempt to re-insert the sound at a different angle. Once the sound is inserted and removed * Open the IUD pack without touching its contents. * Put on sterile gloves. * Load the IUD and insert it into the uterine cavity according to the manufacturer instructions. * Gently remove the tenaculum. * Trim the strings of the IUD to 3-4 cm in length * Remove the speculum and assess the woman. | Device | IUD insertion |
Primary outcome
Failed IUD insertion
Time frame: 9 months
failure of IUD insertion
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 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for IUCD Complication
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Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7
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Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Primary Immune Deficiency Diseases
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A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
Endometrioid Endometrial Adenocarcinoma
Active, not recruitingPhase 2
Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer
Atypical Endometrial Hyperplasia, FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
Not yet recruitingEarly Phase 1
Tirzepatide and Levonorgestrel IUD Therapy for EIN and Early-Stage Endometrial Cancer
Grade 1 Endometrial Endometrioid Carcinoma, Endometrial Intraepithelial Neoplasia
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.
Ahmed Maged principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUD insertion in people with IUCD Complication, run by Cairo University at 1 site in Egypt.
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 13 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 31 Jul 2026. 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 Egypt. 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?
Failed IUD insertion (time frame: 9 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 31 Jul 2026.