Evaluating a new method for inserting a copper intrauterine contraceptive device
Official title: Evaluation of the Safety and Efficacy of the ReLARC Inserter During the Insertion Procedure of GYNEFIX Intrauterine Copper Bearing Contraceptive Device With a Follow-up of 3 Years.
Run by University Hospital, Ghent · NCT05702281 · Data updated 2026-11-12
This study is testing a new tool for safely and effectively placing a copper IUD in healthy women aged 18 to 48 to see if it works better than current methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 48 Years |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Status | Recruiting |
| Started | May 1, 2022 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT05702281 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are generally healthy women aged 18 to 48 without contraindications for hysteroscopy.
✕Probably not a fit
Patients with specific uterine abnormalities or infections, as well as those with a history of certain cancers, will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, open-label study aims to assess the safety and efficacy of the ReLARC inserter during the insertion of the GyneFix intrauterine copper-bearing contraceptive device. The procedure will be performed under hysteroscopic visualization, allowing for direct assessment of uterine compatibility and proper device placement. A total of 120 generally healthy women aged 18 to 48 will be enrolled, with follow-up evaluations conducted over a period of three years to monitor for complications and ensure successful placement.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of intrauterine contraceptive device insertions for women.
How similar studies have gone: While this approach is innovative, similar studies using hysteroscopic techniques for device insertion have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Generally healthy women, 18 - 48 years of age and not having a contraindication for hysteroscopy * Be willing to come back for the follow-ups * Be willing to refrain from having intercourse the first two weeks and using tampons and menstrual cups in the first 2 months, following insertion * Sign a written informed consent * Fundus thickness should be 11mm or more Exclusion Criteria: * T and Y shaped uterus * U1, dysmorphic uterus (abnormal myometrium may result in bad device fixation) * Complete septate U2b uterus * Bicorporal U3-U6 uterus * Injectables contraceptive use in the last 6 months * The presence of infection of the uterus, clinical cervicitis or vaginitis (infection should be ruled out) * Intrauterine fibroids (intra-mural, intracavitary or submucosal) * Cancer or other disease of the uterus * Malignancy, or treatment for malignancy. Melanoma or any gynaecological cancer at any time excludes the subject * Blood clotting disorders * Intrauterine polyps * Subjects receiving corticosteroid therapy or immunosuppressive drugs * Morbus Wilson * AIDS * Pregnancy
Where it's running
-
University Hospital
Ghent, Belgium Recruiting
Study contacts
- Study coordinator: Steven Weyers, MD
- Email: steven.weyers@uzgent.be
- Phone: 93327817
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.