Evaluating a new method for inserting a copper intrauterine contraceptive device
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.
NA · University Hospital, Ghent · NCT05702281
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 48 Years |
| Sex | Female |
| Sponsor | University Hospital, Ghent (other) |
| Locations | 1 site (Ghent) |
| Trial ID | NCT05702281 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are generally healthy women aged 18 to 48 without contraindications for hysteroscopy.
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.
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 performed: While this approach is innovative, similar studies using hysteroscopic techniques for device insertion have shown promising results.
Eligibility criteria
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 this trial is running
Ghent
- University Hospital — Ghent, Belgium (RECRUITING)
Study contacts
- Study coordinator: Steven Weyers, MD
- Email: steven.weyers@uzgent.be
- Phone: 93327817
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Contraception, copper intra-uterine device, Hysteroscope