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.
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ReLARC.
- Who it may be relevant to
- Registry conditions: Contraception. Basic parameters: 18 years — 48 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Insertion under vision such as hysteroscopy allows the ability to visualize the uterus prior to insertion, to assess uterine compatibility and the assurance of proper device placement. ReLARC® is a GyneFix® device intended to be inserted via hysteroscopy. Hysteroscopic insertion of the device allows direct visualization of the procedure, which makes it extremely safe. This multicentre, open-label study will take place at the Women's Clinic of Ghent University Hospital in Belgium (International Coordinating Centre) and at the University Hospital AOU Federico II of Naples in Italy. Primary aim: To evaluate the safety of the ReLARC® inserter during the insertion procedure of GyneFix® intrauterine copper bearing contraceptive devices by means of successful placement with adequate position during follow-up evaluations. Providing no complications develop, participants will remain in the study for 3 years. 120 women will be enrolled.
Interventions
- Device ReLARC
ReLARC® is a GyneFix® device intended to be inserted via hysteroscopy. Hysteroscopic insertion of the device allows direct visualization of the procedure, which makes it extremely safe.
Primary outcome measures
- Positioning of the ReLARC IUD [Time frame: 3 years]
Secondary outcome measures (9)
- Ease of insertion [Time frame: During Insertion visit]
- Learning curve of ReLARC insertion [Time frame: During Insertion visit]
- Pain score [Time frame: During Insertion visit]
- patient satisfactory [Time frame: 3 years after insertion]
- Uterine cavity transverse diameter [Time frame: During insertion visit]
- Expulsion rate [Time frame: 7 years]
- Removal rate [Time frame: 7 years]
- Ease of removal [Time frame: 7 years]
- Pain at removal [Time frame: 7 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- University Hospital — Ghent
Identifiers
NCT: NCT05702281 · REL-005