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 in the Women's Clinic of the Ghent University Hospital in Belgium (International Coordinating Centre) and in 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.
Description
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 in the Women's Clinic of the Ghent University Hospital in Belgium (International Coordinating Centre) and in 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. During the screeningsvisit the physician will introduce the trial. During the enrolment visit, the patient will sign the informed consent if she agrees to participate. During the insertion visit, the IUD will be placed, the correct location of the device will be determined, the ease of ReLARC insertion and hysteroscope insertion will be measured, the learning curve of the insertion will be registered and the pain score of the patient will be registered.
After 4-8 weeks the first follow-up visit will take place. The location of the device will be determined and a satisfactory score of the patient about the IUD. During 3 years there's a yearly consultation with the gynaecologist where the location of the device and the satisfactory score about the IUD will be determined.
Eligibility
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 year
- 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
- Thrombophlebitis, thrombosis, or thromboembolic disorders
- Cerebrovascular accident, stroke, or transient ischemic attack
- Any cardiac, renal, or hepatic disease
- Subjects receiving corticosteroid therapy or immunosuppressive drugs
- Morbus Wilson
- AIDS