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.

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.

Inclusion Criteria:Generally healthy women, 18 - 48 years of age and not having a contraindication for hysteroscopyBe willing to come back for the follow-upsBe willing to refrain from having intercourse the first week and using tampons and menstrual cups in the first 2 months, following insertionSign a written informed consentFundus thickness should be 11mm or moreExclusion Criteria:T and Y shaped uterusU1, dysmorphic uterus (abnormal myometrium may result in bad device fixation)Complete septate U2b uterusBicorporal U3-U6 uterusInjectables contraceptive use in the last yearThe 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 uterusMalignancy, or treatment for malignancy. Melanoma or any gynaecological cancer at any time excludes the subjectBlood clotting disordersIntrauterine polypsThrombophlebitis, thrombosis, or thromboembolic disordersCerebrovascular accident, stroke, or transient ischemic attackAny cardiac, renal, or hepatic diseaseSubjects receiving corticosteroid therapy or immunosuppressive drugsMorbus WilsonAIDS