Evaluation of the Safety and Placement of the ReLARC Inserter During Insertion of the GyneFix Intrauterine Copper Device with 3-Year Follow-Up

What this Trial Is About

Researchers are evaluating the safety and performance of the ReLARC® inserter for placing the GyneFix® intrauterine copper contraceptive device. This device is designed to be inserted using hysteroscopy, which allows doctors to see inside the uterus during the procedure. This study is open-label and will enroll 120 healthy women aged 18 to 48 years who do not have contraindications for hysteroscopy. The goal is to confirm that the device is placed correctly and remains in proper position over a follow-up period of three years. Participants will have the ReLARC® device inserted under direct vision via hysteroscopy, which helps ensure safe and accurate placement. After the insertion procedure, women will be followed for three years to monitor the device's position and any complications. The study is being conducted at two centers: the Women's Clinic of Ghent University Hospital in Belgium and the University Hospital AOU Federico II of Naples in Italy. During the study, participants will return for follow-up visits to assess the device's placement and safety. Researchers will monitor the uterine compatibility and ensure no infections or adverse effects occur. Women will also be asked to avoid intercourse for the first two weeks and not use tampons or menstrual cups for the first two months after insertion. The main outcome measured is the correct positioning of the ReLARC IUD over the three-year period.

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.