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.

Launched by UNIVERSITY HOSPITAL, GHENT · Jan 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to insert a contraceptive device called GyneFix, using a tool called the ReLARC inserter. The goal is to see how safe this method is and to make sure the device is placed correctly inside the uterus. The trial will take place over three years in hospitals in Belgium and Italy, and it aims to gather information from 120 women.

To be eligible for the study, participants should be generally healthy women aged 18 to 48 who can attend follow-up appointments. They should not have any medical issues that would make the insertion unsafe, such as certain types of uterine shapes or infections. Participants will need to follow some guidelines after the procedure, like avoiding intercourse for two weeks and not using tampons for two months. If everything goes well, they will continue to be monitored for three years to ensure the device stays in the right place without causing any problems.

Gender

FEMALE

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