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.
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
T and Y shaped uterus
U1, dysmorphic uterus (abnormal myometrium may result in bad device fixation)
Complete septate U2b uterus
Bicorporal U3-U6 uterus
Single group
ReLARC
DeviceReLARC® 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.
Positioning of the ReLARC IUD
To evaluate the position of the ReLARC® IUD to confirm the succesful placement of the IUD with the ReLARC inserter during every follow-up visit.
Ease of insertion
1\. The ease of the insertion (hysteroscope and ReLARC® device) by the following scale: 1. Insertion went smoothly. 2. I had little trouble while inserting the device but experienced this as a not important delay in my surgical act. 3. Insertion was rather difficult. 4. Insertion was time consuming, difficult, and dangerous. 5. Insertion was not possible due to technical issues or medical reasons.
Learning curve of ReLARC insertion
2\. The learning curve of ReLARC® insertion, that starts after introducing the scope in the cervix and ends when the thread is cut and looped. This will be reported in minutes.
Pain score
the participant's pain by a Visual Analogue Scale-VAS (1. no pain, 2. mild pain, 3. nasty pain, 4. severe pain, 5. unbearable pain) will be described.
patient satisfactory
The patient satisfactory score will be determined at every follow-up visit (4-8 weeks after insertion; 1 year after insertion, 2 years after insertion and 3 years after insertion)
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University Hospital, Ghent
Lead sponsor
Federico II University
Collaborator
