Clinical trial NCT05702281: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Contraception
Keywords: copper intra-uterine device
Hysteroscope
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Federico II University
First posted: 2023-01-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Positioning of the ReLARC IUD
timeFrame: 3 years
Secondary outcomes:
measure: Ease of insertion
timeFrame: During Insertion visit
measure: Learning curve of ReLARC insertion
timeFrame: During Insertion visit
measure: Pain score
timeFrame: During Insertion visit
measure: patient satisfactory
timeFrame: 3 years after insertion
measure: Uterine cavity transverse diameter
timeFrame: During insertion visit
measure: Expulsion rate
timeFrame: 7 years
measure: Removal rate
timeFrame: 7 years
measure: Ease of removal
timeFrame: 7 years
measure: Pain at removal
timeFrame: 7 years
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital
Study officials:
References: