ContraceptionReLARC - REL-0NCT05702281
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.
A study testing ReLARC in people with Contraception, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- ReLARC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital
Ghent, 9000
Eline Meireson, +32 9 332 78 17, eline.meireson@uzgent.be
About this study
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.
Read more
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.
- Conditions
- Contraception
- Being tested
- ReLARC
- Keywords
- copper intra-uterine device, Hysteroscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReLARCDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ReLARC 3 | Other | 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.
ReLARC® 3 is inserted through a hysteroscope (KARL STORZ HOPKINS® Wide Angle Straight Forward Telescope 6°, art. no. 26208AMA in combination with the irrigation pump Endomat® select). Receives: Device: ReLARC |
| ReLARC 10 | Other | 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.
ReLARC® 10 is inserted through a hysteroscope (KARL STORZ HOPKINS® Wide Angle Straight Forward Telescope 6°, art. no. 26208AMA in combination with the irrigation pump Endomat® select). Receives: Device: ReLARC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (9)
Ease of insertion
- The ease of the insertion (hysteroscope and ReLARC® device) by the following scale:
- Insertion went smoothly.
- I had little trouble while inserting the device but experienced this as a not important delay in my surgical act.
- Insertion was rather difficult.
- Insertion was time consuming, difficult, and dangerous.
- Insertion was not possible due to technical issues or medical reasons.
Measured: During Insertion visit
Learning curve of ReLARC insertion
- 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.
Measured: During Insertion visit
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.
Measured: During Insertion visit
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)
Measured: 3 years after insertion
Uterine cavity transverse diameter
the uterine cavity transverse diameter (UCTD) (before ReLARC® device insertion) will be described.
Measured: During insertion visit
Expulsion rate
The number of expulsions of the IUD will be registered during the trial
Measured: 7 years
Removal rate
The number of early removal of the IUD will be registered during the trial
Measured: 7 years
Ease of removal
The ease of removal (Likert scale): 1. very easy, 2. easy, 3. neither easy nor difficult, 4. difficult, 5. very difficult
Measured: 7 years
Pain at removal
pain (VAS): 1. no pain, 2. mild pain, 3. nasty pain, 4. severe pain, 5. unbearable pain
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702281
- Sponsor's protocol ID
- BC-09207
- Acronym
- ReLARC - REL-0
- Status last verified
- Sep 2026
- First submitted
- 22 Jun 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05702281
- Acronym / sponsor ID
- ReLARC - REL-0 / BC-09207
- Conditions
- Contraception
- Keywords
- copper intra-uterine device, Hysteroscope
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReLARC 3 | Other | Device: ReLARCReLARC® 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. ReLARC® 3 is inserted through a hysteroscope (KARL STORZ HOPKINS® Wide Angle Straight Forward Telescope 6°, art. no. 26208AMA in combination with the irrigation pump Endomat® select). |
| ReLARC 10 | Other | Device: ReLARCReLARC® 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. ReLARC® 10 is inserted through a hysteroscope (KARL STORZ HOPKINS® Wide Angle Straight Forward Telescope 6°, art. no. 26208AMA in combination with the irrigation pump Endomat® select). |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReLARCReLARC® 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. | Device | ReLARC 10, ReLARC 3 |
Primary outcome
Positioning of the ReLARC IUD
Time frame: 3 years
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.
9 secondary outcomes
Ease of insertion
Time frame: During Insertion visit
Learning curve of ReLARC insertion
Time frame: During Insertion visit
Pain score
Time frame: During Insertion visit
patient satisfactory
Time frame: 3 years after insertion
Uterine cavity transverse diameter
Time frame: During insertion visit
Expulsion rate
Time frame: 7 years
Removal rate
Time frame: 7 years
Ease of removal
Time frame: 7 years
Pain at removal
Time frame: 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReLARC in people with Contraception, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Weyers, MD (93327817 ext. 0032, steven.weyers@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positioning of the ReLARC IUD (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.