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NCT Number: 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.

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.

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Key information

Conditions

Contraception

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ReLARC

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Ease of insertion

    Time frame: During Insertion visit

    • 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.

  2. Learning curve of ReLARC insertion

    Time frame: During Insertion visit

    • 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.

  3. Pain score

    Time frame: During Insertion visit

    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.

  4. patient satisfactory

    Time frame: 3 years after insertion

    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)

  5. Uterine cavity transverse diameter

    Time frame: During insertion visit

    the uterine cavity transverse diameter (UCTD) (before ReLARC® device insertion) will be described.

  6. Expulsion rate

    Time frame: 7 years

    The number of expulsions of the IUD will be registered during the trial

  7. Removal rate

    Time frame: 7 years

    The number of early removal of the IUD will be registered during the trial

  8. Ease of removal

    Time frame: 7 years

    The ease of removal (Likert scale): 1. very easy, 2. easy, 3. neither easy nor difficult, 4. difficult, 5. very difficult

  9. Pain at removal

    Time frame: 7 years

    pain (VAS): 1. no pain, 2. mild pain, 3. nasty pain, 4. severe pain, 5. unbearable pain

Study contacts

Contact information is provided by the study sponsor or research team.

Eline Meireson, Msc

CONTACT

[email protected]

09 332 78 17 ext. 0032

Steven Weyers, MD

CONTACT

[email protected]

93327817 ext. 0032

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Federico II University

Registry information

Acronym: ReLARC

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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