Clinical Trials Logo

Clinical 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. Hysteroscopic insertion of the device allows direct visualization of the procedure, which makes it extremely safe. This multicentre, open-label study will take place in the Women's Clinic of the Ghent University Hospital in Belgium (International Coordinating Centre) and in 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.


Clinical Trial Description

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 in the Women's Clinic of the Ghent University Hospital in Belgium (International Coordinating Centre) and in 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. During the screeningsvisit the physician will introduce the trial. During the enrolment visit, the patient will sign the informed consent if she agrees to participate. During the insertion visit, the IUD will be placed, the correct location of the device will be determined, the ease of ReLARC insertion and hysteroscope insertion will be measured, the learning curve of the insertion will be registered and the pain score of the patient will be registered. After 4-8 weeks the first follow-up visit will take place. The location of the device will be determined and a satisfactory score of the patient about the IUD. During 3 years there's a yearly consultation with the gynaecologist where the location of the device and the satisfactory score about the IUD will be determined. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05702281
Study type Interventional
Source University Hospital, Ghent
Contact Steven Weyers, MD
Phone 93327817
Email steven.weyers@uzgent.be
Status Recruiting
Phase N/A
Start date May 1, 2022
Completion date December 31, 2027

See also
  Status Clinical Trial Phase
Completed NCT02577601 - Impact of Combined Hormonal Contraceptives on UPA Phase 4
Completed NCT03153644 - Improving Contraceptive Care for Women With Medical Conditions
Completed NCT04112095 - Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use Phase 3
Recruiting NCT05521646 - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative N/A
Active, not recruiting NCT04291001 - Ovarian Function With ENG Implant and UPA Use Early Phase 1
Completed NCT04568980 - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Completed NCT03438682 - Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Active, not recruiting NCT01948882 - Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women N/A
Enrolling by invitation NCT04997499 - Adolescent Subcutaneous (SQ) Injection Video Validation N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2
Completed NCT04463680 - Rifampin and the Contraceptive Implant Phase 4
Completed NCT03154125 - Sayana® Press Extension Study Phase 3
Withdrawn NCT03725358 - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon. N/A
Completed NCT02957630 - "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study" Phase 1/Phase 2
Completed NCT02718222 - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services N/A
Completed NCT02456584 - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods Phase 1
Recruiting NCT02121067 - LNG-IUS at 2 Weeks Postpartum Phase 4
Terminated NCT02169869 - Immediate Postplacental IUD Insertion N/A
Recruiting NCT02292056 - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions N/A
Withdrawn NCT01930994 - Kenya Sino-implant (II) PK Study N/A