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Completed

NCT Number: NCT07518693

Clinical Observation of Hysteroscopy-Assisted Placement of Handmade Frameless GyneFix-LNG-IUS (Retrospective Cohort)

This is a retrospective self-controlled observational study. We evaluated the safety and efficacy of a handmade frameless levonorgestrel-releasing intrauterine system (GyneFix-LNG-IUS) in patients at high risk of IUD expulsion. The device was constructed by combining the GyneFix IUD anchor system and a conventional LNG-IUS with the T-shaped arms removed. All data were collected from routine clinical records. The primary outcome was device expulsion or migration during follow-up.

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Key information

Conditions

Intrauterine Device Expulsion Abnormal Uterine Bleeding Adenomyosis Adenomyosis, Endometriosis Dysmenorrhea Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menorrhagia Menorrhagia, Dysmenorrhea Menstruation Disturbances Metrorrhagia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

25 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

The Third People's Hospital of Bengbu

Bengbu, Anhui, 233000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients aged 25-55 years
  • High risk of IUD expulsion, including adenomyosis, uterine cavity enlargement, cervical laxity, or heavy menstrual bleeding
  • Received handmade frameless GyneFix-LNG-IUS placement
  • Complete clinical follow-up data available

Exclusion criteria

  • Pregnancy or lactation
  • Severe systemic diseases
  • Contraindications for intrauterine device placement
  • Incomplete follow-up data

Treatment and study plan

Handmade Frameless GyneFix-LNG-IUS

Device

A handmade frameless levonorgestrel-releasing intrauterine system, constructed by combining the GyneFix IUD anchor system and a conventional LNG-IUS with the T-shaped arms removed, for placement in high-risk patients to reduce IUD expulsion.

Other names: GyneFix-LNG-IUS

Primary outcomes

  1. IUD Expulsion Rate

    Time frame: 12 months post-insertion

    Rate of GyneFix-LNG-IUS expulsion during follow-up in high-risk patients with adenomyosis, uterine cavity enlargement, or cervical laxity.

Secondary outcomes

  1. Clinical Efficacy

    Time frame: 12 months post-insertion

    Improvement of dysmenorrhea and abnormal uterine bleeding after GyneFix-LNG-IUS placement, evaluated by patient-reported symptoms and menstrual volume.

Sponsors and collaborators

Lead sponsor

Yu Wang

Other

Collaborators

  • Women's Hospital School Of Medicine Zhejiang University
  • Zhejiang University

Registry information

Official study title

Handmade Frameless Levonorgestrel-Releasing Intrauterine System for Chinese Patients: A Retrospective Self-Controlled Observational Study

Acronym: Gyne-LNG-IUS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

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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