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

NCT07518693 | Completed

• 2 other identifiers: BBSYIRB-2024-K55IRB-2024-K55
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrauterine Device Expulsion; Adenomyosis, Endometriosis; Menorrhagia, Dysmenorrhea; Abnormal Uterine Bleeding

Keywords

GyneFix-LNG-IUS; Frameless LNG-IUS; IUD expulsion; Adenomyosis; Menorrhagia; Retrospective study

Outcome Measures

Primary Outcomes (1)

• IUD Expulsion Rate

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

  12 months post-insertion

Secondary Outcomes (1)

• Clinical Efficacy

  12 months post-insertion

Study Arms (1)

High-Risk Patients with IUD Expulsion

Patients at high risk of IUD expulsion, including those with adenomyosis, uterine cavity enlargement, cervical laxity, or heavy menstrual bleeding, who received handmade frameless GyneFix-LNG-IUS placement.

Device: Handmade Frameless GyneFix-LNG-IUS

Interventions

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.

Also known as: GyneFix-LNG-IUS

High-Risk Patients with IUD Expulsion

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female patients aged 25-55 years at high risk of intrauterine device (IUD) expulsion, including those with adenomyosis, uterine cavity enlargement, cervical laxity, or heavy menstrual bleeding, who received handmade frameless GyneFix-LNG-IUS placement at The Third People's Hospital of Bengbu.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yu Wang: lead
• Zhejiang University: collaborator
• Women's Hospital School Of Medicine Zhejiang University: collaborator

Study Sites (1)

The Third People's Hospital of Bengbu

Bengbu, Anhui, 233000, China

Location

MeSH Terms

Conditions

Adenomyosis; Endometriosis; Menorrhagia; Dysmenorrhea; Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: February 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)