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A Randomized Controlled Trial of a Novel Hysteroscopic Fixation Method for LNG-IUD Placement

A Randomized Controlled Trial of a Novel Hysteroscopic Fixation Method for LNG-IUD Placement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102725
Enrollment
Unknown
Registered
2025-05-19
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menorrhagia (heavy menstrual bleeding)

Interventions

Hysteroscopic LNG-IUS insertion:LNG-IUS insertion during hysteroscopic surgery
LNG-IUS suture fixation group:Hysteroscopic suture fixation of LNG-IUS

Sponsors

The international peace maternity and child health hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Patients requiring hysteroscopic intervention for: 1. Menorrhagia (refractory to medical therapy) ;2.Endometrial hyperplasia (without atypia);3. Endometrial polyps;4. Abnormal uterine bleeding; 2.Patients desiring long-acting reversible contraception during the therapeutic procedure; 3. Patients with uterine length of >= 7cm or uterine cavity depth of >= 9cm in previous uterine surgery, patients with dysmenorrhea, cervical relaxation, and history of Mirena detachment;

Exclusion criteria

Exclusion criteria: 1.Confirmed or suspected pregnancy; 2.Concurrent gynecological malignancies; 3.Uterine malformations; 4.Active lower genital tract infections; 5.Progestin-dependent neoplasms; 6.Contraindications to hysteroscopic procedures; 7.Contraindications to anesthesia; 8.Suspicious malignant lesions detected during hysteroscopy; 9.Severe systemic comorbidities; 10.Known hypersensitivity to levonorgestrel or any excipients of LNG-IUS;

Design outcomes

Primary

MeasureTime frame
LNG-IUS expulsion rat;

Secondary

MeasureTime frame
Dysmenorrhea;Patient satisfaction;Incidence of postoperative complications;Menstrual blood loss;LNG-IUS expulsion rat;Quality of life;

Countries

China

Contacts

Public ContactShujun Gao

The international peace maternity and child health hospital

shujun_gao@shsmu.edu.cn+86 13162239413

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026