GyneFix IUD Plus LNG-IUS for Adenomyosis

NCT07680985 | Completed

• 1 other identifier: WPH-KY-2023-200
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Adenomyosis is a common gynecological condition that can cause menstrual pain, heavy menstrual bleeding, anemia, and reduced quality of life. The levonorgestrel-releasing intrauterine system is commonly used as a conservative treatment, but displacement or expulsion of the device may occur, especially in patients with an enlarged uterus or a deep uterine cavity. This study evaluated whether combining an Indomethacin-GyneFix intrauterine device with a levonorgestrel-releasing intrauterine system could improve device stability in patients with adenomyosis. Eligible participants were randomly assigned to receive GyneFix IUD plus LNG-IUS, ring IUD plus LNG-IUS, or LNG-IUS alone. Participants were followed for 6 months after device placement. The main outcome was device displacement or expulsion at 6 months. Other outcomes included menstrual pain, menstrual blood loss, uterine volume, hemoglobin, CA125, adverse events, and treatment acceptance.

Conditions

Adenomyosis

Keywords

GyneFix IUD; Indomethacin-GyneFix IUD; Levonorgestrel-Releasing Intrauterine System; LNG-IUS; Intrauterine Device Displacement; Intrauterine Device Expulsion; Uterine Cavity Depth; Dysmenorrhea; Heavy Menstrual Bleeding; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Device Displacement or Expulsion Rate at 6 Months

  The proportion of participants with intrauterine device displacement or expulsion at 6 months after device placement. Device displacement or expulsion was assessed by gynecological examination and ultrasound evaluation according to predefined criteria for intrauterine device position.

  6 months after device placement

Secondary Outcomes (7)

• Change From Baseline in Dysmenorrhea VAS Score

  Baseline, 1 month, 3 months, and 6 months after device placement

• Change From Baseline in PBAC Score

  Baseline, 1 month, 3 months, and 6 months after device placement

• Change From Baseline in Uterine Volume

  Baseline, 3 months, and 6 months after device placement

• Change From Baseline in Hemoglobin Level

  Baseline, 3 months, and 6 months after device placement

• Change From Baseline in Serum CA125 Level

  Baseline, 3 months, and 6 months after device placement

Study Arms (3)

GyneFix IUD Plus LNG-IUS

EXPERIMENTAL

Participants received Indomethacin-GyneFix IUD combined with a levonorgestrel-releasing intrauterine system. The GyneFix IUD was used as an anchoring device to stabilize the LNG-IUS. Under real-time ultrasound guidance, the anchoring knot of the GyneFix IUD was implanted into the uterine fundal myometrium, allowing the LNG-IUS to remain suspended and stabilized within the uterine cavity.

Device: Indomethacin-GyneFix IUD Plus LNG-IUS

Ring IUD Plus LNG-IUS

ACTIVE COMPARATOR

Participants received a ring IUD combined with a levonorgestrel-releasing intrauterine system. The ring IUD and LNG-IUS were sequentially inserted into the uterine cavity under ultrasound guidance. The ring IUD was positioned near the upper uterine cavity or fundal region to provide passive mechanical support for the LNG-IUS.

Device: Ring IUD Plus LNG-IUS

LNG-IUS Alone

ACTIVE COMPARATOR

Participants received LNG-IUS alone. The levonorgestrel-releasing intrauterine system was inserted according to the standard procedure under ultrasound guidance, with the transverse arms fully extended and the device positioned at the uterine fundus.

Device: LNG-IUS Alone

Interventions

Indomethacin-GyneFix IUD Plus LNG-IUS DEVICE

The Indomethacin-GyneFix IUD was used as an anchoring device to stabilize the levonorgestrel-releasing intrauterine system. The LNG-IUS was connected to the upper portion of the GyneFix IUD with non-absorbable surgical suture. Under real-time ultrasound guidance, the anchoring knot of the GyneFix IUD was implanted into the uterine fundal myometrium, allowing the LNG-IUS to remain suspended and stabilized within the uterine cavity.

Also known as: GyneFix IUD Plus LNG-IUS, GyneFix IUD Combined With LNG-IUS, Mirena Plus GyneFix IUD

GyneFix IUD Plus LNG-IUS

Ring IUD Plus LNG-IUS DEVICE

The ring IUD and the levonorgestrel-releasing intrauterine system were sequentially inserted into the uterine cavity under real-time ultrasound guidance. The ring IUD was positioned near the upper uterine cavity or fundal region to provide passive mechanical support for the LNG-IUS. The LNG-IUS was then released in the conventional manner with its transverse arms extended.

Also known as: Ring IUD Combined With LNG-IUS, LNG-IUS Plus Ring IUD, Support-Based IUD Fixation

Ring IUD Plus LNG-IUS

LNG-IUS Alone DEVICE

The levonorgestrel-releasing intrauterine system was inserted according to the standard procedure under real-time ultrasound guidance. Correct placement required full extension of the transverse arms and positioning of the device at the uterine fundus.

Also known as: Levonorgestrel-Releasing Intrauterine System, Mirena, LNG-IUS

LNG-IUS Alone

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged 20 to 55 years.
• Diagnosed with adenomyosis by transvaginal ultrasound.
• No current desire for pregnancy and willing to receive conservative intrauterine treatment.
• No contraindications to intrauterine device placement.
• Able to understand the study procedures and voluntarily provide written informed consent.
• Able and willing to comply with scheduled follow-up visits and study assessments.

You may not qualify if:

• Pregnancy or suspected pregnancy.
• Concurrent malignant tumor of the reproductive system.
• Severe cervical lesions or uterine malformations.
• Severe coagulation disorder.
• Severe hepatic or renal insufficiency.
• Known hypersensitivity to levonorgestrel, copper, indomethacin, or related device components.
• Uncontrolled pelvic inflammatory disease or untreated vaginal infection.
• Uterine prolapse grade II or higher.
• Any condition judged by the investigator to make intrauterine device placement unsuitable.
• Inability to complete follow-up or incomplete key clinical data.
• Withdrawal of consent during the study.

Sponsors & Collaborators

• Wenzhou People's Hospital: lead

Study Sites (1)

Wenzhou People's Hospital

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Adenomyosis; Dysmenorrhea; Menorrhagia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Complete masking of participants and treating gynecologists was not fully feasible because the interventions involved different intrauterine device configurations and placement procedures. Postoperative outcome assessors who collected follow-up symptom assessments, satisfaction questionnaires, and medical record data were blinded to treatment allocation. Statisticians analyzed coded group labels. Ultrasound physicians were not masked because the device type was identifiable on imaging.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This was a three-arm, parallel-assignment, randomized controlled trial. Eligible participants with adenomyosis were randomly assigned in a 1:1:1 ratio to receive GyneFix IUD plus LNG-IUS, ring IUD plus LNG-IUS, or LNG-IUS alone, with follow-up assessments conducted for 6 months after device placement.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: July 20, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning after publication with no fixed end date.
• Access Criteria: Researchers with a scientifically sound proposal may request access to de-identified data. Requests will be reviewed by the corresponding author and study investigators, and data sharing will be subject to ethics, privacy, and institutional requirements.

Locations

CN (1)