Clinical study of a frameless indomethacin-containing copper intrauterine device combined with levonorgestrel-releasing intrauterine system in the treatment of adenomyosis.

Authors

Tianlong Li, Jinxian Wei, Jijing Shi, Nana Hou, Miaomiao Zhang, Zilong Ma, Li Wang, Fangmei Liu, Xiaoru Li, Pengpeng Zhang, Lili Mao

Published in

Journal of minimally invasive gynecology. Oct 26, 2026. Epub Oct 26, 2026.

Abstract

To evaluate the safety and therapeutic efficacy of LNG-IUS alone versus LNG-IUS combined with frameless anchoring copper intrauterine device (IUD) (with or without indomethacin) in treating adenomyosis, and to explore the role of indomethacin in improving outcomes.
A prospective study was conducted on 91 adenomyosis patients at Zhengzhou First People's Hospital (January 2022-January 2025), divided into three groups: Group A received LNG-IUS monotherapy alone (n = 29); Group B was treated with LNG-IUS combined with GyneFix® (GyneFix IN), a drug-free frameless copper IUD without indomethacin (n = 30); Group C received LNG-IUS paired with Jenefox (Jinizhimei), an indomethacin-loaded frameless copper IUD (n = 32).Baseline data, adverse events (complete expulsion, downward displacement and Removal), and efficacy indicators (uterine volume, hemoglobin [HGB], pictorial blood loss assessment chart [PBAC] score, visual analogue scale [VAS] score) were monitored during 12 months of follow-up.
Single tertiary hospital gynecology department affiliated to Xinxiang Medical College, Zhengzhou, China.
Women aged 30-52 years with ultrasonically confirmed symptomatic diffuse adenomyosis without fertility demands were enrolled. All subjects declined hysterectomy and long-term systemic hormonal medication, and agreed to complete all scheduled follow-up examinations. Patients with congenital uterine malformations, submucous fibroids, recent pelvic inflammatory disease, coagulation disorders, severe uncontrolled systemic diseases, or malignant gynecologic lesions were excluded. A total of 91 patients were allocated into three groups by treatment preference: Group A (LNG-IUS alone, n=29), Group B (LNG-IUS + GyneFix®, n=30), Group C (LNG-IUS + Jenefox, n=32). Baseline demographic and clinical parameters were balanced across the three groups (all P>0.05).
Placement of standalone LNG-IUS, combined LNG-IUS with indomethacin-free frameless copper IUD, or combined LNG-IUS with indomethacin-containing frameless copper IUD under transabdominal ultrasound guidance. The LNG-IUS was ligated to the anchoring knot of frameless copper IUD to form a dual-device system, which was anchored into the uterine myometrium during insertion; diagnostic hysteroscopy was performed immediately after placement to inspect the uterine cavity in combined-device groups.
Baseline characteristics were comparable among groups. Group A had a 17.24% complete expulsion rate, while no complete expulsion/ downward displacement occurred in Groups B and C. Group C showed significantly smaller uterine volume than Groups A and B from 3 months onward (P<0.05). PBAC scores in Groups B and C were significantly lower than in Group A, with Group C exhibiting better improvement (P<0.05). Group C had lower VAS scores than A and B within 6 months (P<0.05), and Group B outperformed A at 12 months. Adverse events were mild and self-limiting; Group C had a lower irregular bleeding rate (3.13%) than Group A (10.34%) and no abdominal/back pain (P<0.05).
Within the 12-month follow-up of this single-center cohort, no complete IUD expulsion or severe uterine downward displacement occurred in Groups B and C, whereas the LNG-IUS monotherapy group had a complete expulsion rate of 17.24%. All three regimens improved uterine volume, hemoglobin, menstrual blood loss and dysmenorrhea, and Group C achieved the most pronounced reductions in uterine volume, PBAC and VAS scores, with the lowest rate of irregular bleeding. The dual-device regimens therefore represent promising uterus-sparing conservative options for adenomyosis patients at high risk of IUD expulsion.

PMID:
42933564
Bibliographic data and abstract were imported from PubMed on 27 Oct 2026.

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