AdenomyosisGYNEFIX-AMNCT07680985
GyneFix IUD Plus LNG-IUS for Adenomyosis
A study testing Indomethacin-GyneFix IUD Plus LNG-IUS, Ring IUD Plus LNG-IUS and LNG-IUS Alone in people with Adenomyosis, run by Wenzhou People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Indomethacin-GyneFix IUD Plus LNG-IUS, Ring IUD Plus LNG-IUS and LNG-IUS Alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy and Safety of Indomethacin-GyneFix IUD Combined With a Levonorgestrel-Releasing Intrauterine System in Patients With Adenomyosis and Different Uterine Cavity Depths
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.
Read the detailed description
This was a single-center, prospective, parallel-group, randomized controlled trial conducted at Wenzhou People's Hospital in patients with adenomyosis. The study was designed to compare three intrauterine treatment strategies for improving the stability of a levonorgestrel-releasing intrauterine system in patients with different uterine cavity depths.
Eligible patients were women diagnosed with adenomyosis who had no current desire for pregnancy, had no contraindications to intrauterine device placement, and were able to complete scheduled follow-up. After written informed consent was obtained, participants were randomly assigned in a 1:1:1 ratio to one of three groups: GyneFix IUD plus LNG-IUS, ring IUD plus LNG-IUS, or LNG-IUS alone.
In the GyneFix IUD plus LNG-IUS group, the Indomethacin-GyneFix IUD was used as an anchoring device to stabilize the LNG-IUS. The anchoring knot of the GyneFix IUD was placed in the uterine fundal myometrium under ultrasound guidance, allowing the LNG-IUS to remain suspended and stabilized within the uterine cavity. In the ring IUD plus LNG-IUS group, a ring IUD was placed together with the LNG-IUS to provide passive mechanical support. In the LNG-IUS-alone group, the LNG-IUS was inserted according to the standard procedure.
All procedures were performed under real-time ultrasound guidance by experienced gynecologists. Participants were followed at approximately 1 month, 3 months, and 6 months after device placement. Follow-up assessments included symptom evaluation, gynecological examination, ultrasound assessment of device position and uterine parameters, laboratory testing, adverse event monitoring, and treatment acceptance assessment.
The primary outcome was intrauterine device displacement or expulsion at 6 months. Secondary outcomes included changes in dysmenorrhea measured by visual analogue scale, menstrual blood loss measured by pictorial blood loss assessment chart, uterine volume, hemoglobin, serum CA125, adverse events, and patient acceptance. A subgroup analysis was planned according to uterine cavity depth.
- Conditions
- Adenomyosis
- Being tested
- Indomethacin-GyneFix IUD Plus LNG-IUS, Ring IUD Plus LNG-IUS, LNG-IUS Alone
- 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
- Medical subject headings
- Adenomyosis, Dysmenorrhea, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin-GyneFix IUD Plus LNG-IUSDevice
Also called GyneFix IUD Plus LNG-IUS, GyneFix IUD Combined With LNG-IUS, Mirena Plus GyneFix IUD
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.
Ring IUD Plus LNG-IUSDevice
Also called Ring IUD Combined With LNG-IUS, LNG-IUS Plus Ring IUD, Support-Based IUD Fixation
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.
LNG-IUS AloneDevice
Also called Levonorgestrel-Releasing Intrauterine System, Mirena, LNG-IUS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: LNG-IUS Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after device placement
Secondary outcomes (7)
Change From Baseline in Dysmenorrhea VAS Score
Change in dysmenorrhea severity measured by the visual analogue scale. The VAS score ranges from 0 to 10, with higher scores indicating more severe pain.
Measured: Baseline, 1 month, 3 months, and 6 months after device placement
Change From Baseline in PBAC Score
Change in menstrual blood loss measured by the pictorial blood loss assessment chart. Higher PBAC scores indicate greater menstrual blood loss.
Measured: Baseline, 1 month, 3 months, and 6 months after device placement
Change From Baseline in Uterine Volume
Change in uterine volume measured by gynecological ultrasound. Uterine volume was calculated using three-dimensional uterine measurements.
Measured: Baseline, 3 months, and 6 months after device placement
Change From Baseline in Hemoglobin Level
Change in hemoglobin level measured from venous blood samples to evaluate improvement in anemia associated with heavy menstrual bleeding.
Measured: Baseline, 3 months, and 6 months after device placement
Change From Baseline in Serum CA125 Level
Change in serum cancer antigen 125 level measured by laboratory testing. CA125 was used as an indirect marker of adenomyosis disease activity.
Measured: Baseline, 3 months, and 6 months after device placement
Incidence of Adverse Events
Incidence of adverse events during follow-up, including irregular vaginal bleeding, low back pain, lower abdominal discomfort, increased vaginal discharge, pelvic inflammatory disease, ovarian cysts, breast tenderness, acne, weight gain, device removal for symptoms, uterine perforation, device displacement, and device expulsion.
Measured: Up to 6 months after device placement
Treatment Acceptance at 6 Months
Treatment acceptance assessed by questionnaire at 6 months, including willingness to choose the same treatment again and willingness to recommend the treatment to others with similar conditions.
Measured: 6 months after device placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start20 Jul 2023
- Primary completion30 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peipei Li, Wenzhou People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680985
- Sponsor's protocol ID
- WPH-KY-2023-200
- Acronym
- GYNEFIX-AM
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study may be made available from the corresponding author upon reasonable request, after publication and subject to approval by the study investigators and applicable institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Indomethacin-GyneFix IUD Combined With a Levonorgestrel-Releasing Intrauterine System in Patients With Adenomyosis and Different Uterine Cavity Depths
- ClinicalTrials.gov ID
- NCT07680985
- Acronym / sponsor ID
- GYNEFIX-AM / WPH-KY-2023-200
- Conditions
- Adenomyosis
- Keywords
- GyneFix IUD, Indomethacin-GyneFix IUD, Levonorgestrel-Releasing Intrauterine System, LNG-IUS, Intrauterine Device Displacement, Intrauterine Device Expulsion, Uterine Cavity Depth, Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Wenzhou People's HospitalUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a single-center, prospective, parallel-group, randomized controlled trial conducted at Wenzhou People's Hospital in patients with adenomyosis. The study was designed to compare three intrauterine treatment strategies for improving the stability of a levonorgestrel-releasing intrauterine system in patients with different uterine cavity depths.
Eligible patients were women diagnosed with adenomyosis who had no current desire for pregnancy, had no contraindications to intrauterine device placement, and were able to complete scheduled follow-up. After written informed consent was obtained, participants were randomly assigned in a 1:1:1 ratio to one of three groups: GyneFix IUD plus LNG-IUS, ring IUD plus LNG-IUS, or LNG-IUS alone.
In the GyneFix IUD plus LNG-IUS group, the Indomethacin-GyneFix IUD was used as an anchoring device to stabilize the LNG-IUS. The anchoring knot of the GyneFix IUD was placed in the uterine fundal myometrium under ultrasound guidance, allowing the LNG-IUS to remain suspended and stabilized within the uterine cavity. In the ring IUD plus LNG-IUS group, a ring IUD was placed together with the LNG-IUS to provide passive mechanical support. In the LNG-IUS-alone group, the LNG-IUS was inserted according to the standard procedure.
All procedures were performed under real-time ultrasound guidance by experienced gynecologists. Participants were followed at approximately 1 month, 3 months, and 6 months after device placement. Follow-up assessments included symptom evaluation, gynecological examination, ultrasound assessment of device position and uterine parameters, laboratory testing, adverse event monitoring, and treatment acceptance assessment.
The primary outcome was intrauterine device displacement or expulsion at 6 months. Secondary outcomes included changes in dysmenorrhea measured by visual analogue scale, menstrual blood loss measured by pictorial blood loss assessment chart, uterine volume, hemoglobin, serum CA125, adverse events, and patient acceptance. A subgroup analysis was planned according to uterine cavity depth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GyneFix IUD Plus LNG-IUS | Experimental | Device: Indomethacin-GyneFix IUD Plus LNG-IUSParticipants 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. |
| Ring IUD Plus LNG-IUS | Active comparator | Device: Ring IUD Plus LNG-IUSParticipants 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. |
| LNG-IUS Alone | Active comparator | Device: LNG-IUS AloneParticipants 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indomethacin-GyneFix IUD Plus LNG-IUSAlso: GyneFix IUD Plus LNG-IUS, GyneFix IUD Combined With LNG-IUS, Mirena Plus GyneFix IUDThe 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. | Device | GyneFix IUD Plus LNG-IUS |
| Ring IUD Plus LNG-IUSAlso: Ring IUD Combined With LNG-IUS, LNG-IUS Plus Ring IUD, Support-Based IUD FixationThe 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. | Device | Ring IUD Plus LNG-IUS |
| LNG-IUS AloneAlso: Levonorgestrel-Releasing Intrauterine System, Mirena, LNG-IUSThe 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. | Device | LNG-IUS Alone |
Primary outcome
Device Displacement or Expulsion Rate at 6 Months
Time frame: 6 months after device placement
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.
7 secondary outcomes
Change From Baseline in Dysmenorrhea VAS Score
Time frame: Baseline, 1 month, 3 months, and 6 months after device placement
Change From Baseline in PBAC Score
Time frame: Baseline, 1 month, 3 months, and 6 months after device placement
Change From Baseline in Uterine Volume
Time frame: Baseline, 3 months, and 6 months after device placement
Change From Baseline in Hemoglobin Level
Time frame: Baseline, 3 months, and 6 months after device placement
Change From Baseline in Serum CA125 Level
Time frame: Baseline, 3 months, and 6 months after device placement
Incidence of Adverse Events
Time frame: Up to 6 months after device placement
Treatment Acceptance at 6 Months
Time frame: 6 months after device placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study may be made available from the corresponding author upon reasonable request, after publication and subject to approval by the study investigators and applicable institutional requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indomethacin-GyneFix IUD Plus LNG-IUS, Ring IUD Plus LNG-IUS and LNG-IUS Alone in people with Adenomyosis, run by Wenzhou People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Displacement or Expulsion Rate at 6 Months (time frame: 6 months after device placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.