Intrauterine Device ExpulsionGyne-LNG-IUSNCT07518693
Clinical Observation of Hysteroscopy-Assisted Placement of Handmade Frameless GyneFix-LNG-IUS (Retrospective Cohort)
An observational study of Intrauterine Device Expulsion and Adenomyosis, Endometriosis, run by Yu Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Intrauterine Device Expulsion, Adenomyosis, Endometriosis, Menorrhagia, Dysmenorrhea
- What is being tested?
- Handmade Frameless GyneFix-LNG-IUS
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 Oct 2024
- Phase
- Observational
- 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 25 to 55 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnancy or lactation
- Severe systemic diseases
- Contraindications for intrauterine device placement
- Incomplete follow-up data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Handmade Frameless Levonorgestrel-Releasing Intrauterine System for Chinese Patients: A Retrospective Self-Controlled Observational Study
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
- Being tested
- Handmade Frameless GyneFix-LNG-IUS
- Keywords
- GyneFix-LNG-IUS, Frameless LNG-IUS, IUD expulsion, Adenomyosis, Menorrhagia, Retrospective study
- Medical subject headings
- Adenomyosis, Endometriosis, Menorrhagia, Dysmenorrhea, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handmade Frameless GyneFix-LNG-IUSDevice
Also called GyneFix-LNG-IUS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Handmade Frameless GyneFix-LNG-IUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
IUD Expulsion Rate
Rate of GyneFix-LNG-IUS expulsion during follow-up in high-risk patients with adenomyosis, uterine cavity enlargement, or cervical laxity.
Measured: 12 months post-insertion
Secondary outcomes (1)
Clinical Efficacy
Improvement of dysmenorrhea and abnormal uterine bleeding after GyneFix-LNG-IUS placement, evaluated by patient-reported symptoms and menstrual volume.
Measured: 12 months post-insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Feb 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Device ExpulsionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu Wang
- Sponsor type
- Other government
- Collaborators
- Zhejiang University, Women's Hospital School Of Medicine Zhejiang University
- Responsible party
- Sponsor-investigator, Yu Wang, The Third People's Hospital of Bengbu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518693
- Sponsor's protocol ID
- BBSYIRB-2024-K55
- Other IDs
- IRB-2024-K55
- Acronym
- Gyne-LNG-IUS
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handmade Frameless Levonorgestrel-Releasing Intrauterine System for Chinese Patients: A Retrospective Self-Controlled Observational Study
- ClinicalTrials.gov ID
- NCT07518693
- Acronym / sponsor ID
- Gyne-LNG-IUS / BBSYIRB-2024-K55
- Conditions
- Intrauterine Device Expulsion, Adenomyosis, Endometriosis, Menorrhagia, Dysmenorrhea, Abnormal Uterine Bleeding
- Keywords
- GyneFix-LNG-IUS, Frameless LNG-IUS, IUD expulsion, Adenomyosis, Menorrhagia, Retrospective study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yu WangOther government
- Collaborators
- Zhejiang University, Women's Hospital School Of Medicine Zhejiang University
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 8 Apr 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Risk Patients with IUD Expulsion | – | Device: Handmade Frameless GyneFix-LNG-IUSPatients 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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy or lactation
- Severe systemic diseases
- Contraindications for intrauterine device placement
- Incomplete follow-up data
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 |
|---|---|---|
| Handmade Frameless GyneFix-LNG-IUSAlso: GyneFix-LNG-IUSA 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. | Device | High-Risk Patients with IUD Expulsion |
Primary outcome
IUD Expulsion Rate
Time frame: 12 months post-insertion
Rate of GyneFix-LNG-IUS expulsion during follow-up in high-risk patients with adenomyosis, uterine cavity enlargement, or cervical laxity.
1 secondary outcome
Clinical Efficacy
Time frame: 12 months post-insertion
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 8 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Intrauterine Device Expulsion
Recruiting
Pilot Study of Suction as a Mechanism of IUD Expulsion With Concomitant Menstrual Cup Use
IUD; Complications, Mechanical, Menstrual Cup
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?
An observational study of Intrauterine Device Expulsion and Adenomyosis, Endometriosis, run by Yu Wang 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 4 inclusion and 4 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 8 Apr 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?
IUD Expulsion Rate (time frame: 12 months post-insertion). 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 8 Apr 2026.