New handmade IUD aims to stay put in women with adenomyosis
NCT ID NCT07518693
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a handmade frameless IUD that releases the hormone levonorgestrel in 15 women at high risk of IUD expulsion due to conditions like adenomyosis or heavy bleeding. The device was made by combining an anchor system with a standard IUD after removing its T-shaped arms. Researchers looked at how often the device fell out and whether it improved symptoms like pain and heavy periods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Levonorgestrel-releasing intrauterine system (handmade frameless GyneFix-LNG-IUS)
- What this could lead to
- If successful, this device could offer a better option for women at high risk of IUD expulsion, helping control heavy bleeding and pain without the device falling out.
- What could go wrong
- This is a very small, retrospective study with only 15 participants, so results may not apply to everyone. The device is handmade, which could affect consistency and safety.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
15 people
The number who actually took part.
- Started
-
Feb 2024
- Finished
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Oct 2024
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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25 to 55 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female patients aged 25-55 years 2. High risk of IUD expulsion, including adenomyosis, uterine cavity enlargement, cervical laxity, or heavy menstrual bleeding 3. Received handmade frameless GyneFix-LNG-IUS placement 4. Complete clinical follow-up data available Exclusion Criteria: 1. Pregnancy or lactation 2. Severe systemic diseases 3. Contraindications for intrauterine device placement 4. Incomplete follow-up data
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The Third People's Hospital of Bengbu
Bengbu, Anhui, 233000, China
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