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New handmade IUD aims to stay put in women with adenomyosis

NCT ID NCT07518693

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Oct 2024

Lead sponsor

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

25 to 55 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.