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Timing your IUD insertion could prevent ovarian cysts

NCT ID NCT07248553

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is looking at 60 women who are getting a hormone-releasing IUD (LNG-IUD) to see if the timing of insertion during their menstrual cycle affects whether they develop ovarian cysts. Researchers will use ultrasound to check for cysts at 0, 3, 6, and 12 months after insertion. The goal is to find the best time to insert the IUD to lower the chance of cysts forming.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Levonorgestrel-containing intrauterine device (LNG-IUD)
What this could lead to
If successful, this could help doctors choose the best time to insert an LNG-IUD to reduce the chance of ovarian cysts forming.
What could go wrong
This is a small observational study, not a treatment trial. It may not find a clear link, and results may not apply to all women.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

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

The study population will consist of women aged 18 to 45 years who are clinically indicated for levonorgestrel-releasing intrauterine device (LNG-IUD) insertion for contraception or therapeutic purposes. Participants will be recruited from the outpatient gynecology clinic of SBÜ Gaziosmanpaşa Training and Research Hospital. All participants will have regular menstrual cycles and no contraindications to LNG-IUD use. They will be assigned to one of four observational cohorts (early follicular, late follicular, early luteal, or late luteal phase) according to the menstrual phase at the time of insertion.

Ages

18 to 45 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: * Reproductive age: 18-45 years * Patients with indications for LNG-IUD (levonorgestrel-containing intrauterine device) insertion (abnormal uterine bleeding, menorrhagia, dysmenorrhea, endometriosis, adenomyosis, hormonally induced dysfunctional uterine bleeding, endometrial protection in women receiving postmenopausal hormone replacement therapy, and endouterine hyperplasia without atypia) * Patients without contraindications for LNG-IUD (no suspected pregnancy, no serious uterine anomalies (Müllerian anomalies), no active pelvic infection, no history of serious liver disease or breast cancer, and no anatomical or clinical contraindications to IUD insertion) will be included. * They must not have used oral contraceptives for at least 3 months. * The previous IUD must have been removed at least 1 year prior. * Those who signed the informed consent form and agreed to participate voluntarily will be included in the study. * Those who have not used steroidal anti-inflammatory drugs within 24 hours of insertion of a levonorgestrel-containing IUD will be included in the study. Exclusion Criteria: * Pregnancy history or current pregnancy * Patients using hormone therapy * Patients with adnexal masses * Patients with severe systemic diseases (uncontrolled diabetes, advanced cardiovascular disease, active malignancies (especially hormone-sensitive ones), advanced liver or kidney failure, systemic connective tissue diseases) * Patients with contraindications to the levonorgestrel IUD (suspected pregnancy, severe uterine anomaly, active pelvic infection, severe liver disease, or a history of breast cancer, anatomical or clinical obstacles to intrauterine device insertion) * Patients with psychological disabilities * Patients who refuse to sign the informed consent form * Patients who cannot be followed up will not be included in the study.

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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.

How to take part

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  1. The places running it

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  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • SBÜ Gaziosmanpaşa Training and Research Hospital

    RECRUITING

    Gaziosmanpaşa, Outside of the US, 33400, Turkey (Türkiye)

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