Timing of levonorgestrel IUD placement and ovarian cysts
Official title: The Effect of Levonorgestrel-Containing Intrauterine Device (LNG-IUD) Insertion Timing on Ovarian Cyst Development According to the Early and Late Follicular and Luteal Phases
Run by Gaziosmanpasa Research and Education Hospital · NCT07248553 · Data updated 2026-11-12
This study will see if placing a levonorgestrel (LNG) IUD at different parts of the menstrual cycle changes the chance of ovarian cysts in women aged 18–45.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Locations | 1 site (Gaziosmanpaşa, Outside of the US) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | November 25, 2025 |
| Trial ID | NCT07248553 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women 18–45 with an indication for a levonorgestrel IUD, no contraindications, who have not used oral contraceptives for at least 3 months and who agree to follow-up imaging are ideal candidates.
✕Probably not a fit
Women outside the 18–45 age range, with contraindications to LNG-IUD, recent steroidal contraceptive use, a prior IUD removed less than one year ago, or who cannot attend follow-up visits are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In a prospective observational design, women aged 18–45 receiving a levonorgestrel IUD will be grouped by menstrual subphase at the time of insertion (early/late follicular and early/late luteal). Participants will have a baseline gynecologic exam, transvaginal ultrasound, and hormone profile, then scheduled ultrasound follow-ups at 0, 3, 6, and 12 months to document cyst occurrence, size, and structure. The study also records bleeding patterns, pain, and other adverse events without randomization or blinding. Statistical analysis will use chi-square or Fisher tests with effect sizes reported and standard p-value thresholds.
Why it matters
Potential benefit: If successful, the results could identify the best menstrual timing for LNG-IUD placement to reduce ovarian cyst risk and related symptoms.
How similar studies have gone: Other studies have reported ovarian cysts after levonorgestrel IUD use, but timing insertion by menstrual subphase has been little studied so this approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
SBÜ Gaziosmanpaşa Training and Research Hospital
Gaziosmanpaşa, Outside of the US, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: havva betül bacak, md — SBÜ Gaziosmanpaşa Training and Research Hospital
- Study coordinator: ecenur çelikoğlu, md
- Email: ecenucelikoglu14@gmail.com
- Phone: +905385492848
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.