Timing of levonorgestrel IUD placement and ovarian cysts
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
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Locations | 1 site (Gaziosmanpaşa, Outside of the US) |
| Trial ID | NCT07248553 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gaziosmanpaşa, Outside of the US
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.