Clinical trial · Observational
Timing of LNG-IUD Insertion and Ovarian Cyst Formation
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this prospective observational study, the effect of timing of insertion (early/late follicular; early/late luteal) on ovarian cyst development in women receiving an LNG-IUD will be assessed ultrasonographically at months 0, 3, 6, and 12. Secondary outcomes include cyst size/structure, bleeding pattern, pain, and other adverse events.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrauterine Device (IUD) | — | UNRESOLVED | — |
| Menstrual Cycle | — | UNRESOLVED | — |
| Ovarian Cysts | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Early Follicular Phase
- description
- LNG-IUD inserted during early follicular phase (days 1-5).
- label
- Late Follicular Phase
- description
- LNG-IUD inserted during late follicular phase (days 6-13).
- label
- Early Luteal Phase
- description
- LNG-IUD inserted during early luteal phase (days 14-21).
- label
- Late Luteal Phase
- description
- LNG-IUD inserted during late luteal phase (days 22-28).
Primary outcomes (1)
- measure
- Incidence of Ovarian Cyst Formation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available