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Recruiting Observational

Timing of LNG-IUD Insertion and Ovarian Cyst Formation

NCT07248553 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-06-01
Last updated
2025-11-25

Condition(s) studied

Ovarian CystsMenstrual CycleIntrauterine Device (IUD)

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of Ovarian Cyst Formation — Baseline, 3 months, 6 months, and 12 months post-insertion
    Occurrence of new ovarian cysts detected by transvaginal or transabdominal ultrasound after LNG-IUD insertion.

Trial sites (1)

FacilityCityRegionStatus
SBÜ Gaziosmanpaşa Training and Research Hospital Gaziosmanpaşa Outside of the US Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07248553 on ClinicalTrials.gov ↗ ← All trials in Turkey