Timing of LNG-IUD Insertion and Ovarian Cyst Formation

Recruiting now

Conditions studied: Ovarian Cysts, Menstrual Cycle, Intrauterine Device (IUD)

In brief

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.

Key facts

Study ID

NCT07248553

Run by

Gaziosmanpasa Research and Education Hospital

People needed

60

Starts

2025-06-01

Expected to finish

2026-06-01

Last updated by the study team

2025-11-25

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• SBÜ Gaziosmanpaşa Training and Research Hospital — Gaziosmanpaşa, Outside of the US, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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