RecruitingNCT07248553

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

Sponsor

Gaziosmanpasa Research and Education Hospital

Enrollment

60 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

Menstrual Cycle Ovarian Cysts Intrauterine Device (IUD)

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: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria7

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 Criteria8

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.