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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Incidence of Ovarian Cyst Formation
Timeframe: Baseline, 3 months, 6 months, and 12 months post-insertion
Trial details
NCT IDNCT07248553
SponsorGaziosmanpasa Research and Education Hospital