Effect of Levonorgestrel-Containing Intrauterine Device Insertion Timing on Ovarian Cyst Development During Menstrual Cycle Phases

What this Trial Is About

Researchers are evaluating how the timing of inserting a levonorgestrel-containing intrauterine device (LNG-IUD) during different phases of the menstrual cycle affects the development of ovarian cysts. This prospective observational study focuses on women aged 18 to 45 who require LNG-IUD placement for various gynecological conditions such as abnormal uterine bleeding, endometriosis, or menorrhagia. The study is sponsored by Gaziosmanpasa Research and Education Hospital and aims to understand cyst formation related to insertion timing. The LNG-IUD will be inserted according to four specific menstrual cycle subphases: early follicular (days 1-5), late follicular (days 6-13), early luteal (days 14-21), and late luteal (days 22-28). Participants will undergo assessments including gynecological exams, ultrasounds, and hormone profiles before insertion. Follow-up ultrasounds will be conducted at 0, 3, 6, and 12 months post-insertion to monitor ovarian cyst incidence, size, structure, bleeding patterns, pain, and other side effects. The study has an observational design without randomization or blinding. Participants will be involved in multiple visits over a year with ultrasound examinations and hormone testing to track cyst development and other outcomes. Researchers will analyze these data using statistical methods to understand the relationship between insertion timing and cyst formation. The primary outcome is the incidence of ovarian cysts assessed at baseline and during follow-ups. Safety and adverse events will also be monitored throughout the study period.

Timing of LNG-IUD Insertion and Ovarian Cyst Formation