Timing of LNG-IUD Insertion and Ovarian Cyst Formation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorGaziosmanpasa Research and Education Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Not listed
Trial groups
60 Participants
are grouped into 4 trial groupsSponsors and collaborators
Source ClinicalTrials.gov