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
This trial does not accept healthy volunteersQualifiers
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 population
The study population will consist of women aged 18 to 45 years who are clinically indicated for levonorgestrel-releasing intrauterine device (LNG-IUD) insertion for contraception or therapeutic purposes. Participants will be recruited from the outpatient gynecology clinic of SBÜ Gaziosmanpaşa Training and Research Hospital. All participants will have regular menstrual cycles and no contraindications to LNG-IUD use. They will be assigned to one of four observational cohorts (early follicular, late follicular, early luteal, or late luteal phase) according to the menstrual phase at the time of insertion.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 4 trial groupsGroup A: Early Follicular Phase
Group B: Late Follicular Phase
Group C: Early Luteal Phase
Group D: Late Luteal Phase
Trial outcomes
Primary outcomes
1
Incidence of Ovarian Cyst Formation
Occurrence of new ovarian cysts detected by transvaginal or transabdominal ultrasound after LNG-IUD insertion.
Time frame
Baseline, 3 months, 6 months, and 12 months post-insertionSponsors and contacts
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Source ClinicalTrials.gov