NCT07248553 Timing of LNG-IUD Insertion and Ovarian Cyst Formation
| NCT ID | NCT07248553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gaziosmanpasa Research and Education Hospital |
| Condition | Ovarian Cysts |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-06-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 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.
Contact & Investigator
havva betül bacak, md
PRINCIPAL INVESTIGATOR
SBÜ Gaziosmanpaşa Training and Research Hospital
Frequently Asked Questions
Who can join the NCT07248553 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Ovarian Cysts. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07248553 currently recruiting?
Yes, NCT07248553 is actively recruiting participants. Contact the research team at ecenucelikoglu14@gmail.com for enrollment information.
Where is the NCT07248553 trial being conducted?
This trial is being conducted at Gaziosmanpaşa, Turkey (Türkiye).
Who is sponsoring the NCT07248553 clinical trial?
NCT07248553 is sponsored by Gaziosmanpasa Research and Education Hospital. The principal investigator is havva betül bacak, md at SBÜ Gaziosmanpaşa Training and Research Hospital. The trial plans to enroll 60 participants.