NCT07248553Recruiting
Timing of LNG-IUD Insertion and Ovarian Cyst Formation
The Effect of Levonorgestrel-Containing Intrauterine Device (LNG-IUD) Insertion Timing on Ovarian Cyst Development According to the Early and Late Follicular and Luteal Phases
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- NCT number
- NCT07248553
What you commit to
- Study type: Observational
- Planned participants: 60
- From 1 Jun 2025 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients using hormone therapy
Other illness
- 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)
Other
- Pregnancy history or current pregnancy
- Patients with adnexal masses
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SBÜ Gaziosmanpaşa Training and Research Hospital Coordinator of this site? Confirm its status | Gaziosmanpaşa | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.