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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.
The menstrual cycle will be divided into four subphases, and the LNG-IUD will be placed according to these phases.Participants will be assessed initially with a gynecological examination, ultrasound, and hormone profile (FSH, LH, TSH, prolactin, estradiol, progesterone); they will be followed up with ultrasound at months 0, 3, 6, and 12.There is no randomization or blinding (observational design).Data analysis will be conducted using chi-square/Fisher, with Yates correction if necessary, and Cramer's V/phi as the effect size (p<0.05/0.01).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Follicular Phase | LNG-IUD inserted during early follicular phase (days 1-5). | ||
| Late Follicular Phase | LNG-IUD inserted during late follicular phase (days 6-13). | ||
| Early Luteal Phase | LNG-IUD inserted during early luteal phase (days 14-21). | ||
| Late Luteal Phase | LNG-IUD inserted during late luteal phase (days 22-28). |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Ovarian Cyst Formation | Occurrence of new ovarian cysts detected by transvaginal or transabdominal ultrasound after LNG-IUD insertion. | Baseline, 3 months, 6 months, and 12 months post-insertion |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ecenur çelikoğlu, md | Contact | +905385492848 | ecenucelikoglu14@gmail.com | |
| yağmur acıyiyen, md | Contact | +905425669593 | yagmuraciyiyen95@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| havva betül bacak, md | SBÜ Gaziosmanpaşa Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SBÜ Gaziosmanpaşa Training and Research Hospital | Recruiting | Gaziosmanpaşa | Outside of the US | 33400 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |