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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Turkey
SBÜ Gaziosmanpaşa Training and Research Hospital
RECRUITING
Gaziosmanpaşa
Contact Information
Primary
ecenur çelikoğlu, md
ecenucelikoglu14@gmail.com
+905385492848
Backup
yağmur acıyiyen, md
yagmuraciyiyen95@gmail.com
+905425669593
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 60
Treatments
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).
Sponsors
Leads: Gaziosmanpasa Research and Education Hospital

This content was sourced from clinicaltrials.gov