Timing of LNG-IUD Insertion and Ovarian Cyst Formation (LNG-IUD TIMING)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cysts; Menstrual Cycle; Intrauterine Device (IUD)

Detailed Description

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).

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: yağmur acıyiyen, md; Phone Number: +905425669593; Email: yagmuraciyiyen95@gmail.com
• Study Contact Backup: Name: ecenur çelikoğlu, md; Phone Number: +905385492848; Email: ecenucelikoglu14@gmail.com

Study Locations

• Turkey (Türkiye)
  • Outside of the US
    • Gaziosmanpaşa, Outside of the US, Turkey (Türkiye), 33400
      • Recruiting
      • SBÜ Gaziosmanpaşa Training and Research Hospital
      • Contact: ecenur çelikoğlu, md; Phone Number: +905385492848; Email: ecenucelikoglu14@gmail.com
      • Contact: havva betül bacak, md; Phone Number: +905333610088; Email: hbbacak90@gmail.com
      • Principal Investigator: havva betül bacak, md
      • Sub-Investigator: yağmur acıyiyen, md
      • Sub-Investigator: ecenur çelikoğlu, md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Investigators: Principal Investigator: havva betül bacak, md, SBÜ Gaziosmanpaşa Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Ovarian Cyst; Levonorgestrel-Releasing Intrauterine Device; Menstrual Cycle Phase
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Cysts; Ovarian Cysts
• Other Study ID Numbers: GOPEAH-LNGIUD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No