Timing of LNG-IUD Insertion and Ovarian Cyst Formation

NCT07248553 | Recruiting

• 1 other identifier: GOPEAH-LNGIUD
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cysts; Menstrual Cycle; Intrauterine Device (IUD)

Keywords

Levonorgestrel-Releasing Intrauterine Device; Menstrual Cycle Phase; Ovarian Cyst

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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).

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

SBÜ Gaziosmanpaşa Training and Research Hospital

Gaziosmanpaşa, Outside of the US, 33400, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ovarian Cysts

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• havva betül bacak, md

  SBÜ Gaziosmanpaşa Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ecenur çelikoğlu, md

CONTACT

+905385492848; ecenucelikoglu14@gmail.com

yağmur acıyiyen, md

CONTACT

+905425669593; yagmuraciyiyen95@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Obstetrics and Gynecology

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)