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NCT Number: NCT07248553

Timing of LNG-IUD Insertion and Ovarian Cyst Formation

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

SBÜ Gaziosmanpaşa Training and Research Hospital

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

Location status: Recruiting

Location contact

ecenur çelikoğlu, md

CONTACT

[email protected]

+905385492848

ecenur çelikoğlu, md

SUB_INVESTIGATOR

havva betül bacak, md

CONTACT

[email protected]

+905333610088

havva betül bacak, md

PRINCIPAL_INVESTIGATOR

yağmur acıyiyen, md

SUB_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of Ovarian Cyst Formation

    Time frame: Baseline, 3 months, 6 months, and 12 months post-insertion

    Occurrence of new ovarian cysts detected by transvaginal or transabdominal ultrasound after LNG-IUD insertion.

Study contacts

Contact information is provided by the study sponsor or research team.

ecenur çelikoğlu, md

CONTACT

[email protected]

+905385492848

yağmur acıyiyen, md

CONTACT

[email protected]

+905425669593

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

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

Acronym: LNG-IUD TIMING

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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