Timing of LNG-IUD Insertion and Ovarian Cyst Formation

NCT ID: NCT07248553

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-06-01

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.

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).

Conditions

Ovarian Cysts; Menstrual Cycle; Intrauterine Device (IUD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early Follicular Phase

LNG-IUD inserted during early follicular phase (days 1-5).

No interventions assigned to this group

Late Follicular Phase

LNG-IUD inserted during late follicular phase (days 6-13).

No interventions assigned to this group

Early Luteal Phase

LNG-IUD inserted during early luteal phase (days 14-21).

No interventions assigned to this group

Late Luteal Phase

LNG-IUD inserted during late luteal phase (days 22-28).

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Havva Betül Bacak

Specialist in Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

havva betül bacak, md

Role: PRINCIPAL_INVESTIGATOR

SBÜ Gaziosmanpaşa Training and Research Hospital

Locations

SBÜ Gaziosmanpaşa Training and Research Hospital

Gaziosmanpaşa, Outside of the US, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

ecenur çelikoğlu, md

Role: CONTACT

ecenucelikoglu14@gmail.com

+905385492848

yağmur acıyiyen, md

Role: CONTACT

yagmuraciyiyen95@gmail.com

+905425669593

Facility Contacts

havva betül bacak, md

Role: primary

hbbacak90@gmail.com

+905333610088

ecenur çelikoğlu, md

Role: backup

ecenucelikoglu14@gmail.com

+905385492848

Other Identifiers

GOPEAH-LNGIUD

Identifier Type: -

Identifier Source: org_study_id