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

Gaziosmanpasa Research and Education Hospital

Status

Enrolling

Conditions

Ovarian Cysts

Intrauterine Device (IUD)

Menstrual Cycle

Study type

Observational

Funder types

Other

Identifiers

NCT07248553

GOPEAH-LNGIUD

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.