An observational study in Ovarian Cysts, Menstrual Cycle and Intrauterine Device (IUD), sponsored by Gaziosmanpasa Research and Education Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Gaziosmanpasa Research and Education Hospital · Observational
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.
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).
80 studies on the registry are indexed under Ovarian Cysts; 16 are open to participants now.
This study's planned enrollment of 60 is below the median of 200 across 27 observational studies indexed under Ovarian Cysts.
Browse Ovarian Cysts studies →Gaziosmanpasa Research and Education Hospital is the lead sponsor of 126 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LNG-IUD inserted during early follicular phase (days 1-5).
LNG-IUD inserted during late follicular phase (days 6-13).
LNG-IUD inserted during early luteal phase (days 14-21).
LNG-IUD inserted during late luteal phase (days 22-28).
Incidence of Ovarian Cyst Formation
Occurrence of new ovarian cysts detected by transvaginal or transabdominal ultrasound after LNG-IUD insertion.
Time frame: Baseline, 3 months, 6 months, and 12 months post-insertion
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jun 2026, 12 months after the start.
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