A Multicenter, Observational Clinical Study of Dydrogesterone (NCT05976529) | Clinical Trial Compass
UnknownNot Applicable
A Multicenter, Observational Clinical Study of Dydrogesterone
China400 participantsStarted 2023-01-01
Plain-language summary
The objective of this study was to investigate the efficacy and safety of dydrogesterone in the long-term management of ovarian endometriosis cyst after surgery.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who had undergone laparoscopic ovarian cyst excision and were confirmed by pathological diagnosis as ovarian endometriosis cyst (pathology was completed in each central hospital).
* Ovarian cyst \>4cm.
* Concomitant infertility.
* Patients who fail to respond to medication.
* American Society of Reproductive Medicine(ASRM) stages were II-IV.
* No relevant therapeutic drugs, such as dydrogesterone, dienogest, GnRHa, etc., were used 3 months before treatment.
* No combined endocrine diseases.
Exclusion Criteria:
* Ovulation disorders, immune defects and genital development abnormalities caused by infertility.
* Patients who are allergic to the drugs used in this study.
* Patients with severe hepatorenal insufficiency or malignant tumor.
* Those who took hormone medication within 3 months before the study date.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual analogue pain score(VAS)
Timeframe: before drug treatment and 3 months after drug treatment
2
Endometriosis fertility index(EFI)
Timeframe: before drug treatment and 3 months after drug treatment
3
The Cox Menstrual Symptom Scale(CMSS)
Timeframe: before drug treatment and 3 months after drug treatment