Evaluating the effects of dydrogesterone on ovarian endometriosis
Efficacy and Safety of Dydrogesterone After Operation of Ovarian Endometrial Cysts: a Multicenter, Observational Clinical Study
Guangdong Women and Children Hospital · NCT05976529
This study is testing if dydrogesterone can help women with ovarian endometriosis feel better and improve their fertility after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Guangdong Women and Children Hospital (other) |
| Locations | 1 site (Guanzhou, Guangdong) |
| Trial ID | NCT05976529 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of dydrogesterone in managing ovarian endometriosis cysts following surgical excision. It focuses on patients who have undergone laparoscopic surgery and have been diagnosed with ovarian endometriosis cysts larger than 4 cm. The study will monitor the long-term therapeutic effects of dydrogesterone on symptoms such as dysmenorrhea and chronic pelvic pain, as well as its impact on fertility. The research is particularly relevant given the increasing incidence of endometriosis among women in China.
Who should consider this trial
Good fit: Ideal candidates for this study are women who have undergone surgery for ovarian endometriosis cysts and are experiencing infertility or have not responded to previous medications.
Not a fit: Patients with ovulation disorders, severe liver or kidney issues, or those who have taken hormone medications recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new long-term treatment option for women suffering from ovarian endometriosis, potentially improving their quality of life and fertility outcomes.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in using hormonal treatments for managing endometriosis symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guanzhou, Guangdong
- Guangdong Women and Children Hospital — Guanzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Chen Yuan, Master — Guangdong Women and Children Hosptial
- Study coordinator: Li Li, M.D.
- Email: lili-1406@163.com
- Phone: +86 13631446859
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometriosis, Endometriosis Ovary, endometriosis, dydrogesterone, therapeutic effect evaluation, safety, dienogest