Comparing two surgical methods for treating endometriomas in women planning future pregnancies
Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans
NA · Institute for the Care of Mother and Child, Prague, Czech Republic · NCT05801523
This study is testing whether a new method using alcohol or traditional surgery is better for treating endometriomas in women who want to have children in the future.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Institute for the Care of Mother and Child, Prague, Czech Republic (other) |
| Locations | 1 site (Prague) |
| Trial ID | NCT05801523 on ClinicalTrials.gov |
What this trial studies
This prospective randomized study aims to compare the effectiveness of laparoscopic sclerotherapy using 96% ethanol versus cystectomy in patients with endometriomas who wish to preserve their reproductive options. A total of 160 participants will be enrolled, with 80 assigned to each treatment group. The study will assess various outcomes, including changes in Anti-Müllerian Hormone (AMH) levels, recurrence of endometriomas, complications, pregnancy rates, and success rates of assisted reproduction methods. Participants will undergo surgery, followed by follow-up visits at 3, 6, and 12 months to monitor their progress and outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women with unilateral or bilateral endometriomas measuring 30mm or more who have unfinished reproductive plans.
Not a fit: Patients with recurrent endometriomas, signs of ovarian malignancy, or inflammatory pelvic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective surgical approach for women with endometriomas who wish to conceive in the future.
How similar studies have performed: Other studies have explored similar surgical approaches for endometriomas, but this specific comparison of sclerotherapy versus cystectomy in the context of future pregnancy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * IOTA benign endometrioma * bilateral or unilateral endometrioma measuring 30 or more milimeters * patients with unfinished reproductive plans Exclusion Criteria: * bilateral recurrence of endometrioma * recurrent endometrioma if the other ovary is not present or patient had cystectomy on the other ovary * suspision for ovarian malignancy * signs of inflammatory pelvic disease * disagreement with participation in the study
Where this trial is running
Prague
- Institute for mother and child care — Prague, Czechia (RECRUITING)
Study contacts
- Principal investigator: Katarína Ivánková, MUDr. — Institute for the Care of Mother and Child, Prague, Czech Republic
- Study coordinator: Katarína Ivánková
- Email: katarina.ivankova@upmd.eu
- Phone: +420 296511200
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: Endometrioma, Endometriosis, laparoscopic, sclerotherapy, endometrioma