Using ultrasound to guide laparoscopic surgery for ovarian cysts to help preserve fertility
Intra-operative Ultrasound Guided Laparoscopic Ovarian Cystectomy (UGLOC) as a Method of Fertility Preservation in the Management of Benign Ovarian Cysts: Randomised Controlled Trial
This study tests if using ultrasound during surgery for ovarian cysts can help women keep their fertility by making it easier to avoid damaging healthy tissue.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05032846 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of intra-operative ultrasound guidance during laparoscopic ovarian cystectomy to enhance fertility preservation in women with benign ovarian cysts. By providing real-time imaging, the technique aims to improve the differentiation between healthy ovarian tissue and cysts, thereby minimizing damage to surrounding tissue during surgery. The study includes patients of reproductive age diagnosed with specific types of benign ovarian cysts, and it evaluates the effectiveness of this novel approach in reducing complications and improving surgical outcomes. The ultimate goal is to enhance reproductive potential post-surgery.
Who should consider this trial
Good fit: Ideal candidates are women of reproductive age with a diagnosis of benign ovarian cysts requiring surgical management.
Not a fit: Patients with malignant ovarian cysts or those who do not require surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve fertility preservation for women undergoing surgery for benign ovarian cysts.
How similar studies have performed: Previous studies have shown promising results with similar ultrasound-guided surgical techniques, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients of reproductive age with a diagnosis of a benign ovarian cyst requiring surgical management. This includes cysts defined as dermoid, teratoma, simple cyst, functional, serous cystadenoma or mucinous cystadenoma from the initial diagnostic ultrasound. A strict criterion for the US diagnostic features will include the following: * Cyst size ≥3cm; ≤10cm * The International Ovarian Tumour Analysis for benign features (IOTA B) only: * Unilocular * Solid components: largest diameter ≤7mm * Acoustic shadows * No blood flow * Smooth multilocular cyst: largest diameter ≤10cm Specifically: * Pregnant patients can be included but will be analysed separately * For patients selected for surgery, delay of surgery is not an exclusion criterion for this study, but for selected objectives we will use only those patients in whom surgery was performed within 180 days after the ultrasound examination * With regards to age, patients can be selected only if 18-50 years old. * Patients whom only underwent transabdominal scanning can be included in the study, but will be analysed separately Exclusion Criteria: * Cysts that are deemed to be clearly physiological and less than \<3 cm in maximum diameter are not eligible for inclusion * Cysts ≥11cm in maximum diameter * Non-adnexal masses e.g. peritoneal inclusion cysts (where diagnosis is certain). * Any cyst with features of malignancy * The denial or withdrawal of written informed consent * Women of post- menopausal or peri-menopausal status
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Joseph Yazbek, MD — Imperial College London Healthcare Trust
- Study coordinator: Joseph Yazbek, MD
- Email: joseph.yazbek@nhs.net
- Phone: 02076366765
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.