Intra-operative Ultrasound Guided Laparoscopic Ovarian Cystectomy as a Method of Fertility Preservation (UGLOC)
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|ClinicalTrials.gov Identifier: NCT05032846|
Recruitment Status : Recruiting
First Posted : September 2, 2021
Last Update Posted : March 31, 2022
Intra-operative ultrasound guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cysts.
Approximately 10% of women in the United Kingdom (UK) will undergo surgery for the presence of an ovarian mass during their lifetime. Ovarian surgery, however, is not without risks and can potentially harm healthy ovarian tissue surrounding the cyst, resulting in reduced reproductive potential (the ability of the ovary to produce eggs for fertilisation). Surgical methods to preserve healthy ovarian tissue and improve the chances of successful pregnancy post-operatively are known as Fertility Preserving Surgery (FPS). Evidence suggests that a novel approach of FPS involving the removal of an ovarian cyst performed under ultrasound guidance improves the differentiation between the healthy ovarian tissue and the ovarian cyst. As such, the surgeon can remove the cyst alone, whilst limiting disruption to the healthy surrounding ovarian tissue.
The purpose of this study is to assess if surgical removal of an ovarian cyst performed under ultrasound guidance improves the reproductive potential of the ovaries, when compared to surgery performed without ultrasound guidance.
All patients of reproductive age (18-45 years old) with ultrasound features suggestive of a benign ovarian cyst requiring surgical treatment (removal of the cyst). Patients diagnosed with benign ovarian cysts, deemed to be non -harmful to the patient if left untreated, of the following classifications can be included in the study: dermoid, simple cyst, serous cystadenoma, mucinous cystadenoma or endometrioma.
A multicentre randomised controlled trial. Women across Imperial College London Healthcare and University College London Trusts will be allocated to a surgical treatment group at random: 1) laparoscopic ovarian cystectomy performed without ultrasound guidance (control group) or 2) ultrasound guided laparoscopic ovarian cystectomy performed with ultrasound guidance (fertility preservation surgery: intervention group).
|Condition or disease||Intervention/treatment||Phase|
|Benign Ovarian Cyst||Procedure: Ultrasound guided laparoscopic ovarian cystectomy Other: Laparoscopic Ovarian Cystectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Non-blinded randomised clinical trial|
|Masking:||None (Open Label)|
|Masking Description:||Non-blinded study|
|Official Title:||Intra-operative Ultrasound Guided Laparoscopic Ovarian Cystectomy (UGLOC) as a Method of Fertility Preservation in the Management of Benign Ovarian Cysts: Randomised Controlled Trial|
|Actual Study Start Date :||October 1, 2021|
|Estimated Primary Completion Date :||October 1, 2024|
|Estimated Study Completion Date :||October 1, 2025|
Experimental: Ultrasound Guided Laparoscopic Ovarian Cystectomy
During surgical resection of the ovarian cyst, a clinician with experience of ultrasound and laparoscopy will perform an ultrasound scan during surgery to resect cyst tissue only and preserve healthy ovarian tissue.
Procedure: Ultrasound guided laparoscopic ovarian cystectomy
Laparoscopic ovarian cystectomy to be performed under intra-operative ultrasound guidance.
Active Comparator: Laparoscopic Ovarian Cystectomy
A laparoscopic ovarian cystectomy will be performed without ultrasound guidance. This is currently standard clinical practice.
Other: Laparoscopic Ovarian Cystectomy
Laparoscopic Ovarian Cystectomy will be performed as standard clinical practice.
- Anti-Mullerian Hormone (AMH) (pmol/L) [ Time Frame: 3 years ]Post operative AMH level will be measured at 3 and 6 months post surgery.
- Antral Follicle Count (AFC) (n) [ Time Frame: 3 years ]Post operative AFC will be measured at 3 and 6 months post surgery.
- Length of hospital stay (days) [ Time Frame: 3 years ]Surgical outcomes will be determined such as the length of hospital stay measured in days in the control and experimental group.
- Presence of intra-operative cyst rupture (Yes/No) [ Time Frame: 3 years ]During the procedure, it will be determined whether or not there has been a cyst rupture, whereby cyst contents have dispersed into the abdominal cavity in the control and experimental group.
- Duration of surgery (minutes) [ Time Frame: 3 years ]The duration of surgery will be measured in the control and experimental group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05032846
|Contact: Joseph Yazbek, MDfirstname.lastname@example.org|
|Contact: Lorraine S Kasaven, MBChB||02076366765||L.email@example.com|
|Imperial College Healthcare NHS Trust||Recruiting|
|London, United Kingdom, W14 OHS|
|Contact: Lorraine Kasaven, MRCOG 07775679821 firstname.lastname@example.org|
|Sub-Investigator: Lorraine Kasaven, MRCOG|
|Principal Investigator: Joseph Yazbek, MD|
|Principal Investigator:||Joseph Yazbek, MD||Imperial College London Healthcare Trust|