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Intra-operative Ultrasound Guided Laparoscopic Ovarian Cystectomy as a Method of Fertility Preservation (UGLOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05032846
Recruitment Status : Recruiting
First Posted : September 2, 2021
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
University College London Hospitals
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

Title:

Intra-operative ultrasound guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cysts.

Background:

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.

Aim:

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.

Eligibility

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.

Design:

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).

Duration:

3 years


Condition or disease Intervention/treatment Phase
Benign Ovarian Cyst Procedure: Ultrasound guided laparoscopic ovarian cystectomy Other: Laparoscopic Ovarian Cystectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-blinded randomised clinical trial
Masking: None (Open Label)
Masking Description: Non-blinded study
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cysts

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Anti-Mullerian Hormone (AMH) (pmol/L) [ Time Frame: 3 years ]
    Post operative AMH level will be measured at 3 and 6 months post surgery.

  2. Antral Follicle Count (AFC) (n) [ Time Frame: 3 years ]
    Post operative AFC will be measured at 3 and 6 months post surgery.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Duration of surgery (minutes) [ Time Frame: 3 years ]
    The duration of surgery will be measured in the control and experimental group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Joseph Yazbek, MD 02076366765 joseph.yazbek@nhs.net
Contact: Lorraine S Kasaven, MBChB 02076366765 L.kasaven@nhs.net

Locations
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United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W14 OHS
Contact: Lorraine Kasaven, MRCOG    07775679821    l.kasaven@nhs.net   
Sub-Investigator: Lorraine Kasaven, MRCOG         
Principal Investigator: Joseph Yazbek, MD         
Sponsors and Collaborators
Imperial College London
University College London Hospitals
Investigators
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Principal Investigator: Joseph Yazbek, MD Imperial College London Healthcare Trust
  Study Documents (Full-Text)

Documents provided by Imperial College London:
Statistical Analysis Plan  [PDF] August 9, 2021
Informed Consent Form  [PDF] June 15, 2021

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT05032846    
Other Study ID Numbers: IRAS 290747
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It will not be necessary to share individual participant data (IPD) with other researchers outside of the immediate research team. The only members with access to the information will be the PI (Joseph Yazbek) and the tudy Co-ordinator (Lorraine Kasaven).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Intraoperative ultrasound
Fertility Preservation
Benign Ovarian Cyst
Anti-Mullerian Hormone
Additional relevant MeSH terms:
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Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases