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

NCT05032846 | Unknown DMC

• 1 other identifier: IRAS 290747
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Benign Ovarian Cyst

Keywords

Intraoperative ultrasound; Fertility Preservation; Benign Ovarian Cyst; Anti-Mullerian Hormone

Outcome Measures

Primary Outcomes (2)

• Anti-Mullerian Hormone (AMH) (pmol/L)

  Post operative AMH level will be measured at 3 and 6 months post surgery.

  3 years

• Antral Follicle Count (AFC) (n)

  Post operative AFC will be measured at 3 and 6 months post surgery.

  3 years

Secondary Outcomes (3)

• Length of hospital stay (days)

  3 years

• Presence of intra-operative cyst rupture (Yes/No)

  3 years

• Duration of surgery (minutes)

  3 years

Study Arms (2)

Ultrasound Guided Laparoscopic Ovarian Cystectomy

EXPERIMENTAL

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

ACTIVE COMPARATOR

A laparoscopic ovarian cystectomy will be performed without ultrasound guidance. This is currently standard clinical practice.

Other: Laparoscopic Ovarian Cystectomy

Interventions

Ultrasound guided laparoscopic ovarian cystectomy PROCEDURE

Laparoscopic ovarian cystectomy to be performed under intra-operative ultrasound guidance.

Ultrasound Guided Laparoscopic Ovarian Cystectomy

Laparoscopic Ovarian Cystectomy OTHER

Laparoscopic Ovarian Cystectomy will be performed as standard clinical practice.

Laparoscopic Ovarian Cystectomy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• Cysts ≥11cm in maximum diameter
• Any cyst with features of malignancy
• The denial or withdrawal of written informed consent
• Women of post- menopausal or peri-menopausal status

Sponsors & Collaborators

• Imperial College London: lead
• University College London Hospitals: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W14 OHS, United Kingdom

RECRUITING

Related Publications (1)

• Kasaven LS, Jones BP, Ghaem-Maghami S, Verbakel JYJ, El-Bahrawy M, Saso S, Yazbek J. Study protocol for a randomised controlled trial on the use of intraoperative ultrasound-guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cysts. BMJ Open. 2022 Jul 14;12(7):e060409. doi: 10.1136/bmjopen-2021-060409.

  PMID: 35835531 DERIVED

Study Officials

• Joseph Yazbek, MD

  Imperial College London Healthcare Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Yazbek, MD

CONTACT

02076366765; joseph.yazbek@nhs.net

Lorraine S Kasaven, MBChB

CONTACT

02076366765; L.kasaven@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Non-blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-blinded randomised clinical trial

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: September 2, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)