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20/73 Surgery for endometrioma in women undergoing IVF

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research question

Does surgical removal of endometrioma prior to commencement of IVF improve live birth rates?

  1. Intervention: Usual care plus surgical removal (excision or ablation) of endometrioma, prior to commencement of IVF (applicants to define and justify).
  2. Patient group: Women undergoing IVF treatment with at least one endometrioma (applicants to define and justify).
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: Secondary care. Applicants to justify where in the patient pathway randomisation will occur.
  4. Control: Usual care not including surgical removal of endometrioma and proceeding straight to IVF (applicants to define and justify).
  5. Study design: A randomised controlled trial with a robust internal pilot phase to test the ability to recruit and randomise. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
  6. Important outcomes: Live birth rate; healthy baby rate (defined as term singleton live birth with appropriate weight for gestation); quality of life; cost to the health service of treatment, pregnancy and delivery care.
    Other outcomes: Ovarian reserve; number of eggs collected; miscarriage rate; ectopic pregnancy; very preterm/preterm delivery; adverse events.
  7. Minimum duration of follow-up: Applicants to define and justify.

Rationale

Endometriosis is an inflammatory condition characterised by the presence of tissue resembling endometrium in sites other than the uterine cavity. Endometriosis is frequently reported as the underlying aetiology of infertility requiring the use of assisted reproductive technology, including in vitro fertilization (IVF).

Ovarian endometrioma (often also called ovarian or chocolate cysts) are a form of pelvic endometriosis, presenting as a chocolate like fluid-containing cyst, located inside the ovary. How best to manage endometrioma in women having IVF remains uncertain with mixed evidence on which to base clinical decisions.

There is some evidence which shows there is little difference in IVF pregnancy and live birth rates for women with endometrioma who have surgery and in those who don’t have the surgery, the evidence base is weak. There is also some evidence which shows that surgery can have a negative impact on future ovarian reserve which has an impact on potential future fertility.

An important conversation with the patient is required to explain and discuss all the potential positive and negative implications of treatment and non-treatment. Applicants will be required to demonstrate strong PPI involvement in their application. An adequately powered randomised trial is required to inform the discussion with patients and to provide the evidence to inform practice.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 2nd December 2020. Applications will be considered by the HTA Funding Committee at its meeting in January 2021.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2021.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared. 

Should you have any queries please contact us

Email:

htacommissioning@nihr.ac.uk