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Notice Summary

Title:
UK-Southampton: 19/127 Surgery for Endometrioma in Women Undergoing IVF
Document Ref:
GB003ZM313775
Document Type:
Contract Notice - Other
Published By:
National Institute for Health Research
Date Published:
05 November 2019
Deadline Date:
01 April 2020
Document Source:
Framework/DPS:
No
Alert Profile:
Labels:

Notice Abstract

19/127 Surgery for endometrioma in women undergoing IVF 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 source

Notice Details

CONTRACT NOTICE – NATIONAL

SERVICES

1 Authority Details

1.1

Authority Name and Address

National Institute for Health Research
N/A
Southampton UK
N/A N/A
N/A

1.2

Address from which documentation may be obtained

As in 1.1

1.3

Completed documents must be returned to:

As in 1.1

2 Contract Details

2.1

Title

19/127 Surgery for Endometrioma in Women Undergoing IVF

2.2

Description of the goods or services required

19/127 Surgery for endometrioma in women undergoing IVF

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.

2.3

Notice Coding and Classification

2.4

Total quantity or scope of tender

3 Conditions for Participation

3.1

Minimum standards and qualification required

4 Administrative Information

4.1

Type of Procedure

The procedure type is unknown.

4.2

Reference number attributed to the notice by the contracting authority

19/127

4.3

Time Limits

   01-04-2020  Time 13:00

4.5

Language or languages in which tenders or requests to participate can be drawn up

EN 

4.6

Tender Submission Postbox

5 Other Information

5.1

Additional Information

Please visit the following portal to view this notice:

https://www.nihr.ac.uk/documents/19127-surgery-for-endometrioma-in-women-undergoing-ivf/22726

Your application must be submitted on-line no later than 1pm on the 1st April 2020. Applications will be considered by the HTA Funding Committee at its meeting in May 2020.

(MT Ref:313775)

5.2

Additional Documentation

5.3

Publication date of this notice

 05-11-2019

Current Notes