The National Institute for Clinical Excellence is examining fallopian tube recanalisation by guidewire and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about fallopian tube recanalisation by guidewire.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the preliminary recommendation
• the identification of factual inaccuracies
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows:

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance, which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 27 April 2004

Target date for publication of guidance: July 2004

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Fallopian tube recanalisation by guidewire is safe enough for routine use provided that the normal arrangements are in place for consent, audit and clinical governance. However, its efficacy in improving the chance of pregnancy is impossible to gauge from available research.

Clinicians wishing to undertake fallopian tube recanalisation by guidewire should take the following action.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the procedure's efficacy and provide them with clear written information. Use of the Institute's Information for the Public is recommended.
• Audit and review clinical outcomes of all patients having fallopian tube recanalisation by guidewire.

Publication of efficacy outcomes will be useful in reducing the current uncertainty. The Institute may review the procedure upon publication of further evidence.

Fallopian tube recanalisation by guidewire is a treatment for infertility caused by blocked fallopian tubes, especially if the blockage is close to the entrance to the uterus (proximal).

Alternative radiological methods of clearing tubal obstruction include balloon tuboplasty, which involves inflating a small balloon within the fallopian tube. Tubal obstruction may also be treated surgically.

Fallopian tube recanalisation by guidewire is carried out during the same treatment session as diagnostic salpingography and involves inserting a fine tube (catheter) past the obstruction in a fallopian tube. This, or the subsequent injection of radio-opaque dye, may clear the obstruction. If these strategies fail, a guidewire may be passed up into the fallopian tube through the catheter, and manipulated to clear the obstruction.

No controlled studies were identified. Successful recanalisation was reported in 77% (321/417) of tubes in one study and in 75% (176/234) of patients in another. Another study reported that 22% (39/176) of patients who had undergone guidewire recanalisation had live births. Spontaneous pregnancy within 12 months of the procedure was reported in 10% (30/302) of recanalised patients in another study. For more details, refer to the sources of evidence (see Appendix).

One Specialist Advisor noted that degree of efficacy may depend on patient selection.

In the studies identified, the rate of tubal perforation ranged from 1% (4/417) to 11% (4/38), and the rate of tubal pregnancy from 0.4% (1/234) to 8% (3/38). Other reported complications were sepsis in 0.9% (2/234) of patients, and pain requiring medication in 3% (7/234 and 4/150) of patients. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors listed the main potential complications as fallopian tube perforation, intra-abdominal bleeding, and infection.

There is a distinction between efficacy in terms of opening the fallopian tubes and in terms of achieving pregnancy.

The procedure is often used as an adjunct to other fertility treatments.

There is a potential risk of tubal perforation, which may then reduce the chance of pregnancy.

Although the evidence showed an increased risk of tubal pregnancy it was noted that there was generally a greater risk of tubal pregnancy in patients with tubal disease, even without this procedure.

The Institute has issued a clinical guideline Fertility: Assessment and treatment for people with fertility problems, available from www.nice.org.uk

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

• Interventional procedure overview of fallopian tube recanalisation by guidewire, May 2003

Available from: www.nice.org.uk/ip097overview