Hysteroscopic metroplasty of a uterine septum for primary infertility

In some women the uterus (womb) is divided into 2 halves by a thin wall of tissue, called a septum. This is an abnormality that some women are born with.  It may affect fertility and increase the risk of miscarriage. In hysteroscopic metroplasty a thin flexible tube with a camera on the end (a hysteroscope) is inserted into the vagina, through the cervix and into the womb. Instruments are passed through the hysteroscope into the womb and the septum is removed.

The National Institute for Health and Care Excellence (NICE) is examining hysteroscopic metroplasty of a uterine septum for primary infertility and will publish guidance on its safety and efficacy to the NHS. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of specialist advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about hysteroscopic metroplasty of a uterine septum for primary infertility.

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 provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

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

The process that NICE 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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website.

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 2 October 2014

Target date for publication of guidance: 17 December 2014

 

 

 

 

 

1                      Provisional recommendations

1.1              Current evidence on the safety of hysteroscopic metroplasty of a uterine septum for primary infertility includes some serious but rare complications. Current evidence on efficacy is inadequate in quantity and quality. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2              Clinicians wishing to undertake hysteroscopic metroplasty of a uterine septum for primary infertility should take the following actions.

·      Inform the clinical governance leads in their NHS trusts.

·      Ensure that women understand the uncertainty about the procedure’s efficacy and provide them with clear written information. In addition, the use of NICE’s information for the public [[URL to be added at publication]] is recommended.

·      Audit [URL to audit tool to be added at publication] and review clinical outcomes of all women having hysteroscopic metroplasty of a uterine septum for primary infertility.

1.3                  Patient selection and treatment should be done by a multidisciplinary team including specialists in reproductive medicine, uterine imaging and hysteroscopic surgery.

1.4                  Clinicians undertaking hysteroscopic metroplasty of a uterine septum for primary infertility should be trained in hysteroscopic surgery in accordance with the Royal College of Obstetricians and Gynaecologists training module.

1.5                  Further research should include clear documentation of patient selection and of all complications. Outcomes should include pregnancy rates, live birth rates and instances of pre-term delivery. Comparative studies would be helpful. NICE may review the procedure on publication of further evidence.

 

 

 

 

2                      Indications and current treatments

2.1                  A uterine septum is a congenital anomaly (present from birth). The septum is a muscular or fibrous wall that divides the inside of the uterus, creating 2 cavities (a septate uterus). The septum may be complete or incomplete. It is more common in women with primary infertility and in women who have had repeated miscarriages, and may therefore be one cause of these problems.

2.2                  Surgical removal of the septum (metroplasty) is usually considered for women who have a septate uterus in association with repeated adverse reproductive outcomes, including a history of recurrent miscarriage (usually defined as 3 or more miscarriages in a row) and preterm delivery. Metroplasty is also used to manage primary infertility but the causal relationship between this problem and the presence of a uterine septum is less certain.

2.3                  Metroplasty was traditionally done by a transabdominal approach. A hysteroscopic approach aims to reduce morbidity and shorten the recovery period. Unlike transabdominal metroplasty, caesarean section is not mandatory for patients who conceive after hysteroscopic metroplasty.

3                      The procedure

3.1                  Hysteroscopic metroplasty of a uterine septum for primary infertility aims to create a normal uterine cavity by removing the uterine septum, which may consequently increase fertility.

3.2                  Hysteroscopic metroplasty is usually done with the patient under general or spinal anaesthesia. After cervical dilation, a hysteroscope is inserted into the uterus through the cervix. The uterine cavity is distended using an appropriate fluid; fluid control must be carefully monitored to avoid fluid overload. The septum is excised, most commonly using microscissors, electrosurgery or laser. The procedure may be done using ultrasound or laparoscopic guidance.

 

 

 

4                      Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1                  A review of 2528 women (37 studies) with a septate uterus and a history of recurrent miscarriage, infertility, spontaneous abortion or preterm delivery that included a meta-analysis of 2074 women (29 studies) reported a live birth rate of 50% after hysteroscopic metroplasty (95% confidence interval [CI] 43 to 57; 19 studies, n=1525) (follow-up period not reported).

4.2                  A case series of 246 women with a septate uterus and a history of recurrent miscarriage or infertility reported that 57% (61/108) of women with unexplained fertility became pregnant after hysteroscopic metroplasty, with a live birth rate of 75% (44/71) of pregnancies; there were 12 ongoing pregnancies at the close of the study. The preterm delivery rate was 10% (7/71). A case series of 263 women with a septate uterus and a history of primary or secondary infertility or a history of recurrent miscarriage reported that 38% (57/149) of women with primary infertility achieved pregnancy after hysteroscopic metroplasty, with a term delivery rate of 88% (50/57). A case series of 181 women with a septate uterus and a history of unexplained infertility or more than 1 miscarriage reported that 44% (43/98) of women with unexplained infertility became pregnant after hysteroscopic metroplasty; there were 51 pregnancies, 36 of which were spontaneous and the live birth rate was 80% (41/51). Of the 36 spontaneous pregnancies, 22% (8/36) had a preterm delivery.

4.3                  The specialist advisers listed key efficacy outcomes as a normal-sized uterine cavity, improved pregnancy outcome, improved fertility, malpresentation rate, and reduction in difficulty in labour and delivery.

 

 

 

 

5                      Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. Evidence on women with both a history of recurrent miscarriage and primary infertility has been includedbecause the procedure is the same for both and therefore the safety events are relevant to both conditions. For more detailed information on the evidence, see the interventional procedure overview.

5.1                  Uterine perforation after hysteroscopic metroplasty was reported in 1% (17/2167) of women in a review of 2528 women (37 studies) and in 1% (8/923) of women in a case series of 973 women. Uterine perforation was reported in 1% (2/170) of women in a case series of 170 women; these were managed by laparoscopic bipolar coagulation and both patients were discharged the same day. One of these women subsequently had a pregnancy that carried to term, with delivery by caesarean section.

5.2                  Uterine rupture during pregnancy or delivery was identified in 18 confirmed reports in the review of 2528 women; in 10 of the 18 cases, uterine perforation had occurred at the time of the hysteroscopic metroplasty.

5.3                  Intraoperative bleeding with ‘interruption of the procedure’ was reported in 1 woman in the case series of 973 women. Excessive bleeding was reported in 1% (2/170) of women in the case series of 170 women; this was managed by an intrauterine balloon catheter kept in situ for 4 hours.

5.4                  Cervical laceration (not further described) was reported in less than 1% (2/2167) of women in the review of 2528 women. Difficult dilatation leading to cervical injury (not further described) was reported in 1 woman in the case series of 170 women.

5.5                  Pulmonary oedema was reported in 1 woman each in the review of 2528 women and in the case series of 973 women (no further details reported).

5.6                  Uterine synechiae after hysteroscopic metroplasty were reported in 2% (4/181) of women in a case series of 181 women (these synechiae were all treated surgically) and in 1 woman (1/2167) in the review of 2528 women (treatment not reported). Mild adhesions were reported in 7% (11/170) of women in the case series of 170 women (diagnosed by hysteroscopy). These adhesions were all treated by hysteroscopic adhesiolysis; 7 of the women subsequently became pregnant and had term deliveries.

5.7                  Interstitial ectopic pregnancy after hysteroscopic metroplasty was reported in 1 woman in a case report. A laparotomy was done to resect a wedge of myometrium that was completely enclosing the gestational sac. A hysteroscopy was done 4 months later and showed only a fine linear scar at the fundus, and the uterine cavity was otherwise normal.

5.8                  The specialist advisers listed the following theoretical adverse events: incomplete resection of the septum, infection, placenta accreta and percreta, a negative effect on fertility through damage to the endometrium, and detrimental effect on uterine and endometrial blood flow.

 

 

 

 

6                      Further information

6.1                  This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.

6.2                  For related NICE guidance, see the NICE website.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
August, 2014