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 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 became pregnant 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.

4.2

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).

4.3

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.