Abstract
BackgroundA septate uterus is a uterine anomaly that may affect reproductive outcome, and is associated with an increased risk for miscarriage, subfertility and preterm birth. Resection of the septum is subject of debate. There is no convincing evidence concerning its effectiveness and safety. This study aims to assess whether hysteroscopic septum resection improves reproductive outcome in women with a septate uterus.Methods/designA multi-centre randomised controlled trial comparing hysteroscopic septum resection and expectant management in women with recurrent miscarriage or subfertility and diagnosed with a septate uterus. The primary outcome is live birth, defined as the birth of a living foetus beyond 24 weeks of gestational age. Secondary outcomes are ongoing pregnancy, clinical pregnancy, miscarriage and complications following hysteroscopic septum resection. The analysis will be performed according to the intention to treat principle. Kaplan-Meier curves will be constructed, estimating the cumulative probability of conception leading to live birth rate over time. Based on retrospective studies, we anticipate an improvement of the live birth rate from 35% without surgery to 70% with surgery. To demonstrate this difference, 68 women need to be randomised.DiscussionHysteroscopic septum resection is worldwide considered as a standard procedure in women with a septate uterus. Solid evidence for this recommendation is lacking and data from randomised trials is urgently needed.Trial registrationDutch trial registry (NTR1676, 18th of February 2009).
Highlights
A septate uterus is a uterine anomaly that may affect reproductive outcome, and is associated with an increased risk for miscarriage, subfertility and preterm birth
Hysteroscopic septum resection is worldwide considered as a standard procedure in women with a septate uterus
Acknowledgements The authors wish to thank the doctors and research nurses in the cooperating hospitals for all their effort. Until this date, hysteroscopic septum resection of a septate uterus is standardly being performed worldwide in women of reproductive age and a wish to conceive [28, 29]. The evidence for this recommendation is based on retrospective and prospective comparative studies that suggest that restoration of the uterine morphology can potentially have a positive effect on live birth rate [9,10,11,12,13,14,15,16,17]
Summary
A septate uterus is a uterine anomaly that may affect reproductive outcome, and is associated with an increased risk for miscarriage, subfertility and preterm birth. The evidence is mainly based upon retrospective studies, in which improved pregnancy chances and live birth rates after hysteroscopic septum resection have been suggested [9,10,11,12,13,14,15,16,17]. The major flaw in most of the abovementioned studies is obviously the before/after design, since this will always favour the tested intervention as the prognosis without the intervention is usually good [18, 19] At this moment, in view of the limited quality of the performed studies it remains unclear whether removal of the septum will eliminate negative effects –if any- of a septate uterus, and whether the procedure does not cause harmful side effects [20]
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