The randomised uterine septum transsection trial (TRUST): design and protocol

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).Electronic supplementary materialThe online version of this article (10.1186/s12905-018-0637-6) contains supplementary material, which is available to authorized users.

Comparison and appraisal of (inter)national recurrent pregnancy loss guidelines

“…Likewise, the ESHRE guideline concludes that the effect of septum resection should be evaluated in randomized controlled trials and that other uterine reconstructions are not recommended. The TRUST trial (Dutch trial number: NTR 1676) is currently investigating whether hysteroscopic septum resection improves the reproductive outcome in women with a septate uterus (Rikken et al, 2018). Regarding acquired intrauterine malformations, the ESHRE and ASRM conclude that there is insufficient evidence for the removal of fibroids or adhesions (Asherman syndrome).…”

Reproductive Implications and Management of Congenital Uterine Anomalies

“…A Cochrane review published in 2017 did not identify any published randomised controlled studies assessing the efficacy in pregnancy outcomes after hysteroscopic metroplasty. The Randomised Uterine Septum Transsection Trial (TRUST) to assess whether hysteroscopic septum resection improves reproductive outcomes in women with a septate uterus and a history of (recurrent) miscarriage, subfertility or preterm birth is a multicentre study currently underway in the Netherlands, Iran and USA, with results awaited. A pilot single‐centred randomised controlled trial of hysteroscopic septal resection in women with septate uteri, history of miscarriage or preterm birth, or infertility had been proposed in the UK, but has not been feasible because of difficulty in recruiting women and clinicians to participate – a problem experienced by the authors of the TRUST trial also…”

Tubal Flushing Treatment for Unexplained Infertility

“…However, a systematic review, a large cohort study, and the TRUST trial showed no benefits from hysteroscopic septum resection in infertile women in comparison to expectant management. [63][64][65] But it is possible that women treated expectantly underwent diagnostic procedures with tubal flushing for diagnosing the septum (i.e., HSG, sonohysterography, hysteroscopy). These diagnostic procedures can mask the effect of tubal flushing associated with metroplasty, when the group without surgical intervention underwent tubal flushing according to study protocols, which are focused directly on surgical procedure, but not on the associated tubal flushing.…”