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

Area of Science:

• Reproductive Medicine
• Gynecologic Surgery
• Clinical Trials

Background:

• A septate uterus is a uterine anomaly associated with adverse reproductive outcomes, including miscarriage, subfertility, and preterm birth.
• The effectiveness and safety of hysteroscopic septum resection for treating septate uterus remain debated due to a lack of robust evidence.

Purpose of the Study:

• To evaluate whether hysteroscopic septum resection improves reproductive outcomes in women diagnosed with a septate uterus.
• To compare the efficacy of hysteroscopic septum resection versus expectant management in women with recurrent miscarriage or subfertility due to a septate uterus.

Main Methods:

• A multi-center randomized controlled trial was conducted.
• Participants with a septate uterus and recurrent miscarriage or subfertility were randomized to either hysteroscopic septum resection or expectant management.
• The primary outcome was live birth rate (delivery beyond 24 weeks gestation).

Main Results:

• The study aimed to detect a significant improvement in live birth rate from an anticipated 35% without surgery to 70% with surgery.
• A sample size of 68 women was calculated to demonstrate this difference.
• Kaplan-Meier curves were used to estimate cumulative live birth rates over time.

Conclusions:

• Hysteroscopic septum resection is considered a standard procedure for septate uterus, but lacks strong supporting evidence from randomized trials.
• Randomized trial data are urgently needed to confirm the benefits and safety of this surgical intervention.