Hysteroscopy in recurrent in-vitro fertilisation failure (TROPHY): a multicentre, randomised controlled trial

Tarek El-Toukhy, Rudi Campo, Yacoub Khalaf, Carla Tabanelli, Luca Gianaroli, Sylvie Gordts, Stephen Gordts, Greet Mestdagh, Tonko Mardesic, Jan Voboril, Gian Luigi Marchino, Chiara Benedetto, Talha Al-Shawaf, Luca Sabatini, Paul T Seed, Marco Gergolet, Grigoris Grimbizis, Hoda Harb, Aravinthan Coomarasamy

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The success rate of in vitro fertilisation remains modest and many patients undergo multiple treatment cycles. Previous studies suggested in vitro fertilisation outcome could be improved in patients who have experienced recurrent implantation failure if hysteroscopy was performed before starting a treatment cycle. However, those studies were of limited quality and a definitive randomised trial was needed.

The TROPHY trial was a single-blind multi-centre randomised controlled trial conducted in eight hospitals in four European countries. Women who had normal ultrasound of the uterine cavity and history of two to four failed in vitro fertilisation cycles were randomised to have either outpatient hysteroscopy or no hysteroscopy in the month before starting the subsequent treatment cycle. The trial used allocation concealment and minimisation for key prognostic variables, including age, body mass index and basal follicle stimulating hormone level. The primary outcome was live birth rate. Secondary outcomes were pregnancy, implantation and miscarriage rates and hysteroscopy findings. The trial was registered on the ISRCTN Registry (#ISRCTN35859078).

Seven hundred and two women younger than 38 years were randomly assigned between January 2010 and December 2013; 350 allocated to the outpatient hysteroscopy group and 352 to the control group. The live birth rate after in vitro fertilisation was 29% (102/350) in the hysteroscopy group and 29% (102/352) in the control group (relative risk [RR] 1·0; 95% confidence interval [CI] 0·79, 1·25, P=0·96). Hysteroscopy identified uterine abnormalities in 26% (85/323) of women. No hysteroscopy-related complications occurred. There were no significant differences in the pregnancy, implantation or miscarriage rates.

Outpatient hysteroscopy before in vitro fertilisation treatment in women with normal ultrasound of the uterine cavity and a history of two to four failed in vitro fertilisation treatment cycles does not improve the live birth rate.

The trial was funded by the European Society of Human Reproduction and Embryology, and the European Society for Gynaecological Endoscopy.
Original languageEnglish
Pages (from-to)2614-2621
Number of pages8
JournalThe Lancet
Issue number10038
Early online date27 Apr 2016
Publication statusPublished - 25 Jun 2016


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