Dear Editor,
We read with interest the online issue of Archives of Gynecology and Obstetrics of December 2009, Roy et al. [1] present a retrospective study on the effect of hysteroscopic septal resection for women with a history of recurrent miscarriages, preterm deliveries and infertility. The authors conclude that hysteroscopic metroplasty is a safe and effective procedure to improve obstetric outcome in these women. Unfortunately the interpretation of the results of this study has been subjected to a methodological pitfall.
This study, amongst many others evaluating the efficacy of hysteroscopic metroplasty, compares reproductive outcome in women before and after surgery, using these women as their own controls. This is not a fair comparison since the very reason for performing the surgery has been the poor reproductive outcome in the index pregnancy. These women could have miscarried by chance and still have a good chance of conceiving and having a live birth without any treatment. Making these before–after comparison will always favor the intervention [2, 3]. Therefore, we cannot agree with the conclusions of Roy et al. [1].
The only way to evaluate the efficacy of hysteroscopic metroplasty in women with recurrent miscarriage is to perform a randomized controlled trial. We disagree with the comments of Roy et al. that performing such a trial would not be possible due to ethical reasons.
In our opinion, it is unethical to perform treatment without the knowledge of the effectiveness of this treatment. We have recently launched the TRUST trial (The Randomized Uterine Septum Transsection trial: NTR1676) that randomizes women with recurrent miscarriage between hysteroscopic metroplasty and expectant management. The results of this trial will answer the question, whether hysteroscopic metroplasty is a safe and effective method for improving reproductive outcome. Roy et al. are warmly invited to participate in our study.
Conflict of interest statement
None.
Open Access
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References
- 1.Roy KK, Singla S, Baruah J, Kumar S, Sharma JB, Karmakar D (2009) Reproductive outcome following hysteroscopic septal resection in patients with infertility and recurrent abortions. Arch Gynecol Obstet (Epub ahead of print) [DOI] [PubMed]
- 2.Mastenbroek S, Twisk M, Goddijn M, van der Veen F, Repping S, Bossuyt PM, Korevaar JC, Heineman MJ. PGD—a model to evaluate efficacy? Fertil Steril. 2006;85(2):534–535. doi: 10.1016/j.fertnstert.2005.11.008. [DOI] [PubMed] [Google Scholar]
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