The May issue of Human Reproduction contained the first randomized controlled trial (RCT) of resection of a uterine septum. The journal issue also contained an editorial commenting on the study. The practice of removing a septum has undergone considerable controversy. The issue highlights one of the more vexing problems when trying to evaluate the usefulness of any surgical procedure. It is difficult to do randomized controlled trials when performing surgery. For example, in the early days of IVF, it was customary for patients that failed clomid treatment to go to FSH and intrauterine inseminations before going to IVF. Prior to using the FSH, many patients underwent a diagnostic laparoscopy to identify any endometriosis or pelvic adhesions. Endometriosis was a common finding where many of the findings were a Stage I endometriosis.
Now, suppose the surgeon had wanted to do a randomized trial where if a Stage I endometriosis was found, the surgeon would flip a coin and if it was heads, the surgeon would surgically remove all visible endometriosis but if it was tails, the surgeon would leave it alone. Not many women would agree to such a study because common sense would indicate that removing the endometriosis should improve the pregnancy rates and the surgeon would agree to this logic because some of the patients who had the endometriosis did in fact become pregnant after the surgery. When the RCT was finally done, (twice) the findings were hardly a robust endorsement for the diagnostic laparoscopy and today IVF has replaced the laparoscopy and the FSH-IUI in the treatment regimen.
The study done by Rikken et al (2021) was an international, multicenter randomized controlled trail evaluating the efficacy of hysteroscopic removal of a uterine septum. The study population was women who has a history of recurrent pregnancy loss, subfertility, or preterm birth. The primary outcome was live birth rate occurring within the first 12 months after the surgery. The study took longer than expected and was expanded to a multicenter study in order to have enough enrollees for statistical evaluation. The study had 80 enrollees randomly assigned to either surgery (40) or expectant management (40). One woman was excluded. The results demonstrated that 12/39 (31%) of the surgical enrollees had a live birth and 14/40 (35%) of the non-surgical group had a live birth. In the surgical group, there was one perforation.
The editorial critiquing this study identified the weaknesses of the study while acknowledging the difficulty of perform an RCT on a problem that does not occur frequently. The critique makes the following statement: ”The community of hysteroscopists should now feel somewhat embarrassed when realizing that septoplasty has been introduced into practice without sufficiently robust evidence of effectiveness.” [Hum. Reprod. 2021; 36:1166) The various professional groups are at odds about what to recommend with the American Society for Reproductive Medicine recommending surgery (2016) and the European Society of Human reproduction, the NICE, and the Royal College of Obstetricians and Gynaecologists not supporting septoplasty. The 2016 practice Committee guidelines pose the question: does treating a septum improve fertility in infertile women? The summary statement reads: Several observational studies indicate that hysteroscopic septum incision is associated with improved clinical pregnancy rates women with infertility (Grade C [indicates quality of the evidence]). A large, cohort study, published in 2020, did not support the use of surgery.
So, what is a patient to do and what would be a fair representation by surgeons? A patient can be informed of the sparsity of high-quality research recommending surgery and in fact the highest level published in this study demonstrated no benefit. The surgeon can then individualize the recommendations for or against surgery based upon that patient’s circumstances. The current study encourages surgeons to critically evaluate the need for surgery and may reduce significantly the number of unnecessary surgeries. While counterintuitive, there is little evidence to support the use of surgery for a uterine septum, even in patients with recurrent pregnancy loss (RPL). For the RPL patients, if all other evaluations have failed to disclose an etiology, including the more advanced evaluation of the endometrium, and the septum seems to be the only cause of the repeated losses, then perhaps, surgery is indicated.