In 2006, Evers and Collins published a famous meta-analysis in the Cochrane database, indicating the discredit on varicocele repair [18]. This meta-analysis included 7 randomized control trials. The judgment criterion was the birth rate. Based on a non-significant difference in birth rate between the two groups (22% in the treatment group, vs.19% in the control group), the authors concluded that “There is no evidence that treatment of varicocele in men from couples with otherwise unexplained subfertility improves the couple's chance of conception”. Following this publication, several societies, including the European Association of Urology (EAU) revised their guidelines, considering: Treatment of varicocele to achieve pregnancy in infertile couples remains controversial and all studies to date have been subject to criticism [19].
However, critical analysis of the included studies pointing out several biases, notably that infraclinical varicoceles and patients with normal semen parameters were included. Since that time, several meta-analyses, excluding the biased studies [20] or including complementary data from good quality observational studies [10] have been published, showing a significant improvement in the pregnancy rate.
Finally, a new randomized controlled trial including 148 infertile men with a clinical varicocele, and altered semen parameters was published by Abdel-meguid et al. [21] They observed a significant difference in favor of varicocele treatment (OR =3.04 (1.33-6.95)). Subsequently, Baazzem et al. published a new meta-analysis that found an OR at 2.69 (1.16 – 6.24) between varicocele treatment and surveillance [9]. They also clearly highlighted the impact of varicocele treatment on all semen parameters (compared to controls, OR = 12.3 (9.45 – 15.19) for sperm concentration, 0.86 (7.07 – 14.65) for total motility, 9.69 (4.86 – 14.52) for progressive motility [5]. This positive impact of varicocele treatment on semen parameters has been supported by two recent meta-analyses [22, 23]. Moreover, Baazzem et al. included in their study new interesting end points that were not analyzed previously, and that were improved following the treatment (oxidative stress, sperm DNA damage, sperm ultrastructure) [5]. In conclusion, the benefits of varicocele treatment seem much more evident than in the last decade. Considering the quality of studies rendered so far, it seemed difficult to come up with a definite conclusion, the last meta-analysis from the Cochrane (2012) finally favored treatment, with a combined OR 2.39 (95% CI 1.56 to 3.66), and a calculated number of patients needing to be treated for an additional beneficial outcome of 7 [24].
Concerning the techniques of varicocele treatment, recent comparisons figure that sub-inguinal microsurgical technique is the treatment of choice, allowing the lowest recurrence rate (0.8 to 4%), without exposing to severe complications, [12, 22] recommending it also as first line treatment [25]. Shiraishi et al. compared the results and complications of retroperitoneal, microsurgical subinguinal, and high inguinal approaches in the treatment of varicoceles [26], and concluded that significant postoperative improvements in sperm concentration and motility were observed after all approaches, but results were observed sooner and showed higher sperm concentration and motility after the use of the microsurgical approaches.
However, data concerning the percutaneous embolization should be regarded cautiously, as they remain scarce. A recent radiological study, without surgical group concluded arbitrarily that “the only situation in which PE has failed to show itself equal or superior to other established techniques is in the case of bilateral varicocele” placing PE as a new gold standard in most cases [27].
Considering this ongoing debate, our study aimed to compare thoroughly the results of SIS and PE, in order to draw conclusions about how to treat varicocele optimally. In this study, both groups showed a significant improvement in sperm count, sperm progressive motility (only at 6 months) and the TMSC (at 3, 6, 9 months) postoperatively. There was no significant difference according to postoperative semen parameters between the two groups, except a higher sperm concentration at 6 months postoperatively in group 2. However, it must be noted that preoperatively, there was a tendency for a higher sperm concentration in group 2 (8.63 ×106/ml, vs. 6.23 ×106/ml in group 1). In addition, the postoperative TMSC which is a parameter well correlated with fecundability was statistically non-significant between the both groups at any times. Therefore, our results fully agree with many studies that both the procedures provide similar increase in sperm quality [28]. Also, studies favoring higher results after SIS than PE only show marginal differences [14].
Concerning the pregnancy rate, we observed roughly the same result in both groups. Analysis of the literature shows that one third of couples achieve a spontaneous pregnancy which is frequently reported by studies that had sufficient follow-up [29]. Nevertheless, contrarily to the generally admitted idea that following varicocele treatment, semen improvement occurs progressively during the first year, we observed for all parameters (concentration, motility, vitality, normal forms and TMSC) a sharp rebound at 3 months, followed by a slight decrease but a level at the last analysis remaining higher than preoperatively. Recently Al Bakri et al reported similarly, that sperm parameters improve by 3 months following varicocele repair and then no more improvement by 6 months or longer [30]. The cause of such phenomenon remains unclear.
Concerning post-operative complications, it is difficult to know from the literature the frequency of complications for each procedure, due to heterogeneous report of them (no use of validated classification, difficulty to identify mild side effects, inclusion of recurrence). With only 3 patients reporting mild post-operative complications in group 1 and no one in group 2, we confirm that the two techniques are safe procedures. Our methodology does not enable us to verify if the PE exposes to higher recurrence rates than SIS [31]. On the other hand, we did not observe that hydrocele is more frequent after subinguinal technique as it is reported in the literature [32, 33]. Obviously, the number was too low to draw any meaningful conclusions but the key message is that complications are minor and of little consequence with these 2 procedures.
Post-operative pain and its duration seemed less in the PE group, with no patient reporting anything above 2/5 in this group. Many patients in the SIS group describe uncomfortable feeling at the incision site, rather than pain, especially at the end of the day without any evidence of abnormal clinical or radiological examination. Obviously, we found that a pain level above 2 was associated with longer sick leave in the SIS group. Taking this into account, one may argue that patients who care about an expedient recovery may be advised to perform PE rather than SIS; however, it is difficult to recommend it as the consumption of analgesia was not assessed.
Overall satisfaction was high in both groups concerning the pre-operative information as well as post-operative outcomes. This high satisfaction may be understood, for the preoperative assessment, by the systematic discussion with the couple of the two modalities of treatment, together with the use of an informational booklet written by the French Urology Association, and the fact that the patient participated in the choice of treatment.
For the postoperative assessment, satisfaction may reflect the occurrence of a pregnancy without need of assisted reproductive techniques (ART) for one in 3 patients, and in the absence of pregnancy, the mini-invasiveness of treatments, together with an improvement of semen quality that may have a positive impact on the outcome of ART [34].
There were however a few limitations that must be noted when interpreting our results, mainly the small sample size, the fact that these data come from only one center, the absence of randomization of treatment and subjectivity of phone interview questionnaire. Qualitative results must always be interpreted with caution. Pain endurance, pain intensity, what one individual considers a hindrance to activity and return to normal life are all eminently subjective variables.
It is also important to note that 8 patients (16.3%) underwent bilateral SIS while all PE were left sided. This difference may affect the comparability and interpretation of our results.
Another difficulty comes from patient’s compliance to perform a semen collection at all the designated times. One in three patients only achieved the one-year full protocol, and we had difficulties to collect the semen analysis at 9 and 12 month. To deal with this issue, we created the variable “last analysis”, meaning the last semen analysis performed for each patient, but obviously, interpretation of results should again be viewed with caution as it renders difficult to analyze precisely fluctuations within the study period.
Our study does not compare the two techniques from a medico-economic point of view. Many studies have shown that in various medical systems, varicocele surgery is more cost effective than assisted reproduction techniques [31, 35]. However, we found that it was not valuable to compare the two techniques, taking into account that costs are greatly dependent from one country to another. It must be noted, however, that the 2 techniques are always performed in outpatient day-care, and thus, there is no obvious difference in hospitalization cost between the PE and SIS [33].