In this era of cost-consciousness and containment, it is imperative to examine not only treatment outcomes but also cost of these treatments. With improvements of in vitro fertilization outcome and continued development of less-invasive sperm retrieval methods, physicians and couples must examine all options available after surgical sterilization. Vasectomy reversal remains the gold standard of treatment; however, certain situations may be present in which sperm acquisition/in vitro fertilization may be a better option. A physician’s responsibility is to present all options with the pros and cons of each, including cost, to help arrive at an informed decision.
In the modern era of in vitro fertilization (IVF), the options for couples who have obstructive azoospermia (OA) have improved tremendously. With the advent and improvement of intracytoplasmic sperm injection (ICSI), couples who previously had limited choices for conceiving after a vasectomy (eg, vasectomy reversal [VR] or donor sperm) now may have a simple sperm retrieval (SR) in conjunction with IVF in order to achieve a biologic pregnancy. With these techniques many centers are reporting success rates of more than 50% per cycle and, although the cost of treatment tends to be higher than with surgical reconstruction, IVF provides a realistic alterative. In this era of cost-consciousness and containment, however, and limited health care resources for much of the population, it is important to examine all the factors and consequences that are involved with both surgical reconstruction as well as SR/IVF/ICSI. Many factors need to be considered when making a decision and there are no randomized controlled studies to use for guidance. Factors to consider include risks for procedures, cost-effectiveness, number of children desired, female fertility issues (including taking into account the time to conceive after VR), and future contraception needs.
This article examines these factors, presents the advantages and disadvantages of each approach, and suggests situations where one modality may be superior to another.
Surgical reconstruction for obstructive azoospermia
The most common cause of OA is vasectomy, although there are infectious, congenital, traumatic, and idiopathic causes. The two types of repair, vasovasostomy (VV) and vasoepididymostomy (EV), are described in detail elsewhere. Typically, patency and pregnancy rates are higher for VV than EV, and these rates are surgeon specific. Most series report patency rates of greater than 85% for VV and approximately 60% to 70% for EV, with variable pregnancy outcomes. The cost for VR varies based on surgeons’ fees, operative costs, and anesthesia fees. It is important for patients and providers to compare real costs and success rates specific to their situations rather than generalized costs that may not reflect the local marketplace. This is true for surgical reconstruction and IVF.
Sperm retrieval with in vitro fertilization/intracytoplasmic sperm injection
As success rates for IVF have improved, the use of this technique has increased. As more programs are becoming adept at working with testicular and epididymal sperm, the success rates for SR/IVF/ICSI have improved dramatically without a significant rise in costs. This has led to improved cost-effectiveness for this procedure. Furthermore, as pregnancy rates have risen, the number of embryos transferred has declined, leading to a smaller number of multiple gestation pregnancies. As several investigators have reported, however, the success rate of SR/IVF/ICSI must approach unrealistically high percentages in order to counteract the significant difference in cost as compared to VR.
In order to fully understand the factors related to success, one must be somewhat familiar with the IVF procedure. IVF involves the use of exogenous gonadotropins to bring about multifollicular growth. After monitoring the growth and maturation of the follicles, the oocytes are retrieved though an ultrasound-guided transvaginal percutaneous puncture and aspiration of the follicles. In the case of obstructive azoospermia, the retrieved sperm are used for ICSI to fertilize the eggs. The resultant embryos, typically on day 3 or 5 after oocyte retrieval, then are transferred into the woman’s uterus. The number of embryos placed in the uterus varies with different institutions and usually takes into account the female partner’s age and the embryo quality along with success or failure from any previous cycles. Fortunately, pregnancy with ICSI has been shown to be possible with spermatozoa from almost any source, including testis, epididymis, vas deferens, and the ejaculate, so that the success of assisted reproductive technology (ART) essentially relates mainly to female factors (female infertility issues, age, and oocyte quality and quantity). The single greatest prognostic factor for IVF success is the age of the female partner. With the increasing success of the IVF procedure, there has been an emphasis of late on considering single embryo transfers as a means of avoiding the complications and costs of multiple pregnancies. As a result of lower per-cycle pregnancy rates with single versus multiple embryo transfers and because most of the cost of ART is not covered by insurance, this push has not translated into routine practice. Risks for the IVF process that need to be considered include the risk for multiples and their complications, injuries as a result of stimulation or oocyte retrieval, ovarian hyperstimulation syndrome, and the slight elevation in congenital anomalies.
Sperm retrieval with in vitro fertilization/intracytoplasmic sperm injection
As success rates for IVF have improved, the use of this technique has increased. As more programs are becoming adept at working with testicular and epididymal sperm, the success rates for SR/IVF/ICSI have improved dramatically without a significant rise in costs. This has led to improved cost-effectiveness for this procedure. Furthermore, as pregnancy rates have risen, the number of embryos transferred has declined, leading to a smaller number of multiple gestation pregnancies. As several investigators have reported, however, the success rate of SR/IVF/ICSI must approach unrealistically high percentages in order to counteract the significant difference in cost as compared to VR.
In order to fully understand the factors related to success, one must be somewhat familiar with the IVF procedure. IVF involves the use of exogenous gonadotropins to bring about multifollicular growth. After monitoring the growth and maturation of the follicles, the oocytes are retrieved though an ultrasound-guided transvaginal percutaneous puncture and aspiration of the follicles. In the case of obstructive azoospermia, the retrieved sperm are used for ICSI to fertilize the eggs. The resultant embryos, typically on day 3 or 5 after oocyte retrieval, then are transferred into the woman’s uterus. The number of embryos placed in the uterus varies with different institutions and usually takes into account the female partner’s age and the embryo quality along with success or failure from any previous cycles. Fortunately, pregnancy with ICSI has been shown to be possible with spermatozoa from almost any source, including testis, epididymis, vas deferens, and the ejaculate, so that the success of assisted reproductive technology (ART) essentially relates mainly to female factors (female infertility issues, age, and oocyte quality and quantity). The single greatest prognostic factor for IVF success is the age of the female partner. With the increasing success of the IVF procedure, there has been an emphasis of late on considering single embryo transfers as a means of avoiding the complications and costs of multiple pregnancies. As a result of lower per-cycle pregnancy rates with single versus multiple embryo transfers and because most of the cost of ART is not covered by insurance, this push has not translated into routine practice. Risks for the IVF process that need to be considered include the risk for multiples and their complications, injuries as a result of stimulation or oocyte retrieval, ovarian hyperstimulation syndrome, and the slight elevation in congenital anomalies.
Female factors
Several studies have examined female partner age as a predictor of VR success. Gerrard and colleagues examined success rates of VRs in 294 patients and pregnancy rates for various female partner ages. They found pregnancy rates above 50% in the age categories below age 40 but only 14% in those couples in which the female partner was over age 40. They concluded that couples in which the female partner is over age 40 should have careful preoperative counseling about their chance for pregnancy, whether or not they choose VR or IVF. Silber and Grotjan summarized their data on 1735 patients who could be contacted out of a total of 4010 patients who underwent VR and found that the one factor that had the most significant impact on pregnancy rate was the age of the female partner. They reported pregnancy rates of over 90% when the female partner was under age 30 but less than 55% when the female partner was over age 40. Another finding to consider from this study was that 23% of the pregnancies did not occur until more than 2 years after VR. These 2 years may be enough to cause a significant diminution in female partner reproductive potential, commonly referred to as ovarian reserve (discussed later).
The Society for Assisted Reproductive Technology’s (SART) data highlight the importance of female partner age when considering ART. When examining the literature, however, it is important to realize that in all age groups, ART success has been improving steadily since its inception. Due to this improvement over time, it is imperative that one consider the year in which a study reports the ART success it is using to compare with VR, if one is to make a meaningful comparison. A study by Deck and colleagues used a result of 8% for the live birth rate in women over age 36, based on the results of a 1997 study group, to conclude that vasectomy was still cost effective in couples with an older female partner. Physicians must consider not only the rates for ART success quoted in any given study and the year it was written but also the rates in their own center or the center to which they refer patients to decide if the results for a study population can be extrapolated to their patient population. An examination of the SART national numbers for the year 2006, for cycles that include only male factor, shows that pregnancy rates range from a high of 49% (women aged <35), to 41% (ages 35–37), to 30% (ages 38–40), to 19% (ages 41–42), and to 13% (ages 43–44). These numbers are not exclusive to VR but include all male factors. It is presumed that the majority of patients undergoing a vasectomy have previously proved male fertility potential, so these data may underestimate the success of ART in this subset of male infertility. Hsieh used Markov modeling, a form of decision analysis in which a hypothetical patient proceeds through health states over time based on predefined probabilities and costs. When considering cost, physicians need to consider both partners when comparing VR with SR/IVF. The authors concluded that ART yields a higher pregnancy rate but does so at a higher cost than does VR. When the authors performed a sensitivity analysis to determine which variables had an impact on the Markov model, they found that female partner age had a greater effect on cost-effectiveness than did the obstructive interval. Many cost analysis studies suggest that, particularly in couples with a younger female partner who have no other fertility issues, VR is more cost effective ( Table 1 ). However, due to the excellent ART success rates in this population, couples who desire only one child might prefer ART over VR. If the couple does opt for ART in this situation, then a single embryo transfer should also be strongly considered. The 2006 SART data also showed a 32% twin and 2% triplet or higher order multiple rate with ART in the under age 35 group with an average of 2.3 embryos transferred. In the over age 38 group, Hsieh’s Markov modeling suggests that ART may be more cost effective than VR, although some of this also is dependent on the time from vasectomy. What about those in the group that is over age 42? With either treatment they are going to have a low likelihood of success. Would this group be better off with the low probability but also lower cost option of VR to have at least some chance to conceive? There are no trials to guide the decision process. In this case, it is important to counsel such couples on the better pregnancy success option of using donor eggs and the high rate of aneuploidy in any conceptions using the female partner’s own eggs. As in the Silber study, it is usual to present VR pregnancy rates as cumulative rates over time and not per month whereas IVF success usually is reported as per month as represented per cycle. This is in part because of the one-time cost of the VR whereas IVF treatment incurs costs with each cycle. This does not make for an entirely fair comparison, however. Malizia and colleagues retrospectively studied 6164 patients undergoing 14,248 cycles and analyzed cumulative success rates with IVF. These patients went through up to 6 cycles with a mean of 2.3 cycles. Success again varied with female partner age. Among patients who were younger than 35 years of age, the live birth rates (not just pregnancy) after six cycles were 86% (optimistic calculation) and 65% (conservative calculation). Among patients who were 40 years of age or older, the corresponding rates were 42% (optimistic) and 23% (conservative). The differences between the optimistic and conservative calculations relates to how dropouts were handled. These numbers are in the same range as Silber’s, which allowed for a much longer follow-up time period. The Malizia study was done in a state that has mandated IVF coverage and for most patients, in nonmandated states, the cost of 6 cycles would be prohibitive. The mean number of cycles, however, was less than 2.5. They also noted that their pregnancy and live birth rates were lower than the national average for 2005 (date for completion of the study). For women under age 35, they reported a first-cycle live birth rate of 33%, which is slightly lower than the live birth rate per cycle start (all starts, not only first starts) of 37% reported by SART for women under age 35 for 2005. They may, therefore, underestimate the cumulative pregnancy rates expected with ART. The Markov modeling by Hseih (discussed previously) also showed that with increasing willingness to pay (WTP), ART was more cost effective over a wider range of female partner age. It must, therefore, be factored in how much a couple can pay and how long, for both medical and social reasons, can they wait.
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