madman
Super Moderator
14:55 Optimal Restoration of Spermatogenesis following Testosterone Therapy using hCG and FSH
Key point here!
* Accordingly, one should not generalize our findings and propose that hCG/FSH therapy would benefit all infertile male patients.
The inherent limitation of our study is its retrospective nature without strict inclusion criteria, randomization, or patient monitoring (i.e., some data, such as hormone levels, are not completely captured). Specific limitations and selection biases also include the following: 1) exclusion of patients not undergoing a subsequent semen analysis after initial prescription of hCG/FSH therapy (n=102, potentially missing those patients unable to afford the high cost of hCG/FSH), 2) exclusion of patients without a documented history of testosterone use (n=39, raising the question of whether hCG/FSH therapy would benefit testosterone naïve infertile patients), and 3) exclusion of patients documented to be normospermic (>15 M/mL) despite being treated for infertility (n=8, highlighting whether gonadotropic therapy could improve not only sperm quantity but quality). Accordingly, one should not generalize our findings and propose that hCG/FSH therapy would benefit all infertile male patients.
Our study is also limited by its relatively short follow-up. Although the median time on hCG/FSH reboot to achieve the highest documented sperm concentration was 4.7 months, the upper quartile of therapy duration ranged from 8.7 to 29.4 months. Within this upper quartile, however, 73% of patients still demonstrated an improvement in their sperm concentrations vs. 74% of patients in the lower three quartiles. This raises the possibility that some patients may take longer to respond to hCG/FSH reboot therapy. Longer follow-up will be required to better understand this regimen’s safety and efficacy profile. Finally, we did not assess fertility outcomes in patients undergoing hCG/FSH reboot therapy as our IRB did not include calling patients for follow up. However, men with isolated hypogonadotropic hypogonadism treated with human Menopausal Gonadotropin ,a combination of urinary purified LH and FSH, can reliably achieve pregnancy despite having severe oligospermia or oligospermia(31). Thus, we posit that any improvement in sperm concentration secondary to hCG/FSH therapy represents a means to restore fertility in men with prior testosterone use.
Key to implementing standardized, guideline-based treatment protocols for the treatment of infertility secondary to testosterone use are prospective trials. To confirm these data, the authors are currently designing a multi-center, randomized, and controlled trial to assess hCG/FSH therapy in infertile men with prior testosterone use. Studies of importance should also include prospective trials comparing the efficacy of hCG monotherapy or hCG/Clomiphene to hCG/FSH, as well as the efficacy of hCG/FSH therapy in testosterone naïve patients(18).
Ultimately, the strength of this study is its size, representing the largest study to date investigating the utility of gonadotropic hCG/FSH therapy in restoring spermatogenesis in men with a history of testosterone use. Subjects followed a consistent medication regimen throughout the study, allowing appropriate analyses with semen analyses and hormonal testing at 3-month intervals. With hope of increased availability and reduced cost, hCG/FSH gonadotropic therapy may represent the optimal regimen for spermatogenic recovery in infertile men with a history of testosterone use