Continuous Testosterone Therapy with Recombinant FSH & HCG Improves Semen Parameters: A Pilot Study

Abstract

ABSTRACT Introduction Male hypogonadism is characterized by inadequate production of Testosterone (T) and a deficiency in spermatogenesis. The main treatment of male hypogonadism is T therapy (TTh), which can disrupt normal hypothalamic-pituitary-gonadal axis function and cause oligospermia and/or azoospermia with testicular atrophy. Objective We evaluated the safety and efficacy of continuous intramuscular testosterone administration in combination with low doses of human chorionic gonadotropin (HCG) and recombinant follicle stimulating hormone (FSH) on semen parameters. Methods A total of 10 hypogonadal men on TTh, HCG, and FSH who had achieved pregnancy with their partners or had successful sperm retrievals were retrospectively identified. All of the men were maintained on continuous intramuscular testosterone therapy, HCG at 750 IU subcutaneously twice weekly and recombinant FSH 75 IU every other day. A semen analysis was performed in men who had not had vasectomy prior to or after starting therapy, and serum testosterone, estrogen, FSH, LH, hemoglobin and hematocrit levels, as well as a scrotal ultrasound for testicle size determination, were obtained. Results Of the 10 men with a mean(SD) age of 39.5(6.4) years) who underwent treatment, 7 achieved pregnancy naturally and 3 underwent sperm retrieval due to prior vasectomy, with successful sperm retrieval in all 3. Mean(SD) pretreatment T levels were 745(614) ng/dl, Estradiol 38.7(42.8) pg/ml, LH 0.18(0.24) IU/L, FSH 0.47(0.46) IU/L. Mean(SD) total motile sperm count (TMSC) was 1.43(2.99) million total motile sperm. Mean(SD) pretreatment testicular volume was 11.1(3.3)cc and post-treatment was 11(5.5) cc. Mean(SD) post-treatment T levels were 1185(482) ng/dl, Estradiol 26.0(16.9) pg/ml, LH 0.43(0.23) IU/L, FSH 1.78(0.91) IU/L, with TMSC 102.8(89.4) million. Conclusions Across a cohort of 10 men, TTh in combination with HCG and FSH resulted in resumption or increase in TMSC during treatment, resulting in either natural pregnancy or successful sperm retrieval and supporting the conclusion that TTh does not require cessation in men desiring fertility during TTh. Further prospective studies are required to validate these findings. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Vault Health