title: Induction of spermatogenesis by recombinant follicle-stimulating hormone (puregon) in hypogonadotropic azoospermic men who failed to respond to human chorionic gonadotropin alone.
abstract: A multicenter, open-label, randomized efficacy and safety study was performed with combined human chorionic gonadotropin (hCG) and recombinant follicle-stimulating hormone (recFSH) (Puregon(R)) treatment to induce spermatogenesis in hypogonadotropic hypogonadal male patients. Patients were pretreated for 16 weeks with hCG to normalize testosterone levels. A total of 30 of 49 (61%) subjects had normalized testosterone levels but were still azoospermic after the hCG-alone phase. These patients were randomized into 2 treatment schemes with recFSH (2 x 225 IU recFSH per week [group A] or 3 x 150 IU recFSH per week [group B]), in combination with hCG for a period of 48 weeks. Total testosterone increased during the hCG-alone period from 1.08 and 1.22 ng/mL to 6.26 and 4.52 ng/mL for groups A and B, respectively. Combined gonadotropin treatment was effective in inducing spermatogenesis (sperm count >/=1 x 10(6)/mL) in 14 of 30 subjects (47%) and this was achieved after a median duration of treatment of approximately 5.5 months. Treatment time necessary for first sperm cells to appear in the ejaculate was related to the initial testicular volume. Subjects with a history of maldescended testes (11 of 30 subjects, 37%) showed a lower mean response to treatment as indicated by the relatively lower number of subjects reaching levels of at least 1 x 10(6) sperm cells per milliliter. Combined testicular volume increased during combined gonadotropin treatment from 11.4 to 24.0 mL. Although subjects with a history of maldescended testes had a lower starting testicular volume, subjects with and without a history of maldescended testes showed approximately the same relative increase in testicular volume. Total testosterone levels showed only a minor further increase during the combined gonadotropin treatment period. In conclusion, a weekly dose of 450 IU (3 x 150 IU or 2 x 225 IU) recFSH, in addition to hCG, was able to induce spermatogenesis in many hypogonadotropic azoospermic men who failed to respond to treatment with hCG alone.
authors.affiliation: Department of Endocrinology, The Royal Free Hospital, London, United Kingdom.
authors.forename: Pierre-Marc G
authors.initials: PM
authors.lastname: Bouloux
authors.forename: Eberhard
authors.initials: E
authors.lastname: Nieschlag
authors.forename: Henry G
authors.initials: HG
authors.lastname: Burger
authors.forename: Niels E
authors.initials: NE
authors.lastname: Skakkebaek
authors.forename: Frederick C W
authors.initials: FC
authors.lastname: Wu
authors.forename: David J
authors.initials: DJ
authors.lastname: Handelsman
authors.forename: Gordon H W
authors.initials: GH
authors.lastname: Baker
authors.forename: Robert
authors.initials: R
authors.lastname: Ochsenkuehn
authors.forename: Annemarie
authors.initials: A
authors.lastname: Syska
authors.forename: Robert I
authors.initials: RI
authors.lastname: McLachlan
authors.forename: Aleksander
authors.initials: A
authors.lastname: Giwercman
authors.forename: Ann J
authors.initials: AJ
authors.lastname: Conway
authors.forename: Leo
authors.initials: L
authors.lastname: Turner
authors.forename: Jacqueline H M
authors.initials: JH
authors.lastname: van Kuijk
authors.forename: Gerrit
authors.initials: G
authors.lastname: Voortman
mesh_terms: D000328:Adult; D006063:Chorionic Gonadotropin / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D043373:Follicle Stimulating Hormone, Human / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D008297:Male; D009845:Oligospermia / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D013091:Spermatogenesis / Q000187:drug effects*; D013737:Testis / Q000033:anatomy & histology / Q000187:drug effects; D013739:Testosterone / Q000097:blood; D016896:Treatment Outcome
chemical_list: D006063:Chorionic Gonadotropin; D043373:Follicle Stimulating Hormone, Human; D011994:Recombinant Proteins; D013739:Testosterone