Recombinant human follicle stimulating hormone for treatment of male idiopathic infertility:: a randomized, double-blind, placebo-controlled, clinical trial

被引:112
作者
Kamischke, A
Behre, HM
Bergmann, M
Simoni, M
Schäfer, T
Nieschlag, E
机构
[1] Univ Munster, Inst Reprod Med, D-48129 Munster, Germany
[2] Univ, Inst Anat & Cell Biol, D-06097 Halle, Germany
关键词
electron microscopy; male idiopathic infertility; randomized controlled clinical trial; recombinant human FSH; semen parameters;
D O I
10.1093/humrep/13.3.596
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
To examine the role of recombinant human follicle stimulating hormone (rhFSH) in male idiopathic infertility a randomized, double-blind, placebo-controlled study was performed. Of 211 patients screened, 67 were finally included. After two pre-examinations, patients were randomized and treated for 12 weeks, either with 150 IU rhFSH or with placebo. Examinations (physical examination, scrotal ultrasonography, semen analysis, hormone measurements, and in 31 patients electron microscopy (EM) of spermatozoa were performed 6 and 12 weeks after treatment initiation and 6 and 12 weeks after completion of treatment. Pregnancies were recorded for a further 3 months after the last examination. Of the 67 patients included in the study, 34 treated and 31 placebo patients could be analysed, In the treated group, FSH was elevated compared to baseline values (P < 0.001), At the end of treatment testicular volume in the treated group was increased compared to placebo (P < 0.05) and baseline (P < 0.001), Apart from an increase in sperm motility (P < 0.05) in the placebo group and in sperm DNA condensation (P < 0.001) in the treated group no significant changes were observed in semen parameters. Two spontaneous pregnancies in partners of men in the treated group and none in the placebo group occurred. However, two pregnancies occurred in partners of men in the placebo group induced by intrauterine insemination or intracytoplasmic sperm injection. In conclusion, at the chosen dose and duration, rhFSH did not lead to an improvement of conventional or EM sperm parameters nor to an increase in pregnancy rates, However, the increased testicular volume and sperm DNA condensation give reason for further investigations.
引用
收藏
页码:596 / 603
页数:8
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