Study question: To comprehensively evaluate whether follicle stimulating hor- mone (FSH) administration to the male partner of idiopathic infertile couples improves pregnancy rate, both spontaneous and after assisted reproductive tech- nique (ART), using a meta-analytic approach and including controlled clinical trial. Summary answer: The administration of FSH to infertile men is reported in the literature since 1991, improving fertilisation and pregnancy rate. A significant increase in pregnancy rate after ART and male treatment with FSH was already shown in several studies, since FSH improves the sperm quality. FSH treatment could improve sperm quality and pregnancy rate in idiopathic infertile men. What is known already: The Cochrane Collaboration recently estimated the overall effect of FSH treatment of the man in couples attending ART, enrolled in randomised, controlled, clinical-trials. That meta-analysis demonstrated that FSH treatment significantly improves spontaneous pregnancy rate, whereas no improvement of pregnancy rate was observed after ART, using fixed and strict inclusion criteria. They excluded all trials in which the randomization was not provided leading to potential loss of useful information that could help clini- cians in their routinely practice. Study design, size, duration: We conducted a comprehensive literature search for controlled clinical trials in which FSH was administered for male idiopathic infertility, compared with placebo or no treatment. The randomization was not considered as inclusion criterion. We considered studies in which men with idiopathic infertility or subfertility were enrolled, chronicallty treated with any type of FSH, compared with placebo or no treatment. Participants/materials, setting, methods: We found 15 controlled clinical stud- ies. Concerning the type of FSH, eight studies included in the meta-analysis used recombinant FSH, whereas seven studies used purified FSH. Pregnancy rate, when evaluated, was considered spontaneous or after ART. Selected trials gave details about 1275 infertile-men, 614 treated with FSH and 661 not-treated. Main results and the role of chance: Among the 15 studies included, nine studies evaluated the spontaneous pregnancy rate, resulting in an overall im- provement of about 4.5 (CI 2.17–9.33 and I2 = 0%) (p < 0.001). Eight stud- ies evaluated pregnancy rate after ART, showing a significant improvement of about 1.60 (CI 1.08–2.37 and I2 = 43%) (p = 0.002). Sub-dividing studies ac- cording to the FSH preparations (purified or recombinant), the pregnancy rate improvement remained significant (p = 0.007 and p = 0.002, respectively). Elev- en studies considered sperm quality after FSH treatment, finding a significant improvement of sperm concentration (mean improvement of 2.66x106 millions/ mL, with CI 0.47–4.84, p = 0.02), but not of sperm motility (mean improvement of 1.22x106 millions/mL, with CI -0.07–2.52, p = 0.06). Finally, three trials evaluated testicular volume, showing a non-significant increase in men treated (mean increase of 1.35 mL, with CI -0.44–3.14, p = 0,14). Limitations, reason for caution: The heterogeneity of studies, together with the high risk of biases in this field of research could limit the strength of these results. Wider implications of the findings: The results of controlled clinical trials available in literature indicate an improvement of pregnancy rate after FSH ad- ministration to the male partner of infertile couples, both spontaneous and after ART. Study funding/competing interest(s): Funding by University(ies) – University of Modena and Reggio Emilia. Trial registration number: NA. Keywords: FSH, idiopathic male infertility, reproduction

Efficacy of follicle-stimulating hormone treatment in male idiopathic infertility: a meta-analysis / Santi, Daniele; Granata, Antonio; Simoni, Manuela. - (2015). (Intervento presentato al convegno 31ST ANNUAL MEETING OF ESHRE tenutosi a Lisbon nel 14-17 June 2015).

Efficacy of follicle-stimulating hormone treatment in male idiopathic infertility: a meta-analysis

Santi Daniele
;
Simoni Manuela
2015

Abstract

Study question: To comprehensively evaluate whether follicle stimulating hor- mone (FSH) administration to the male partner of idiopathic infertile couples improves pregnancy rate, both spontaneous and after assisted reproductive tech- nique (ART), using a meta-analytic approach and including controlled clinical trial. Summary answer: The administration of FSH to infertile men is reported in the literature since 1991, improving fertilisation and pregnancy rate. A significant increase in pregnancy rate after ART and male treatment with FSH was already shown in several studies, since FSH improves the sperm quality. FSH treatment could improve sperm quality and pregnancy rate in idiopathic infertile men. What is known already: The Cochrane Collaboration recently estimated the overall effect of FSH treatment of the man in couples attending ART, enrolled in randomised, controlled, clinical-trials. That meta-analysis demonstrated that FSH treatment significantly improves spontaneous pregnancy rate, whereas no improvement of pregnancy rate was observed after ART, using fixed and strict inclusion criteria. They excluded all trials in which the randomization was not provided leading to potential loss of useful information that could help clini- cians in their routinely practice. Study design, size, duration: We conducted a comprehensive literature search for controlled clinical trials in which FSH was administered for male idiopathic infertility, compared with placebo or no treatment. The randomization was not considered as inclusion criterion. We considered studies in which men with idiopathic infertility or subfertility were enrolled, chronicallty treated with any type of FSH, compared with placebo or no treatment. Participants/materials, setting, methods: We found 15 controlled clinical stud- ies. Concerning the type of FSH, eight studies included in the meta-analysis used recombinant FSH, whereas seven studies used purified FSH. Pregnancy rate, when evaluated, was considered spontaneous or after ART. Selected trials gave details about 1275 infertile-men, 614 treated with FSH and 661 not-treated. Main results and the role of chance: Among the 15 studies included, nine studies evaluated the spontaneous pregnancy rate, resulting in an overall im- provement of about 4.5 (CI 2.17–9.33 and I2 = 0%) (p < 0.001). Eight stud- ies evaluated pregnancy rate after ART, showing a significant improvement of about 1.60 (CI 1.08–2.37 and I2 = 43%) (p = 0.002). Sub-dividing studies ac- cording to the FSH preparations (purified or recombinant), the pregnancy rate improvement remained significant (p = 0.007 and p = 0.002, respectively). Elev- en studies considered sperm quality after FSH treatment, finding a significant improvement of sperm concentration (mean improvement of 2.66x106 millions/ mL, with CI 0.47–4.84, p = 0.02), but not of sperm motility (mean improvement of 1.22x106 millions/mL, with CI -0.07–2.52, p = 0.06). Finally, three trials evaluated testicular volume, showing a non-significant increase in men treated (mean increase of 1.35 mL, with CI -0.44–3.14, p = 0,14). Limitations, reason for caution: The heterogeneity of studies, together with the high risk of biases in this field of research could limit the strength of these results. Wider implications of the findings: The results of controlled clinical trials available in literature indicate an improvement of pregnancy rate after FSH ad- ministration to the male partner of infertile couples, both spontaneous and after ART. Study funding/competing interest(s): Funding by University(ies) – University of Modena and Reggio Emilia. Trial registration number: NA. Keywords: FSH, idiopathic male infertility, reproduction
2015
31ST ANNUAL MEETING OF ESHRE
Lisbon
14-17 June 2015
Santi, Daniele; Granata, Antonio; Simoni, Manuela
Efficacy of follicle-stimulating hormone treatment in male idiopathic infertility: a meta-analysis / Santi, Daniele; Granata, Antonio; Simoni, Manuela. - (2015). (Intervento presentato al convegno 31ST ANNUAL MEETING OF ESHRE tenutosi a Lisbon nel 14-17 June 2015).
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