The Role of FSH Therapy for Male Infertility in the Era of ICSI


The First World Congress On: Controversies in Obstetrics, Gynecology & InfertilityPrague, Czech Republic - 1999

Available for download in Word Document format


pFSH therapy for the male suffering from severe OTA or non-obstructive “maturation arrest” azoospermia is beneficial, improving fertilization and implantation rates. It is possible that improved embryo quality, due to improved paternal factor, contributes to these results.


Our group presented recently that pFSH (Metrodin) administered to the male partner in OTA cases improved sperm electron microscopical ultrastructure, with improvement of fertilization rate in vitro and increased pregnancy rates(1).

In this study we treated the male partners with pFSH prior to IVF-ICSI cycle and presented significantly better implantation potential of IVF-ICSI embryos and in the second phase of the trial we utilized this experience in azoospermic males suffering from “maturation arrest” proven by testicular biopsy, treated with prolonged pFSH (Metrodin) therapy and improved significantly the fertilization and pregnancy rates in the next IVF-ICSI, testicular surgical sperm extraction cycle.

Material and Methods

112 IVF-ICSI cycle patients without pregnancy achievement were allocated prospectively at random in the study (treated) and control (non-treated) groups. The males received long-term treatment with pFSH (Metrodin) 1 ampule injected intramuscularly daily for 50-70 consecutive days prior to their next IVF-ICSI cycle.

In another cohort of 36 non-obstructive azoospermic males, 15 were diagnosed as “maturation arrest” cases by testicular biopsy and presented poor results in terms of motile sperm retrieval on surgical testicular sperm extraction and low fertilization potential of the oocytes. Patients again received long-term (90-days) 1 ampule Metrodin therapy daily and repeated their IVF-ICSI surgical sperm extraction cycle, with repeated evaluation of testicular histology.


IVF-ICSI and Metrodin therapy results are presented in Table 1. A higher pregnancy rate was documented in the treated group (35% vs 15.9%). A significant increase in implantation rate was observed in the pFSH therapy group (15.5% vs 6.5%, p<0.05). A trend towards increased number of grade A embryos was observed in the group treated with pFSH (2.2±1.6 vs 1.6±1.6).

The cohort of 15 non-obstructive azoospermic males (Table 2) treated with pFSH, group II, was compared to non-treated cohort, group I, and compared to control group III of obstructive azoospermic males treated concomitantly with IVF-ICSI surgical sperm extraction. We presented an obvious increase in clinical pregnancy and implantation rates in the pFSH treated group, with improvement of the histology in repeated testicular biopsy during IVF-ICSI, surgical sperm extraction cycle. 


Our findings suggest that pFSH therapy for the male partner should be considered as adjuvant treatment in couples undergoing IVF-ICSI cycles in severe OTA patients or non-obstructive azoospermic cases diagnosed by testicular biopsy as “maturation arrest”. These results may imply that pFSH therapy improves sperm ultramorphology leading to better embryo quality, resulting in blastocysts with better implantation potential.

These findings confirm that there is a clear paternal contribution to embryo quality with adequate blastocyst formation and implantation(2). Larger cohorts of patients should be investigated in multicentric studies and Metrodin should be compared to recombinant FSH (Gonal-F) as a potential substitutional drug to pFSH.




1) Ben-Rafael Z. et al. Follicle – stimulating hormone treatment for the male prior in vitro fertilization: the impact on sperm microstructure and fertilization potential. Fertil.Steril. Accepted for publication 1999.

2) Janny L. et al. Evidence for a strong paternal effect on human preimplantation embryo development and blastocyst formation. Molecular Reprod. Develop. 38:36, 1994.

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