Effects of Switching FSH Preparations on Sperm Parameters and Pregnancy: A Prospective Controlled Study

Abstract

Objective: To study the effect of switching to a follicle-stimulating hormone (FSH) preparation other than that to which infertile male patients have not had an effective response. Patients and methods: Seventy-four normogonadotropinemic, non-obstructive, oligozoospermic patients who were poor responders to the administration of highly purified FSH (hpFSH) (Group 1 (n = 22) and Group 3 (n = 15)) or to recombinant human FSH (rhFSH) (Group 2 (n = 22) and Group 4 (n = 15)) were selected for this prospective study. After 3 months of washout from treatment with the first FSH preparation of choice, rhFSH was administered to patients in Groups 1 and 4 and hpFSH to those in Groups 2 and 3. Serum luteinizing hormone, FSH, total testosterone levels, conventional sperm parameters, testicular volume, and the number of pregnancies were evaluated at study entry and after the first and second treatment cycles. Results: Comparing treatment groups, the greatest improvement in sperm parameters was recorded in the groups of patients prescribed the switch in FSH preparation. Group 1 had the greatest benefit from therapy, with the highest pregnancy rate after the second treatment cycle. Indeed, eight couples achieved pregnancy (36.4%), compared to Groups 2 (n = 4; 18.2%), 3 (n = 1; 6.7%), and 4 (n = 2; 13.3%) (p = 0.04). Conclusions: The results of this study suggest that a therapeutic scheme involving the "switching" of the FSH preparation yields better results than a protocol using the same FSH preparation for six months. These findings, if confirmed by further studies, will help us better design a treatment strategy with FSH for infertile patients with oligozoospermia.

Keywords: FSH; hpFSH; pregnancy; rhFSH; sperm concentration; switch; therapeutic scheme; total sperm count.

Figure 1

Conventional sperm parameters in Group 1. Group 1 consisted of patients treated with hpFSH followed by rhFSH at a dose of 150 IU three times a week for 3 months. The second cycle of therapy was prescribed after a 3-month washout from the first cycle (as per the provisions of the Italian Pharmacopeia) (Supplementary Figure S1). T0 shows parameters at baseline, T1 shows parameters after 3 months of hpFSH administration, andT2 shows parameters after 3 months of washout and a further 3 months of rhFSH administration. Abbreviations. FSH, follicle-stimulating hormone; hpFSH: highly purified FSH; rhFSH: recombinant human FSH.

Figure 2

Conventional sperm parameters in Group 2. Group 2 consisted of patients treated with rhFSH followed by hpFSH at a dose of 150 IU three times a week for 3 months. The second cycle of therapy was prescribed after a 3-month washout from the first cycle (as per the provisions of the Italian Pharmacopeia) (Supplementary Figure S1). T0 shows parameters at baseline, T1 shows parameters after 3 months of rhFSH administration, and T2 shows parameters after 3 months of washout and a further 3 months of hpFSH administration. Abbreviations. FSH, follicle-stimulating hormone; hpFSH: highly purified FSH; rhFSH: recombinant human FSH.

Figure 3

Conventional sperm parameters in Group 3. Group 3 consisted of patients treated with hpFSH followed by the same preparation at a dose of 150 IU three times a week for 3 months. The second cycle of therapy was prescribed after a 3-month washout from the first cycle (as per the provisions of the Italian Pharmacopeia) (Supplementary Figure S1). T0 shows parameters at baseline, T1 shows parameters after 3 months of hpFSH administration, and T2 shows parameters after 3 months of washout and a further 3 months of hpFSH administration. Abbreviations. FSH, follicle-stimulating hormone; hpFSH: highly purified FSH; rhFSH: recombinant human FSH.

Figure 4

Conventional sperm parameters in Group 4. Group 4 consisted of patients treated with rhFSH followed by the same preparation at a dose of 150 IU three times a week for 3 months. The second cycle of therapy was prescribed after a 3-month washout from the first cycle (as per the provisions of the Italian Pharmacopeia) (Supplementary Figure S1). T0 shows parameters at baseline, T1 shows parameters after 3 months of rhFSH administration, and T2 shows parameters after 3 months of washout and a further 3 months of rhFSH administration. Abbreviations. FSH, follicle-stimulating hormone; hpFSH: highly purified FSH; rhFSH: recombinant human FSH.

Figure 5

Sperm parameters at the end of the second treatment cycle (T2) with hpFSH followed by the administration of rhFSH (Group 1), rhFSH followed by the administration of hpFSH (Group 2), (hpFSH followed by the administration of the same FSH preparation (Group 3), and rhFSH followed by administration of the same FSH preparation (Group 4). The two different FSH preparations were administered at a dose of 150 IU three times a week for 3 months, and the second cycle of therapy was prescribed after a three-month washout from the first for all groups (as per the provisions of the Italian Pharmacopeia) (Supplementary Figure S1). Abbreviations. FSH, follicle-stimulating hormone; hpFSH: highly purified FSH; rhFSH: recombinant human FSH.