Real-world evidence analysis of the follicle-stimulating hormone use in male idiopathic infertility

Santi, Daniele; Spaggiari, Giorgia; Granata, Antonio R. M.; Simoni, Manuela

doi:10.1016/j.bpobgyn.2022.04.004

Cited by 7 publications

(20 citation statements)

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“…To this purpose, only a real-world data analysis considering the whole ART center experience could provide a strong basis on which statistical models could produce useful information. 47 This analysis returns an important result, underlining the importance of variables deriving from both partners for the final success. In this setting, our results are not able to provide an unambiguous answer to the starting question since data about couples' medical treatments are missing in our dataset.…”

Section: Discussionmentioning

confidence: 99%

“…However, before answering this question it is important to get a comprehensive understanding of the entire ART path. To this purpose, only a real‐world data analysis considering the whole ART center experience could provide a strong basis on which statistical models could produce useful information 47 . This analysis returns an important result, underlining the importance of variables deriving from both partners for the final success.…”

Section: Discussionmentioning

confidence: 99%

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Which sperm parameter limits could really guide the clinical decision in assisted reproduction?

et al. 2022

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Background The predictive role of sperm motility and morphology was recently detected in a large sample of more than 20000 assisted reproductive technology (ART) fresh cycles. However, the complete ART procedure consisted of both fresh and frozen‐embryos transfers and only a comprehensive evaluation of the entire process could really confirm if these parameters really predict the ART success. The aim of the study was to evaluate which sperm parameter could predict the success of ART. Methods A retrospective, real‐world data analysis was performed, enrolling all couples attending ART from 2008 to 2021, including both fresh and frozen cycles and both in vitro fertilization (IVF) and intra‐cytoplasmic sperm injection (ICSI) procedures. Results Fresh cycles success (considering live birth rate) was predicted by female age (1.04 [1.02–1.06]), injected oocytes (0.96 [0.93–0.99]), embryo number (0.79 [0.75–0.83]) and progressive sperm motility (0.98 [0.97‐0.99]). On the contrary, frozen cycle outcomes were predicted only by sperm motility (0.97 [0.95–0.99]). This prediction was confirmed in IVF but not in ICSI cycles. Conclusion Both female and male parameters predicted the ART success considering the entire path. However, frozen cycle success was predicted only by progressive sperm motility in IVF cycles, suggesting that the potential amelioration of this male parameter is relevant to improve ART success. Those couples expected to obtain the highest embryos after fertilization (low female age and better semen parameters) will have more attempts with frozen cycles and thus would benefit from a potential treatment focused to improve sperm parameters.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Which sperm parameter limits could really guide the clinical decision in assisted reproduction?

et al. 2022

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“…In this complex scenario, the improvement of male infertility management and treatment is mandatory, representing the fundamental strategy to offer more chances to infertile couples and to optimize the use of ART. In male idiopathic infertility, both hormonal and non‐hormonal therapies have been empirically proposed 10,11 . The administration of exogenous follicle‐stimulating hormone (FSH) was proposed to stimulate testicular function and sperm production, in analogy with the gold standard therapeutic approach in men with hypogonadotropic hypogonadism 12,13 .…”

Section: Introductionmentioning

confidence: 99%

“…Indeed, RWD refers to data collected in the routine clinical practice, rather than in the context of a clinical trial, reflecting the clinician choice based on patients’ clinical characteristics and preferences, and not defined a priori. Although heterogeneous by definition, RWD analysis provides new insights beyond those addressed by conventional clinical trials, representing a valuable additional source of information in decision‐making 10,29 . However, most of our knowledge about FSH treatment efficacy in male idiopathic infertility comes from controlled clinical trials, and only limited data are currently available on the real FSH effectiveness in clinical practice.…”

Section: Introductionmentioning

confidence: 99%

Follicle‐stimulating hormone effectiveness in male idiopathic infertility: What happens in daily practice?

et al. 2022

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Objectives: To assess the effectiveness of follicle-stimulating hormone (FSH) administration in male idiopathic infertility in a clinical setting. Methods:A retrospective real-world study was carried out, including all consecutive FSH-treated infertile men attending the Andrology Unit of Modena (Italy) from June 2015 to May 2022. Medical history, physical and andrological examinations, hormonal and seminal parameters, therapeutic management and pregnancy data were collected. The primary endpoint was the number of pregnancies obtained after FSH administration, whereas semen parameters change was the secondary outcome.Results: A total of 194 of 362 (53.6%) infertile men, eligible according to the Italian Health System regulations, were treated with FSH (mean age 37.9 ± 6.1 years). Following FSH administration (mean therapy duration 9.1 ± 7.1 months), 43 pregnancies were recorded (27.6%), of which 22 occurred naturally and 21 after assisted reproduction.A significant increase in sperm concentration (9.9 ± 12.2 vs. 18.9 ± 38.9 million/mL, p = 0.045) was detected after treatment, together with a significant increase in normozoospermia (from 1.0% to 5.1%, p = .044) and a reduction in azoospermia rate (from 9.8% to 7%, p = 0.044). Dividing the cohort in FSH-responders and non-responders, in terms of pregnancy achieved, higher sperm concentrations (15.7 ± 26.6 vs. 22.2 ± 25.7 million/mL, p = 0.033) and progressive sperm motility (18.0 ± 18.2 vs. 27.3 ± 11.3, p = 0.044) were found in pregnancy group. Conclusion:Our experience suggests that FSH, empirically administered to men with idiopathic infertility, leads to pregnancy in one out of four patients and increases sperm concentration. Although the expected limits because of a real-world data study, the number of FSH-treated patients required to achieve one pregnancy seems to be lower in clinical setting if compared to previously published data.

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“…Recently, the International Committee for Monitoring Assisted Reproductive Technologies (ICMART) provided a new definition of hypogonadotropic hypogonadism that fits well with the male infertility status, namely, “Gonadal failure associated with reduced gametogenesis and reduced gonadal steroid production due to reduced gonadotropin production or action” [ 2 ]. Male idiopathic infertility is defined as the clinical condition in which spermatogenesis is altered without a known cause [ 3 , 4 , 5 ]. This condition should be considered distinct from unexplained male infertility, defined as infertility of unknown origin but with normal sperm parameters [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

Testosterone Serum Levels Are Related to Sperm DNA Fragmentation Index Reduction after FSH Administration in Males with Idiopathic Infertility

Lispi

Drakopoulos²,

Spaggiari

et al. 2022

Biomedicines

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Purpose: Although a robust physiological rationale supports follicle stimulating hormone (FSH) use in male idiopathic infertility, useful biomarkers to evaluate its efficacy are not available. Thus, the primary aim of the study was to evaluate if testosterone serum levels are related to sperm DNA fragmentation (sDF) index change after FSH administration. The secondary aim was to confirm sDF index validity as a biomarker of FSH administration effectiveness in male idiopathic infertility. Methods: A retrospective, post-hoc re-analysis was performed on prospectively collected raw data of clinical trials in which idiopathic infertile men were treated with FSH and both testosterone serum levels and sDF were reported. Results: Three trials were included, accounting for 251 patients. The comprehensive analysis confirmed FSH’s beneficial effect on spermatogenesis detected in each trial. Indeed, an overall significant sDF decrease (p < 0.001) of 20.2% of baseline value was detected. Although sDF resulted to be unrelated to testosterone serum levels at baseline, a significant correlation was highlighted after three months of FSH treatment (p = 0.002). Moreover, testosterone serum levels and patients’ age significantly correlated with sDF (p = 0.006). Dividing the cohort into responders/not responders to FSH treatment according to sDF change, the FSH effectiveness in terms of sDF improvement was related to testosterone and male age (p = 0.003). Conclusion: Exogenous FSH administration in male idiopathic infertility is efficient in reducing sDF basal levels by about 20%. In terms of sDF reduction, 59.2% of the patients treated were FSH-responders. After three months of FSH administration, a significant inverse correlation between sDF and testosterone was detected, suggesting an association between the FSH-administration-related sDF improvement and testosterone serum levels increase. These observations lead to the hypothesis that FSH may promote communications or interactions between Sertoli cells and Leydig cells.

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Real-world evidence analysis of the follicle-stimulating hormone use in male idiopathic infertility

Cited by 7 publications

References 68 publications

Which sperm parameter limits could really guide the clinical decision in assisted reproduction?

Which sperm parameter limits could really guide the clinical decision in assisted reproduction?

Follicle‐stimulating hormone effectiveness in male idiopathic infertility: What happens in daily practice?

Testosterone Serum Levels Are Related to Sperm DNA Fragmentation Index Reduction after FSH Administration in Males with Idiopathic Infertility

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