Induction of spermatogenesis in men with hypogonadotropic hypogonadism

Morris, Guy; Lloyd-Evans, Esther; Cahill, David J

doi:10.1007/s10815-020-02058-0

Cited by 4 publications

(2 citation statements)

References 13 publications

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“…Nonsignificant increases in assisted conception pregnancy rates were noted in men having a varicocelectomy compared to an embolisation (clinical pregnancy rate OR: 2.07; 95%CI: 0.92-4.65; P = 0.08) [24] . Meta-analyses, however, support varicocele repair in advance of assisted conception [25] .…”

Section: Hypogonadism In Men Leading To Infertilitymentioning

confidence: 99%

Hypogonadism: cardiometabolism and gonadal function in men

Noble,

Cahill

2023

Metab Target Organ Damage

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Hypogonadism is a relatively rare condition in men, which increases in frequency as men age, but also as they become less active and gain weight. In the past 20 years, developing knowledge on the relationship between hypogonadism and cardiovascular and cerebrovascular health and on aspects of metabolic health has become clearer. The relationship between hypogonadism and specific endocrine abnormalities of spermatogenesis is much longer established. Long- and short-term testosterone replacement therapies have well-recognised effects on cardiovascular and cerebrovascular health and on aspects of metabolic health. This leads to a sense of safety when it comes to considering these options as ways of managing the recognised symptoms of hypogonadism and the hidden adverse findings. That confidence has yet to be proven by long-term randomised controlled studies. The use of exogenous gonadotrophins to raise endogenous testosterone levels is a cost-efficient method of achieving spermatogenesis but is not suitable for long-term testosterone maintenance therapy.

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Section: Hypogonadism In Men Leading To Infertilitymentioning

confidence: 99%

Hypogonadism: cardiometabolism and gonadal function in men

Noble,

Cahill

2023

Metab Target Organ Damage

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“… 14 Like FSH and LH, cost varies substantially, with 1 study reporting a monthly cost of$359 while pharmacies within our study reported monthly costs of less than$75 USD per month. 15 …”

Section: Introductionmentioning

confidence: 99%

The availability of gonadotropin therapy from FDA-approved pharmacies for men with hypogonadism and infertility

et al. 2023

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Background Recent changes to the Biologics Price Competition and Innovation Act of 2009 have created barriers to accessing therapy for men utilizing gonadotropins for hypogonadism and infertility. Aim In this study we sought to investigate ways to decrease disparities in the treatment of male hypogonadism by increasing access to gonadotropin therapy by identifying 503b outsourcing pharmacies which currently provide gonadotropin therapy. Methods A review of 503b compounding pharmacies was performed using the online published registry available from the US Food and Drug Administration (FDA). Each pharmacy was contacted regarding their ability to provide gonadotropin therapy. Pharmacies were also queried regarding the impact of FDA-related legal changes and cost considerations. Outcomes The study outcomes were the number and location of FDA-approved 503b compounding pharmacies supplying human chorionic gonadotrophin (hCG) and/or follicle-stimulating hormone (FSH) for the treatment of male hypogonadism and infertility. Results The 81 503b-compounding pharmacies approved by the FDA to produce hCG and FSH therapy were identified using the FDA registry. Seventy-five of the 81 pharmacies responded to the survey (response rate 92.6%). Of the contacted pharmacies, 5 provided hCG (6.67%). Of the pharmacies offering compounded hCG, 4 offered FSH. No additional pharmacies offered compounded FSH. Eight pharmacies had previously provided hCG and FSH. Six of the 8 pharmacies that stopped making hCG and FSH cited the 2020 FDA mandate as the reason for halting compounding services. Of the 75 pharmacies that responded, only 1 pharmacy provided the cost for FSH ($287 per 100-IU vial), and 3 pharmacies provided the cost for hCG ($50-$83 per 10 000-IU vial). Clinical Implications There are few FDA-approved outsourcing pharmacies currently providing male gonadotropin therapy, and increasing awareness of these pharmacies may decrease barriers to care for patients with male hypogonadism and infertility. Strengths and Limitations The strengths of this article are the clinical utility of the data presented, as this article may serve as a tool for clinicians to increase patient access to therapy. All FDA-approved 503b outsourcing pharmacies were contacted, and 92.6% participated in this project. Limitations of this article were the following: no non-FDA–approved compounding pharmacies such as 503a pharmacies were contacted, participant-reported outcomes were utilized, and only 3 contacted outsourcing pharmacies provided a cost for FSH or hCG, allowing for an unknown degree of cost variability between outsourcing pharmacies. Conclusions There currently exists limited access to FDA-approved compounded gonadotropin therapies for hypogonadism and male infertility, and these results demonstrate the barriers to hCG and FSH access and the need for additional treatment options for this vulnerable patient population.

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