Assessment of Quality of Life During Gonadotrophin Treatment for Male Hypogonadotrophic Hypogonadism

Koji Shiraishi; Shintaro Okal Hideyasu Matsuyama


Clin Endocrinol. 2014;81(2):259-265. 

In This Article

Materials and Methods

Forty-one MHH patients who visited the andrology clinics of the UBE Central Hospital and Kuramoto Women's Clinic from October 2007 to July 2011 were asked to participate in this study. All of the participants provided written informed consent according to the study protocol, which was approved by the ethics committees of both the institutions. The chief complaints included the absence of puberty (n = 20, 49%), follow-up of panhypopituitarism (n = 11, 27%), atrophic changes of the genitalia (n = 7, 17%), ejaculation disorders (n = 2, 5%) and depressive symptoms (n = 1, 2%). Patients requiring infertility treatment were excluded from this study because there is a difference in the purpose of hormonal treatment, and therefore, the HRQOL scores of these patients would differ from those of other MHH patients. Diagnoses were made on the basis of a standard medical history, physical examination, plasma hormone assay and hCG stimulation test. Testicular volume was measured using a punched-out orchidometer, and the development of external genitalia was categorized by Tanner's classification. LH, FSH, oestradiol, prolactin and total testosterone levels were measured in the morning.

The SF-36 questionnaire[8] has been standardized for the Japanese culture by Fukuhara et al.[9] and has been widely applied as a general outcome measurement in healthy Japanese populations. The SF-36 consists of 36 items, including physical functioning (PF: ability to perform physical tasks; 10 questions), role-physical (RP: influence of physical health on work or other regular daily activities; four questions), bodily pain (BP: pain or limitations due to pain; two questions), general health (GH: self-evaluation of physical state; five questions), vitality (VT: vigour and energy level; four questions), social functioning (SF: ability to engage in social activity without pain; two questions), role-emotional (RE: influence of emotional on accomplishing tasks; three questions) and mental health (MH: self-evaluation of mental state; five questions). The results for each domain are calculated to yield an average score for each domain. Norm-based scores (NBS) were calculated according to the formula indicated in the Japanese version of the SF-36v2 Health Survey Scoring Algorithm; the Japanese average is 50, and the standard deviation is 10. Patients were asked to complete the SF-36 questionnaire before hormonal therapy and every 6 months before and after gonadotrophin or testosterone treatment.

The gonadotrophin treatment protocol followed the established protocol with modifications.[1–3] In brief, treatment began with subcutaneous self-administration of hCG for 6 months, followed by 75 IU rhFSH three times per week. After the 2-year study protocol, subsequent treatment was initiated or continued, depending on the patients' requirements. The patients were asked to perform semen examinations before the treatment, after 9 months of treatment and once treatment was complete. If sperm were visualized in azoospermic patients or if more than 10 million sperms were observed in cases of prior cryptozoospermia (a small number of immotile sperm in the ejaculate), the cases were categorized as sperm-positive. Testosterone enanthate (250 mg) was intramuscularly injected every 3 weeks for patients who chose testosterone treatment.

Differences in each SF-36 scale between the pretreatment and post-treatment values were analysed using a paired t-test. Differences between the changes in each domain and in clinical parameters were analysed using the Mann–Whitney test. Pearson's correlation was performed to examine the relationships between the changes in each domain and clinical parameters. All of the tests were two-tailed, and a 5% significance level was used for statistical significance. The spss software package (SPSS Inc., Chicago, IL, USA), version 12·0, was used for data processing.