Infertility is a world wide problem affecting up to 5% of all couples and in some communities up to 30% (WHO, l975). Although it is well known that the male factor is the main cause of the infertility in 40-50% of the cases, the appropriate drugs for treating this condition have not yet been found. Androgens have been tried at different doses, the higher ones to provoke suppression of spermatogenesis and ultimate rebound phenomenon. This has led to controversy due to the high percentage of permanent oligozoospermia reported by some authors (2-8%) and to the short-lived improvement obtained with this treatment. Mesterolone, an androgen without suppressive action upon the hypothalmic-pituitary axis. is presently used, although results are not yet conclusive.
The present investigation would assess the effectiveness of mestero1one currently used in the treatment of idiopathic male infertility. To assess the effectiveness of treatment with mesterolone which is alleged to improve semen quality (sperm density, motility and morphology) in idiopathic infertile selected patients, this would be a double blind study to follow prospectively men suffering from primary idiopathic testicular failure being treated with mesterolone, Proviron, Schering, a drug which is presumed to improve this condition. Results would be assessed through several sperm parameters and pregnancy rate. Participants in the study will be men with primary idiopathic oligozoospermia and asthenozoospermia. The inclusion criteria would be as follows: a) men aged 20-40 years, whose female partners are entirely normal, b) informed volunteers with primary testicular failure, c) men having vaginal intercourse at least 2 times weekly with one partner and without known psycho-sexual problems, d) men willing to enter this study and relying only on the drug administered throughout the study, e) no history of renal, liver or any other chronic physical or psychological disease, t men who can be followed up regularly, and g) men whose female partner is not using any method of family planning. The exclusion criteria would be as follows: a) azoospermic patients, b) history of recent or severe liver or renal disease, and c) history recent severe infectious disease (less than 3 months ago), d) clinically detectable chronic diseases, e) concurrent use of drugs known or suspected to interact with the drug to be administered in the study or known to affect spermatogenesis.
A total of 90 subjects are divided into the fol1owing three groups: a) placebo group: consisted of 30 Korean male with 15 oligozoospermia with sperm count of less than 20 x 1,000,000/ml and 15 asthenozoospermia with sperm motility of less than 309b, b) oligozoospermia group: consisted of 30 patients with sperm counts of less than 20 x1,000,000/ml, and c) asthenozoospermia group: consisted of 30 patients with sperm motility of less than 30%.
Parameters for study are as follows: history taking, physical examination (testis size), laboratory works (CBC ESR, urinalysis, fructose in seminal fluid, testicular biopsy, semen analyses (pH of semen, volume, liquefaction. density, motility, agglutination, viability, normal form, WBC), hormonal assays (FSH, LH, testosterone, prolactin).
Before starting treatment, 2 semen samples will be obtained with a time interval of not less than 1 week, each preceded by 3 days of sexual abstinence. For follow-up, patients will have a semen sample taken every month each preceded by 3 days of sexual abstinence while in treatment. After treatment, and for 3 months, a monthly semen analysis will be undertaken.
Treatment scheme as follows: 75mg of mesterolone (proviron) was given by mouth daily for more than 90days to be justified on the basis of general assumption that spermatogenetic cycle lasts approximately 74days. An average duration of the treatment was 6.8 months in this study. In placebo group, digestive tablets are given as mesterolone administration.
Clinical characteristics of a total of 90 patients were listed in the table l. The results were considered to be effective (+), if more than 30%, of improvement being noted on the count or more than 20% of improvement being noted on motility beyond the pre-treatment level.
The results of this study are presented as follows: Changes of sperm density after treatment: Oligozoospermia group: sperm counts increased in 27%, of the 15 placebo treatment patients and 37% of the 30 mesterolone treatment patients. Asthenozoospermia group: sperm counts increased in 20%, of the 15 placebo treatment patients and in 27% of the 30 mesterolone treatment patients. Changes of sperm motility after treatment: Asthenozoospermia group: sperm motility improved in 13% of placebo treatment patients and 27% of mesterolone treatment patients. Oligozoospermia group: sperm motility improved in 20%, placebo treatment patients and 30% of mesterolone treatment patients. Changes of other parameters after treatment: Volume of seminal fluid and normal shape of spermatozoa were not changed significantly before and after the treatment between placebo and mesterolone groups and also between oligozoospermia and asthenozoospermia groups. Coital frequency and body weight were tend to increase after the mesterolone treatment. Pregnancy rates after treatment: Pregnancy resulted in l3%, of placebo treatment patients and 17% of mestero1one treatment patients in oligozoospermia group. Pregnancy occurred in 7%, of placebo treatment patients and l0% of mesterolone treatment patients in asthenozoospermia group. In conclusion, the author’s clinical experience confirmed that mesterolone appears to be of value particularly in the treatment of idiopathic oligozoospermia and asthenozoospermia without any noticeable adverse effects.
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