Male infertility is a common clinical condition, and the causes of male infertility may include environmental factors, lifestyle, psychological factors and physiological disorders. In recent years, humans have experienced a decline in sperm quantity and quality, and the incidence of male infertility has a tendency to increase. According to Wang Yixin’s statistics, among the causes of male infertility in China, the rates of idiopathic oligospermia and weak spermia were 10.57% and 7.70% during 1986-1991, and rose to 13.33% and 17.42% during 1992-1993, respectively. For idiopathic oligo- and hypospermia, empirical treatment is mostly used clinically, among which low-dose androgen supplementation remains a controversial research hotspot. 129 patients were studied using a multicenter, randomized, single-blind, placebo-controlled approach from October 2005 to April 2007, and we report the following.
Data and Methods
I. Inclusion and exclusion criteria
Inclusion criteria.
1, normal sexual function in cohabitation after marriage.
2, no contraception.
3, normal fertility by gynecological examination of the female partner.
4. routine semen examination according to the WHO Standard Examination and Diagnosis Manual for Infertile Couples, meeting the criteria for oligospermia (sperm density < 20×106/ml, sperm viability a+b< 50%).
5. negative anti-sperm antibodies.
6. normal or lower than normal fructose level in semen, but greater than 0.
Exclusion criteria.
1, unable to live together for a long time after marriage.
2, abnormal sexual function and inability to discharge semen into the vagina of the female partner.
3, presence of anatomical abnormalities of the penis that seriously impair erectile function.
4. abnormalities in any of the 5 reproductive hormones
5. abnormal semen liquefaction time.
6. varicose veins of the spermatozoa.
7. azoospermia.
8, any physical, mental or substance abuse induced health abnormality that may affect the patient’s ability to complete the test or prevent him/her from participating in the test; 9, taking anti-androgen drugs, androgens
10, taking any other study drug (including placebo) within 30 d prior to the visit
11, allergy to Antel or any study drug.
II. Trial protocol
The study is a multicenter, randomized, single-blind, placebo-controlled prospective study of patients with oligozoospermia due to various etiologies. Patients were enrolled and first underwent routine analysis of semen according to WHO semen laboratory testing procedures for gat screening. The 5 reproductive hormones were also examined. At the end of the 3-month treatment period, semen analysis was repeated with Gat’s test and gonadal 5 tests.
III. Efficacy indicators
including semen volume, sperm density, sperm vitality, sperm viability, sperm malformation rate, sperm fructose and blood testosterone.
IV. Statistical analysis
The data of this study were analyzed by t-test, ANOVA, t’ test and rank sum test using the statistical software CHISS2004.
Results
The data of 129 patients who finalized the study were statistically analyzed. There were no statistical differences in semen volume, sperm density, sperm motility, sperm viability, sperm malformation rate, sperm fructose and blood testosterone between 85 patients in the Antel group and 44 patients in the placebo group, compared to the pre-treatment baseline values, as shown in Table 1.
At the end of the 3-month treatment, there was no statistical difference in any of these indicators between the placebo group patients after treatment and before treatment.
At the end of 3 months of treatment, patients in the Antel group had elevated semen volume after treatment compared to before treatment.