Industrial aspects of abdominal trauma.
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Biomedical subjects
Publications and source records attributed to D Marmor.
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The testicular function of 47 men who had been treated by MOPP chemotherapy for a Hodgkin's disease was studied in a long-term survey. Azoospermia was constant during at least 14 months after completion of the treatment. After a follow-up period of 89.4 +/- 54.7 months, 26 men were still azoospermic. No correlation could be found between the therapeutic regimen and the results of semen analysis. For the same treatment, some men recovered spermatogenesis within 5 years, others after more than 10 years while some were still azoospermic after 20 years. However, the association of infra-diaphragmatic irradiation to high dose MOPP therapy had a profound detrimental effect on spermatogenesis: only 3/13 men recovered. Sperm recovery was often incomplete: 17/21 men had a sperm count below 20 million ml-1. Yet, spontaneous pregnancies were obtained with severe oligozoospermia: only 1/11 sperm counts performed close to fertilization exceeded 20 million ml-1, and 8 were below 5 millions ml-1. FSH failed to be either a sensitive or a specific marker of sperm recovery, a discrepancy between FSH level and spermiogram being noticed in 18.2% of cases.
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The carrying out of clinical trials with a view to the marketing of drugs for human use is directly related to results of some animal studies. This workshop was devoted to evaluation of the quality and interest of these experimental models in reproductive toxicology. The predictive ability of preclinical trials to make extrapolations from animals to man decreases from foetotoxic to tetratogenic risks respectively and from the effects on fertility in both sexes to postnatal risks. As a result of this workshop, we propose the following improvements: (1) standardization and generalization of fertility test evaluations, especially the spermogram, in order to improve animal and human correlations; (2) development of knowledge and standardization of the follow up of the oestral cycle; (3) improvement of standardization, harmonization and diffusion of postnatal tests that prove relevant in animals; (4) increase in initiatives aimed at better mutual understanding of all drug partners; (5) creation of registers for new drugs, as soon as possible during clinical trials, to study their effects on the whole reproductive process; (6) recommendations for the creation of guidelines for International Conference on Harmonisation (ICH) to enable classification of observed effects in experimental models. This could lead to specific (potentially for each phase of the reproductive cycle) guidelines, precautions for use and/or contraindications which are listed in the summary of product characteristics.