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Asian Journal of Andrology. 1999 Jun; 1:7-12.The aim was to present a personal account of the involvement of the World Health Organization (WHO) in the collaborative development in Asia of those areas of andrology concerned with male contraception and reproductive health. The andrology training through workshops and institution support undertaken by the WHO Human Reproduction Programme (HRP) and how they contributed to the strengthening of andrology research in Asia are summarised. The author's experience and the Asian scientific contributions to the global research in the following areas are reviewed: the safety of vasectomy and the development of new methods of vas occlusion; gossypol and its failure to become a safe, reversible male antifertility drug; Tripterygium and whether its pure extracts will pass through the appropriate toxicology and phased clinical studies to become acceptable contraceptive drugs; hormonal methods of contraception for men. The WHO policy of research capacity building through training and institution strengthening, together with the collaboration of Asian andrologists, has created strong National institutions now able to direct their own programmes of research in clinical and scientific andrology. (author's)
CONTRACEPTION. 1980 Feb; 21(2):121-34.A 7-country WHO (World Health Organization) field trial on hormonal drugs for males administered either by daily pill or monthly injection, is being undertaken. The trials, being conducted in Hong Kong, Bangkok, London, Mexico City, Santiago, Seoul, and Toronto, provide an opportunity to assess acceptability and effects on sexuality of these new male contraceptives. The research uses repeated interviews over a 15-month period, conducted by social and biomedical scientists. The respondents are asked to compare their evaluation of the method with previously-used male or female methods and to indicate whether they feel the method modified or interfered with sexual desire, feelings, and/or performance. Methodology of the trials is explained. The hormones used, numbers of volunteers participating, and other factors important for each trial site are tabulated. Preliminary results are available from some of the trial sites The new method, either pill or injectable, was ranked highest as to acceptability, followed by vasectomy and condoms. Respondents favored self-administered, reversible methods. In fact, irreversibility was found to be the most negative feature of vasectomy, indicating that a reversible form of sterilization would be acceptable. Respondents in all trial sites favored 3-month injectables the most and permanent methods the least. Effectiveness and ease of use were important in a contraceptive.
Lancet. 1996 Mar 23; 347(9004):830-1.The authors explain that Bonn's science and medicine report fails to do justice to recent advances in the search for effective, reversible contraceptive methods for men. Bonn refers to two World Health Organization sponsored clinical studies which established the contraceptive efficacy of hormone-induced azoospermia and severe oligozoospermia, and provided indirect information upon the characteristics and potential acceptability of such methods. Contrary to her supposition, there was no empirical evidence that the nine men in the first study who stopped taking testosterone injections before the full year of contraceptive efficacy did so due to increased aggressiveness. The potential for supraphysiological concentrations of testosterone to induce behavior or mood changes is, however, a genuine concern which needs to be addressed appropriately. Behavioral issues and acceptability to both partners are an important aspect of research into hormonal methods of male fertility regulation. The authors note that although currently available options for men are extremely limited, research into contraception for men is sadly underfunded and underresearched.
In: Annual technical report, 1992, [of the] World Health Organization [WHO]. Special Programme of Research, Development and Research Training in Human Reproduction. Geneva, Switzerland, WHO, 1993. 63-78. (WHO/HRP/ATR/92/93)This document contains the 1992 Annual Report of the Task Force on [the development of safe, effective, reversible, and acceptable] Methods for the Regulation of Male Fertility of the World Health Organization's Special Programme of Research, Development, and Research Training in Human Reproduction. In the area of hormonal methods, the Task Force is currently concentrating its research activities on 1) the evaluation of the functional capacity of sperm produced by men who have been suppressed to severe oligozoospermia, 2) the development of testosterone buciclate as an injectable method and as replacement therapy for hypogonadal men, and 3) the development of second generation progestogens and new gonadotrophin-releasing hormone antagonists as gonadotrophin suppressing agents. The safety and acceptability of hormonal methods for men remain a concern and topic of research activities. As an alternative to hormonal methods, the Task Force is continuing its search for a drug with a reversible, post-testicular action on the normal function of sperm stored in the epididymis. An ideal preparation would be quickly effective and quickly reversible. Collaborative studies in China also continue to investigate the antifertility action of pure compounds isolated from the plant species Tripterygium wilfordii. During 1992, the Task Force also continued its support of studies on three methods of vas occlusion: the no-scalpel method, a chemical sterilization method, and the polyurethane-plug. The efficacy and reversibility of silicone vas occlusion also remains under study. A training workshop on vas occlusion methods was attended by 32 participants in Indonesia in April 1992, and the safety of vasectomy continues to be monitored by the Task Force. This report notes the state of research on inhibin isolated from porcine follicular fluid and on the possibility of an immunization approach based on a vaccine against follicle-stimulating hormone. Two projects supported in 1992 sought to identify sperm surface proteins as putative immunogens. The report ends by recounting its investigator initiatives, its collaborative research programs, and its efforts in the area of information distribution. A summary describes 10 areas in which substantial progress was made during 1992.
PROGRESS IN HUMAN REPRODUCTION RESEARCH. 1995; (33):2.Research results by the UNDP/UNFPA/WHO/World Bank Special Program in Human Reproduction published in 1990 showed that hormones can be used to reduce men's sperm levels to virtual infertility. Weekly injections of testosterone enanthate (TE) produced azoospermia in most men. A multicenter study was also completed in 1994 involving a total 399 men in nine countries who were given regular injections of TE. High contraceptive effectiveness resulted among those men whose sperm concentrations were reduced to 3 million or less per ml (oligozoospermia). The failure rate was 1.4 pregnancies per 100 person-years, similar to that of oral contraceptives. It took an average of 68 days to reach oligozoospermic and 100 days to reach azoospermic sperm counts after the 1st injection. To return to normal levels after the last injection took 112 days and 203 days, respectively, in oligozoospermic and azoospermic men. Testing of testosterone buciclate (TB) was also carried out in Germany to assess the effect of longer-acting androgen esters suppressing gonadotrophin secretion. Azoospermia was achieved in some men by giving a single dose of 1200 mg of TB, but at half that dose oligozoospermia was not reached. Research is also continuing into the male contraceptive effect of progestogen-androgen combinations. Progestogen prevents the production of sperm at much lower doses than androgen. Androgen is given to replace testosterone that is inhibited as a result of the suppression of gonadotrophin, but it is needed less frequently. The combination seems to suppress sperm production more quickly than the androgen alone. In China, India, and Indonesia, plans are prepared for efficacy studies with such combinations. The drawback for large-scale use is that the components have to be injected at different intervals. This may be overcome by combining TB with a progestogen with the same duration of action and giving both at the same time.
REPRODUCTION AND CONTRACEPTION. 1990 May; 10(2):6-9.Contraceptive research is a time-consuming and expensive endeavor. It takes 15 to 25 years and 15 million US dollars to develop a new contraceptive method. Such an expensive investment made it inhibitive for developing countries to have their own contraceptive research. Most of them have to use foreign currency to import contraceptives. Besides a few pharmaceutical companies, there are 7 important organizations and agencies in the world that are engaged in sponsoring or organizing contraceptive research. Among these organizations, WHO/HRP and UNFPA have had more involvement in contraceptive research in China. The emphasis of funding from HRP in recent years has switched from supporting organizational building of research institutes to finding specific research projects. HRP has 10 task forces which reviews research proposals from over the world and funding is provided to the projects approved. UNFPA has allocated 4.5 million US dollars in contraceptive research in its 1990-1994 assistance programs to China. 3 important issues that need basic research are 1. male contraceptives 2. male infertility and 3. mechanism of female menstrual disturbance. In the past number of years, international organizations have placed great emphasis on social and behavior research related to contraceptive practice. Attention has also been given to the development of management skills in the research institutes so that the scarce resources could be used efficiently. Training of personnel has also been a major component of assistance from both HRP and UNFPA. It has been suggested that a training center be established in China to serve the need of China and Asia and Pacific region.
MEDICAL JOURNAL OF AUSTRALIA. 1991 Feb 18; 154(4):230-3.The 1st published study of efficacy of a hormonal male contraceptive, by the WHO Special Programme of Research, Development and Research Training in Human Reproduction, employed weekly deep intramuscular injections of testosterone enanthate. 271 fertile married men at 10 centers worldwide participated for 18 months. The goal of this preliminary study was to determine if azoospermia was necessary or sufficient for effective contraception. Azoospermia was produced in 157 men, who then participated in a 12-month trial. There was 1 pregnancy, for a failure rate of 0.8 per 100 person-years, highly effective in comparison with oral contraceptives, IUDs and injectables. There was a 12% annual discontinuation rate reasons cited were acne (4%), behavioral effects such as aggression or increased libido (1%), and other medical reasons (1%), e.g. weight gain, polycythemia, hyperlipidemia or hypertension. Recruitment of study subjects was difficult in developed countries until direct public appeals met with success. Future developments in the male hormonal contraceptive field will require a more acceptable administration route. To develop this, longer-acting injectables or implants utilizing testosterone cybutanate (20AET-1), or other combinations of testosterone with a progestin or a gonadotropin-releasing hormone antagonist are envisioned. The effect of incomplete azoospermia and the fertilizing capacity of remaining sperm is a serious issue for research. Each more crucial is resolution of the social, political and legal problems involved in male hormonal contraceptive research. Probably reform of the US product liability litigation procedures will do more to advance contraceptive development than any other single factor.
PROGRESS. 1988; (5):1, 6.Despite more than a decade of intense research effort, no acceptable antifertility drug for men has been produced. No drug regimen has been able to completely suppress sperm in the ejaculate, and some men who have achieved azoospermia show a spontaneous return of sperm in the ejaculate. On the other hand, there is some evidence that the residual sperm produced by men whose sperm production is only partially suppressed are incapable of fertilizing ova. Preliminary results of research conducted by the World Health Organization's Special Program of Research, Development, and Research Training in Hum Reproduction indicate that an androgenic steroid administered in 200-mg doses at 21-day intervals induces azoospermia in 65% of male volunteers, moderately low levels of sperm in 11%, and severely low levels of sperm in 24%. Also encouraging is the finding that residual sperm in men who reach severely low levels of sperm production after treatment with depot-medroxyprogesterone acetate plus testosterone enanthate are functionally impaired when tested in the hamster oocyte penetration assay. If such results can be produced in field trials, the development of new, more effective drugs for the regulation of male fertility may be forthcoming. At the same time, a considerable amount of research remains to be done before a male fertility regulating pill will be available on the market.
Geneva, Switzerland, WHO, 1985 Dec. ix, 219 p.In response to mandates of the 1984 International Conference on Population, WHO's Special Program of Research, Development, and Research Training in Human Reproduction has established new Task Forces, strengthened the research capabilities of institutions in developing countries, intensified research on steroidal contraception, expanded attention to the social determinants and consequences of fertility, and increased collaboration with other major international programs engaged in research in human reproduction. The bulk of this annual report includes a technical review of the activities and plans of the Program's 9 Task Forces: Tasks Force on Long-Acting Systemic Agents; Task Force on Postovulatory Methods; Task Force on Vaccines; Task Force on Plants; Task Force on Male Methods; Task Force on Infertility; Task Force on Safety and Efficacy; Task Force on Behavioral and Social Determinants of Fertility; and work in the strengthening of research resources. Each Task Force report is presented in 4 major sections: the field of interest, comprising a brief review of the relevant technical subjects; the strategic plan, explaining how work is structured and scheduled; collaboration with other programs; and activities of the Task Force through the end of 1985. Also included in this report are sections on resources for research and management and financial matters. A Committee on Resources for Research has just been formed to review strategies for strengthening research resources in developing countries.
Association for Voluntary Sterilization - Consultant Team. Trip report: the People's Republic of China, Beijing, Chongqing, Wuhan, Guangzhou, June 19-30, 1985.
[Unpublished] 1985. 41,  p.The Association for Voluntary Sterilization consultant team visited Beijing, Chongqing, Wuhan and Guangzhou, China in June 1985, to review innovative nonsurgical methods of male and female sterilization. There are 2 variations on vasectomy, performed with special clamps that obviate a surgical incision. The 1st is a circular clamp for grasping the vas through the skin, and the 2nd is a small, curved, sharp hemostat for puncturing the skin and the vas sheath, used for ligation. Vas occlusion with 0.02 ml of a solution of phenol and cyanoacrylate has been performed on 500,000 men since 1972. The procedure is done under local anesthesia, and is controlled by injecting red and blue dye on contralateral sides. If urine is not brown, vasectomy by ligature is performed. The wound is closed with gauze only. Semen analysis is not done, but patients are advised to use contraception for the 1st 10 ejaculations. Pregnancy rates after vasectomy by percutaneous injection were reported as 0 in 5 groups of several hundred men each, 11.4% in 1 group and 2.4% in another group. The total complication rate after vasectomy by clamping was 1.8% in 121,000 men. 422 medical school graduates with surgical training have been certified in this vasectomy method. Chinese men are pleased with this method because it avoids surgery by knife, and asepsis, anesthesia and counseling are excellent. Female sterilization by blind transcervical delivery of a phenol-quinacrine mixture has been done on 200,000 women since 1970 by research teams in Guangzhou and Shanghai. A metal cannula is inserted into the tubal opening, tested for position by an injection of saline, and 0.1-0.12 ml of sclerosing solution is instilled. Correct placement is verified by x-ray, an IUD is inserted, and after 3 months a repeat hysteroscopy is done to test uterine pressure. Pregnancy rates have been 1-2.5%, generally in the 1st 2 years. Although this technique is tedious, requiring great skill and patient cooperation, it can be mastered by paramedicals. The WHO is assisting the Chinese on setting up large studies on safety and effectiveness, as well as toxicology studies needed, to export the methods to other countries.
Potential long-acting contraceptive agents: esters and ethers of testosterone with alpha- and/or beta-chain branching.
STEROIDS. 1985 Dec; 46(6):947-53.A chemical synthesis program was established by the World Health Organization in 1975 with the primary goal of identifying long-acting male and female steroidal contraceptive agents. During the period 1977-80, 3 participating laboratories synthesized 12 related potential long-acting male contraceptive steroid esters, all derivatives of testosterone. 2 of the compounds were alpha-monosubstituted esters, 6 were alpha, alpha'-disubstituted esters, and 1 was a beta,beta'-disubstituted ester. Another 1 was a ditestosterone ester that was both alpha-monosubstituted and alpha, alpha'-disubstituted. 2 siloxy esters of testosterone were included for comparison given their similar alkyl substitution patterns. Testosterone 2-methyl propanate was prepared through use of the conventional method of reacting 2-methyl propanol chloride with testosterone in the presence of pyridine. For the esterification of the 17-OH group in testosterone with 3,3-dimethyl butanoic and 2-ethyl butanoic acids, the benzenesulfonyl chloride method was employed. This article sets forth the analytical, physical, and spectroscopic data for all the compounds synthesized and submitted for bioassay.
Bulletin of the World Health Organization. 1978; 56(3):343-52.The WHO Special Programme of Research, Development and Research Training in Human Reproduction has established a 6-center program to investigate new fertility regulating agents from plants for use in humans. Establishment of the project was preceded by a comprehensive search of the literature, including the following sources: 1) articles on medical botany; 2) reports of testing crude plant extracts for fertility regulating purposes; 3) reports of in vitro effects of plant extracts; and 4) reports of a limited number of experimental studies in human subjects. The limitations of these sources of data are discussed. Information on 3000 plants was collected and computerized, using a weighting system, in order to assign priorities on the plant substances most promising for further study. The 6 centers will then procede to initiate pharmacological and chemical studies on the priority substances. Both male and female antifertility agents are included in the study. (Summary in FRE)
SCIENCE. 1980 Aug 29; 209(4460):992-4.WHO (World Health Organization) has sponsored a multinational cooperative research project in drug chemical synthesis outside the established pharmaceutical company channels. It is a model of particular relevance to developing countries and 1 that could be followed for development of drugs and pesticides. This particular program was launched because the pharmaceutical companies in developed countries were not interested in developing contraceptives that would be applicable for developing areas. The WHO-sponsored program involved synthesis of novel steroid compounds and thorough biological evaluation of the new substances. Approximately 220 steroids were synthesized in 12 laboratories in both developed and developing countries. The administrative and supervisory system of the program is explained. Quality control of the synthesized compounds took place at City University, London, and bioassay at the National Institute of Child health and Human Development in Bethesda, Maryland. The bioassay to determine the duration of long-acting progestogens was the suppression of estrus in rats. The test for androgenic activity was carried out in castrated male rats. Work on potential male contraceptives is being discontinued for financial reasons. However, 6 compounds of possible use in female contraception have been selected for further work.
American Pharmacy. 1979 Sep; 19(10):23-4.Pharmaceutical scientists and botanists from all over the world met at the University of Illinois to map a 3-year program for collecting and testing plants which may be effective in regulating fertility. Launched in July, 1979, the project will continue through May, 1982. The study is sponsored by the World Health Organization. More than 100 pounds of each plant sample are needed for the pharmacological and phytochemical tests. 300 plant species will be studied, which represents only a fraction of the almost 4000 species for which fertility-regulating information has been gathered. In 1974 Americans paid about $3 billion for prescriptions of plant-extracted drugs. In the same year the pharmaceutical companies devoted only $200,000 of a $1 million research effort to the study of plant extracts. The plant data are being analyzed and stored with the help of a computer system developed at the Illinois College of Pharmacy. The Natural Products Alert (NAPRALERT) system considers whether or not a plant is poisonous or has adverse side effects. An estimated 5000 scientific periodicals are computerized per year. Some 4000 plants are listed, but another 4000 with fertility regulation potential are expected to be recorded. Some 750,000 species of flowering plants grow on earth.
International Journal of Andrology. 1978 Oct; (1):93-101.In 1974, the year for which the most complete data are available, only 11% of the $60.6 million in international expenditures for reproductive research was allocated specifically to the male. 38% was designated for females; 39% was designated for both sexes. Funds for male-related research were allocated primarily (75%) for opportunity development (preclinical laboratory evaluation of possible new aproaches for fertility control). 12% each were spent on product development and on studies of effects of available methods. 1% was allocated for research professionals in the male research field. Money for male reproductive research was used in the United States (86%), with 12% going to other industrialized countries, and 1% to developing countries. 68% of U.S. funds came from the U.S.; 30% from industrialized countries; 1% from developing nations. The major supporter of each group was the government. 61% of U.S. funds were from government; the rest was equally divided between private foundations and pharmaceutical companies. In other industrialized nations, government spending was even greater. In 1975, the preponderance of male research money was spent for new opportunities by WHO (80%) and by U.S. government agencies (71%). Less was spent on product development by most agencies, except for the Population Council which allocated 55% for development research.
British Medical Bulletin. 1979 May; 35(2):199-204.Contraceptive research and development is primarily performed at universities and research councils due to the cost and time involved for industry and philanthropic organizations to bring drugs to market. Promising fundamental research includes immunization of women against chorionic gonadotrophin in order to disrupt the embryo in early pregnancy. Post-coital drugs, such as Anordrin, are also being developed for situations involving low-coital frequency. Once-a-month formulas are being developed to 1) exert a direct luteolytic effect on the corpus luteum; 2) interfere with the luteotrophic action of the implanting blastocyst; 3) inhibit the progestational development of the endometrium during the luteal phase of the cycle; or 4) exert a specific toxic effect on the early embryo. Methods for detecting ovulation incuding urine and saliva tests as well as electronic devices to measure the blood flow or temperature associated with ovulation are also being explored. Reversible fertility control for men which suppress the pituitary function is under investigation. Applied research includes the design and assessment of alternate delivery systems such as intranasal sprays, intracervical devices, paper pills, vaginal rings, and biodegradable subdermal implants. In addition, long-acting injectable progestins, improved IUDs, and improved sterilization techniques are all being tested. With future funds, the comparative safety, efficacy, and acceptability of various fertility methods can be established.
Evaluation of the work of the Task Force on Indigenous Plants for Fertility Regulation of the Special Programme of Research in Human Reproduction.
In: Assessment of the WHO Special Programme of Research, Development and Research Training in Human Reproduction [HRP]. II. Task Force reports. Country reports, [compiled by] Sweden. Swedish Agency for Research Cooperation with Developing Countries [SAREC]. Stockholm, Sweden, SAREC, 1983 Apr.  p..This report describes and evaluates the work of the Task Force on Indigenous Plants for Fertility Regulation of the Special Programme of Research in Human Reproduction at WHO. The goal of the project is to set up a network of collaborating centers to train personnel, design bioassays, isolate and test plant substances that are safe and effective by oral route for "morning after" pills or anti-implantation agents or male contraceptives. Plants chosen for assay were selected by a literature search including ethnomedical sources. All data were computerized, weighted and rank ordered. 300 of the 4500 species fell into the high priority group. 4 research centers now participate: Chinese University of Hong Kong, Seoul National University, University of Peradeniya, Sri Lanka and University of Illinois. In 1980-1981 the literature surveillance component of the Task Force provided bi-annual literature updates on the assigned plants. Primate studies are planned for 1982 and phase I human trials are anticipated in 1985 for the 1st compound. Zoapatle (Montanoa tomentosa) is a plant used for centuries in Mexico to terminate early pregnancy. An active compound, zoapatanol, and another more stable analogue are in pre-phase I trials. 4 plants from India are being examined for sperm agglutination activity, the spermatogenesis inhibiting effect of Koenchai (Chinese celery) and the mechanism of action of gossypol are being researched.