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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.
Geneva, World Health Organization, 1966. (Technical Report Series NO. 332).The value and possible hazards of IUDs are discussed. Grafenberg developed a metal ring IUD in 1928. There was initial enthusiasm about the device, but it became discredited and interest was not revived in the method until 1959. Today, various shapes, sizes, and materials are employed in making IUD'S. No single cause or mechanism of action of an IUD has so far come to light. In sub-human primates the IUD causes accelerated passage of ova through the tube and the rest of the reproductive tract appears to be the major, but not necessarily the only, mechanism, of action. In ruminants, the contraceptive action of the IUD is exerted, at least in part, at the ovarian level. In rats, mice, rabbits, and ferrets, the main effect of the IUD is suppression of the implantation. It is concluded that the action of the IUDs in the human species is exerted before the stage of implantation. The most effective devices are associated with an incidence of 1.8 to 2.9 pregnancies per 100 insertions during the first year of use. The frequency of spontaneous expulsion ranges from about 5% to over 20% depending on the type of device. About one half of all expulsions occur in the first 3 months and comparatively few after the first year. The incidence of removal for medical reasons ranges from approximately 10% to 25% of first insertions during the first year. The method can be used successfully by almost 3 out of every 4 women who adopt it. Side effect and complications include bleeding and pain and less frequently pelvic inflammatory disease and perforation. The only absolute contraindications to the use of IUDs are: (1) active pelvic inflammatory disease, and (2) pregnancy, proven or suspected. Research needs are noted.
WOMEN'S GLOBAL NETWORK FOR REPRODUCTIVE RIGHTS NEWSLETTER. 1994 Apr-Jun; (46):3-5.The director of the World Health Organization (WHO) Human Reproduction Programme (HRP) responded to a call for stopping research on antifertility vaccines, saying that his department was developing vaccines to provide a wider choice of contraceptives and that in the first trial with HRP's prototype immune contraceptive, a high level of efficacy was obtained, no adverse side effects were observed, and the vaccine was well accepted by the clinical trial volunteers. He claims the authors of the call have used alarmist speculation and technical and scientific distortions to support their opposition to the development of this new technology. Judith Richter reports the above response and then responds in return to Antifertility Vaccines: Current Status and Implication for Family Planning Programmes. HRP's aim is to develop antifertility vaccines with a duration of 12-18 months following one single injection or oral administration for 98% of the users. HRP's immune contraceptive is still far from meeting this goal. It is doubtful whether safe reversible immunological contraceptive methods will be accessible to those women most at risk of contraceptive abuse, who depend on family planning programmes for birth control. The costs to ensure an overall coverage of reversal procedures are also suspect. Once developed, antifertility vaccines will be beyond social control. Their abuse potential alone is reason enough to ask for a stop of the research. The issue may be less one of increasing the range of available contraceptives, but one of improving the range of available contraceptives. Population control ideology should not guide the development of contraceptives. The aim must be to enable women to exert greater control over their fertility without sacrificing their integrity, health, and well being.
REPRODUCTIVE HEALTH MATTERS. 1993 Nov; (2):125-6.In June 1993, scientists, clinicians, family planning specialists, officials of national drug regulatory agencies, and pharmaceutical industry representatives attended a World Health Organization [WHO] expert group meeting in Geneva to examine all available data from preclinical and clinical trials on the safety and efficacy of two once-a-month injectables containing both an estrogen and a progestogen (Cyclofem and Mesigyna). WHO's Special Programme of Research, Development and Research Training in Human Reproduction developed Cyclofem and Mesigyna. The two new preparations have much lower doses of estrogen and progestogen as well as a different type of progestogen than do the older preparations. The Programme decided on these two formulations because they completely suppress ovulation and have the least effect on menstrual patterns. 5 clinical trials sites examined 9793 women for 102,058 woman-months of use. Pregnancy rates were considerably less than 1%. Predictable regular cycles occurred in 65% of the women. The discontinuation rate for bleeding problems was less than 50% of that for progestogen-only injectables. Ovulation returned within 2-3 months after discontinuation. Pregnancy, suspicion of pregnancy, and breast feeding are contraindications of the two new formulations. Meeting participants recommended that clinicians provide potential users with adequate information and family planning advice, undergo training in the new methods, and follow appropriate distribution and storage procedures. They found the two preparations to be as effective as Depo-Provera and to cause good cycle control and few side effects. Thus, they gave their approval for the two methods to be added to the range of existing contraceptive options.
IPPF MEDICAL BULLETIN. 1993 Jun; 27(3):1-2.Sterilization consists of occlusion of the vas deferentia or the Fallopian tubes to prevent the sperm and ovum from joining. Counseling is important since voluntary surgical and contraception is a permanent contraceptive method. Trained counselors should know about and discuss other contraceptive methods, the types of anesthesia available, and the different sterilization procedures and stress the permanent nature of sterilization and the minimal risk of failure. Counseling must maintain voluntary, informed consent and not coerce anyone to undergo sterilization. It is best to counsel both partners. Vasectomy should be encouraged because it is simpler and safer than female sterilization. Most sterilization techniques are simple and safe, allowing physicians to conduct them on an outpatient basis. Local anesthesia and light sedation are the preferable means to reduce pain and anxiety. In cases where general anesthesia is required, the patient should fast for at least 6 hours beforehand and the health facility must have emergency resuscitation equipment and people trained in its use available. Aseptic conditions should b maintained at all times. Vasectomy is not effective until azoospermia has been achieved, usually after at least 15 ejaculations. The no-scalpel technique causes less surgical trauma, which should increase the acceptability of vasectomy. Vasectomy complications may be hematoma, local infection, orchitis, spermatic granuloma, and antisperm antibodies. Spontaneous recanalization of the vasa is extremely rare. Postpartum sterilization is simpler and more cost-effective than interval sterilization. Procedures through which physicians occlude the Fallopian tubes include minilaparotomy, laparoscopy, and vaginal sterilization via colpotomy or culdoscopy. They either ligate the Fallopian tubes or apply silastic rings or clip to them. Vaginal sterilization is the riskiest procedure. Reversal is more likely with clips. So complications from female sterilization are anesthetic accidents, wound infection, pelvic infection, and intraperitoneal hemorrhage. About 1% of all sterilization clients request reversal. Pregnancy rates are low with reversal.
INTERNATIONAL JOURNAL OF ANDROLOGY. 1992 Dec; 15(6):455-9.Bilateral vasectomy for contraceptive purposes is one of the most frequently performed minor operations; an estimated 50 million men have had it done to themselves. Vasectomy remains unacceptable in some countries, however, due to religion-imposed constraints or fear of side-effects or trauma. A 100% effective, reversible vasectomy without complications or side-effects would allay the fears of potential candidates for the procedure. To that end, the Male Task Force of the World Health Organization Special Program of Research, Development, and Research Training in Human Reproduction is supporting studies on reversible vasectomy. One-third of marriages in many developed countries end in separation, and many separated men tend to request a reversal of their vasectomies. The current least traumatic, effective vasectomy is the no-scalpel method developed in China. Minimal though it may be in terms of tissue disruption, this type of vasectomy is no less easy to reverse than any other surgical method. The practice of chemical vas occlusion using a carbolic acid-cyanoacrylate glue has potential, but is again no easier to reverse. Research has led to the consideration of whether an inert substance could be equally capable of plugging the vas, yet more easily reversible. Zhao et al, have successfully restored fertility in 130 men after removing polyurethane elastomer plugs 3-5 years after vasectomy. Efficacy studies are needed. The use of silicone plugs is also being evaluated. 9 months or more after insertion, however, may be required to secure azoospermia using either the polyurethane or silicone plugs. There may also be a prolonged period of leakage of viable spermatozoa around an inert plug which does not cause sclerosis. Finally, further study needs to be conducted to find the ideal size and shape of a silicone plug or plugs which may be used and whether secondary testicular or epididymal changes will make reversal difficult. It is pointed out, however, that secondary changes may take many years to develop and may not be relevant, since most reversals are requested within 5-10 years of vasectomy.
WASHINGTON MEMO. 1992 Nov 12; (17):2-3.In October 1992, the US Food and Drug Administration (FDA) approved Depo-Provera for contraceptive use thus increasing the number of available contraceptives to women. Yet USAID has distributed it through its family planning programs in developing countries for many years. It has been available in the US since 1969 for noncontraceptive purposes such as endometrial cancer treatment. More than >30 million women around the world have used it to prevent conception. Today about 9 million women in 90 countries use it. A reason FDA did not approve Depo-Provera is that some studies revealed a link between it and breast tumors and cervical cancer in animals. More recent research conducted by WHO shows no connection with cervical cancer or ovarian cancer. In fact, it demonstrates Depo-Provera may protect against endometrial cancer. Yet it does indicate an insignificant increased risk of breast cancer in younger women. Some research suggests Depo-Provera may decrease bone density leading to osteoporosis and may increase the risk of having a low birth weight infant if the child is conceived before an injection. Evidence exists that it may lead to longer delays in becoming pregnant than other forms of contraception. Still 70% do conceive within 12 months after the last injection. Each Depo-Provera injection delivers a progestin in a water-based solution over 12 weeks resulting in suppressed ovulation. Its failure rate is <.5%/year, so Depo-Provera is one of the most effective reversible contraceptive available. The most common side effects are menstrual changes and weight gain (5-15 lbs.). Some contraindications include pregnancy, heart or liver disease, and breast cancer. As of November 1992, the FDA had not announced the cost or whether there would be a reduced price for family planning and public health clinics. Women's health and rights advocates plan on monitoring introduction of Depo-Provera to make sure that women have received comprehensive information and were not coerced to use it.
NETWORK. 1992 Aug; 13(1):20-3.Researchers are pursuing 2 approaches to developing a male contraceptive drug. 1 approach centers around suppression of sperm production the other around blocking conception. Researchers are looking at introducing hormonal contraceptives into men's bodies via injections or implants to stop sperm production. Both forms of these possible male contraceptives will not be available for many years, however. A WHO study on testosterone enanthate of men in 7 countries reveals total suppression of sperm production occurred in almost all the Asian men, but only about 60% suppression occurred in other ethnic groups. A current WHO study is examining whether a hormonal contraceptive which is not 100% effective can be useful if it would be more effective than barrier methods. The Population Council is conducting research on 2 capsule implants with 1 capsule releasing luteinizing hormone releasing hormone 13 to halt sperm production while the other releases an androgen to maintain sex drive. Animal tests indicate complete contraception with no side effects. The other possible means of suppressing sperm production is administration of a cottonseed oil extract called gossypol which appears to stop sperm production thereby eliminating the need for concurrent androgen administration. Yet it does cause potassium depletion in some men which can result in arrhythmias. An antifertility vaccine comprises the 2nd approach. Several US researchers are exploring an antifertility vaccine to produce antibodies only to the specialized sperm surface needed to attach to the egg. The 1st antifertility vaccine would probably be in pill form and a woman's contraceptive since it is earlier to target the smaller number of sperm in the oviduct than in the testes.
CONTRACEPTION. 1992 Aug; 46(2):103-4.WHO formed its Task Force on Methods for the Regulation of Male Fertility in 1972. Its charge is developing safe, effective, reversible, and affordable contraceptive methods for developing countries. The research focus is on suppression of sperm production. The research strategy consists of 3 parts: suppression of secretion of the pituitary gonadotropin hormones, recouping circulating androgen to physiological levels without prompting spermatogenesis, and determining the functional ability of residual sperm if treatment does not bring about azoospermia in all cases. A task Force study reveals that men of various ethnic groups respond to testosterone contraceptives differently. Other clinical research involved an androgen with a progestogen such as DMPA. Since steroids are basically inexpensive to produce they may prove to be beneficial and affordable to national family planning programs in developing countries. Gonadotropin releasing hormone (GnRH) antagonists proved to be relatively effective in suppressing gonadotropins and sperm production in animals. Scientists working on developing GnRH antagonists should strive to formulate a reversible contraceptive with no side effects which requires limited injections. The Task Force carried out a study in bonnet monkeys with the GnRH agonist buserelin in which buserelin suppressed spermatogenesis for 3 years and, after treatment, testicular function was entirely restored. Subsequent mating trials indicated they were fertile. The Task Force planned to follow the study with a GnRH antagonist. The 1st international gathering on GnRH analogues in China served to bring together scientists the world over to meet and to collaborate in developing new drugs for contraceptive use.
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.
INDIAN JOURNAL OF EXPERIMENTAL BIOLOGY. 1988 Apr; 26(4):243-51.A comprehensive review of the immunobiology of human chorionic gonadotropin (hCG), including the structure of both alpha and beta chains, immunogenicity of various segments and epitopes of each, secretion and function of the hormone, determinants of receptor recognition, and finally, clinical studies of possible contraceptive beta-hCG-based vaccines, is presented. hCG is composed of 2 glycosylated peptides. The alpha subunit is identical to that found in hLH, hFSH and hTSH. The beta subunit, which is limiting in the sense that it is secreted in smaller amounts, defines the biological activity of hCG. hCG is secreted throughout pregnancy from 170 hours after fertilization to a peak at 8-10 weeks of and is essential for maintenance of early pregnancy by progesterone secreted by the corpus luteum. Although native hCG evokes antibodies, they cross react with LH, so such a vaccine would not be useful for contraception. Beta-hCG has been purified and also produced by monoclonal antibodies, and shown to produce antibodies and infertility in baboons. Phase I clinical trials of immunologically purified beta-hCG complexed to tetanus toxoid were conducted on 63 women in an international study in the mid-1970s, but results were mixed in terms of antibody titer and duration. New vaccines have been designed based on more sophisticated adjuvants, beta- hCG-terminal peptides, and polyvalent vaccines and are being tested in 4 Phase I trials currently, sponsored by the Population Council, the Indian government-sponsored program, and the WHO.
[Some facts concerning injectable contraceptives: memorandum of a World Health Organization meeting] Quelques faits concernant les contraceptifs injectables: memorandum sur une reunion de l'OMS.
Bulletin of the World Health Organization. 1982; 60(4):535-48.This memorandum seeks to clarify issues concerning the safety of injectable contraceptives and to recommend areas for further research. Depo-Provera and norethindrone enanthate, 2 long-acting progestagen preparations, offer the important advantages in contraception of high efficacy, prolonged effect, and reversibility. Depo-Provera has been used since 1950 to treat a wide variety of complaints without serious side effects. It is estimated to have been used by about 10 million women for contraception and is currently used by about 1.5 million in 84 countries. Norethindrone enanthate has been much less widely used since its appearance in 1966 and is currently available in 40 countries. The Group on Toxicologic Evaluation, reviewing the results of longterm use of the 2 steroids in mice, rats, and rhesus monkeys, found no reason to modify their earlier position that the 2 substances were sufficiently safe for use in contraceptive programs. The Group also concluded that beagle dogs are inappropriate models for observation of the effects of the 2 steroids in women because of the predisposition of beagles to mammary tumors and acromegaly and because of differences in the specificity of their progesterone receptors. Some of the dosage levels used in the beagle studies were also questioned. Results of a large number of trials on women in numerous countries were reviewed regarding consequences of the different pharmacological properties of the 2 preparations, their effectiveness at different dosage levels, the nature and consequences of bleeding problems, current knowledge concerning their effects on lipid and glucose metabolism and liver function, possible carcinogenic effects, return of fertility, and effects of exposure in utero or through the mother's milk. None of the clinical or epidemiological studies was able to demonstrate life-threatening secondary effects. The most frequent secondary effect is the disturbance of menstrual cycles which is observed in the majority of women and is the most common cause of discontinuation. Although no serious short or longterm effects have been noted, the substances have been in use for a relatively short time. Research should proceed on the effects of longterm use of both steroids on lipid and glucose metabolism, on the appearance of neoplasms, and on the later development of the fetus or nursing child exposed to them. The study group concluded that Depo-Provera and norethindrone enanthate are acceptable methods of fertility regulation.
[Voluntary sterilization in France and in the world] La sterilisation volontaire en France et dans le monde.
Paris, Masson, 1981. 277 p.This monograph, directed not only to medical and paramedical personnel but to sterilization seekers as well, touches upon all aspects of voluntary sexual sterilization. The history of sterilization is follwed by a review of female and male anatomy and physiology, and of present available and reversible methods of contraception. All surgical, laparoscopic, tubal, electrocoagulation, culdoscopic, or hysteroscopic methods of female sterilization are described, and results, including morbidity and mortality, complication rates, side effects, and failure rates are presented. This part of the monograph is illustrated with clear and schematic drawings. Problems related to demand for reversal of sterilization are discussed. The same is done for male sterilization, its techniques and complications. The monograph discusses the ever increasing demographic problem in the world , and the role and the extent of voluntary sexual sterilization in industrialized countries and in third world countries, stressing the efforts of those international agencies, such as WHO, IPPF, the Population Council, the European Council, UNFPA, and the World Federation of Associations for Voluntary Sterilization, which promote sterilization around the world, and offer sterilization services. The authors then investigate the role of the physician in the decision to recur to sterilization as a permanent contraceptive method, and in deciding the proper surgical technique. A special chapter discusses the psychological conflicts related to sterilization, especially those which arise before the intervention, and which may very well represent the strongest contraindication to sterilization. A final chapter is devoted to France and to the sociocultural aspects which make sterilization more or less acceptable, the existing legislation, and the professional problems linked to sterilization interventions.
Science. 1982 Jul 30; 217(4558):424-8.The record of the U.S. Food and Drug Administration's (USFDA) actions regarding Depo-Provera, a medroxyprogesterone acetate, as an injectable contraceptive and the international implications are reviewed. In September 1982 a special panel of scientists began deliberations to recommend whether Depo-Provera should be approved for use as an injectable contraceptive. The U.S. Agency for International Development (USAID) has been asked by developing countries to furnish the drug but will not export drugs that are not approved by USFDA. More than 80 countries have approved the drug. Advocates for USFDA approval include the Upjohn Company (manufacturer of the drug), World Health Organization, International Planned Parenthood Federation, Population Crisis Committee, and the American College of Obstetrics and Gynecology. The opposition includes the Health Research Group affiliated with Ralph Nader, the National Women's Health Network, and several right-to-life groups. Hesitation by USFDA is related to laboratory animal studies which suggest that Depo-Provera is a potential human carcinogen. Upjohn conducted a 7 year study with 16 beagles and a 10 year study with Rhesus monkeys; both of the test animals developed more tumors than the controls. Questions were raised about using the animals since the response of these two species to the drug and the human response are not necessarily comparable. Limited approval has been recommended twice by expert advisory committees in 1974 and 1975, but USFDA refused both times. It is suspected that Korea, Taiwan, Egypt, Jordan, and Yemen reversed their approval as a result of the latest USFDA rejection. This final decision will have major economic and social implications and will assume international importance.
In: Phillips JM, ed. Microsurgery in gynecology, 2. Downey, California, American Association of Gynecologic Laparoscopists, 1981. 224-6.AID's Office of Population has been providing voluntary sterilization through its programs in developing countries since 1965. The demand has grown over the years. However, there is also a growing demand for both female and male reversal procedures. Usually the reasons for a reversal request are divorce and remarriage or the death of a child. To meet this increased demand, the Office of Population is sponsoring a program of research, training, and service. A 1977 workshop on reversal of sterilization, sponsored by the AID-funded Program for Applied Research on Fertility Regulation, presented the results of ongoing research. Microsurgery was highlighted as the main tool for sterilization reversal programs. A training program in microsurgery reversal techniques is in operation at Johns Hopkins University. This program is training participants from developing countries and now has 12 trained individuals with the necessary skills and equipment to establish a national reversal center. Other researchers are investigating the possibility of using uterotubal-juncture blocking devices or removable, modified Hulka clips for sterilization to facilitate a potential reversal procedure. Since the number of sterilization procedures performed far outweighs that of reversals, ease and safety of the sterilization must be the main priority. Therefore, such experimental methods are of secondary interest. While sterilization at this time must be considered permanent, microsurgery techniques have achieved reversal success rates as high as 83% in females and 95% in males.
In: Zatuchni GI, Labbok MH, Sciarra JJ, eds. Research frontiers in fertility regulation. Hagerstown, Maryland, Harper and Row, 1980. 213-29. (PARFR Series on Fertility Regulation)The systems-engineering approach to delivery of long-term contraception can involve the use of matrix devices for contraceptive steroids from which the steroid is released at a controlled rate over a prolonged period of time after a single administration. The concept of system design principles in contraceptive delivery is explained. In 1973, WHO organized a task force on long-acting systemic agents for fertility regulation. This is the report on a WHO-sponsored project to incorporate the basic design principles of a long-acting system into the design of an injectable particulate contraceptive system. The initial requirements included: 1) provision by a single administration of continuous controlled release of NET (norethisterone) for at least 6 months; 2) injection-administered carrier; 3) biodegradable carrier; 4) no carrier-induced side effects at the site of the injections; 5) complete disappearance of all components from the injection site; 6) a flexible system as to dose and duration to accommodate individual needs; and 7) reversibility of treatment. Experimental data so far satisfy the 1st 6 requirements. The injectable particulate system cannot be made reversible. Aspects for future research in this area are mentioned.
Family Coordinator. 1973 Jul; 22(3):331-8.Data collected on behalf of the Planned Parenthood/World Population (PPWP) affiliate to be used in planning a vasectomy education program came from a survey of 387 men and women in Hayward, California, to ascertain the levels of knowledge and prevalence of vasectomy and attitudes toward the operation. The sample was comprised of men and women in 3 income categories, and households were not preselected on a random basis. The survey instrument was a 1-page set of questions, primarily of the closed-ended type which the respondent completed in the presence of the interviewer. The major findings were: 1) PPWP was not identified as a source of aid; 2) most men and women have discussed vasectomy with their spouses; 3) men and women are influenced by attitudes and practices of others with regard to vasectomy; 4) physicians are seen as the main source of information about vasectomy; 5) irreversibility is the major concern of the men and women; and 6) eligible couples can be reached only by a community-side education program. Implications of the survey for a community education program are put into concrete, programmatic terms, indicating lines of direction, points of departure, and crucial ideas sometimes overlooked in service programs. It is concluded that in all areas of a community education program vasectomy should be presented as 1 or a range of alternatives, thus assuring the couple that does elect vasectomy that they really did make a free choice.
In: Diczfalusy, E., ed. Regulation of human fertility. (Proceedings of the WHO Symposium on Advances in Fertility Regulation, Moscow, USSR, November 16-19, 1976) Copenhagen, Denmark, Scriptor, 1977. p. 283-321This review of low-dose gestagen contraception emphasizes the variety of findings from different studies. For example, studies of chlormadinone acetate have found pregnancy rates of 1.1-12/100 woman-years. Results of trials of megestrol acetate suggested that a 500-mcg dose level yielded unacceptable pregnancy rates. No significant difference between various doses of norgestrel which have been studied were found (e.g., 50 and 75 mcg daily of dl-norgestrel or 30 mcg daily of the d-isomer). Pregnancy rate reported for most trials with this gestagen and also norethisterone and quingestanol were within an acceptable range. With 1 exception, pregnancy rates reported in trials of lynestrenol were remarkable low. Cumulative results of trials with various gestagens show Pearl Index rates between 2 and 3, except for lynestrenol. Dose level was the critical variable; i.e., it must be sufficiently high to exert antifertility action and low enough to avoid a high incidence of irregular bleeding. Apart from menstrual irregularities, other side effects from the minipill seem minor and in general less severe than those encountered with combined oral contraceptives.
Cyproterone acetate (CPA) a potential male contraceptive: further studies on the interactions with endocrine parameters.
Berlin, Germany, WHO-CCCR, . 11 p.This unpublished paper is the transcript of a conference proceeding, but the figures referred to textually are not included in the document. This study evaluated the effects of medium dose cyproterone acetate (CPA), 10-30 mg/day, on gonadotropin and peripheral androgen levels. On the average, luteinizing hormone (LH) concentrations were about 35% lower during CPA administration; similar observations were made for follicle stimulating hormone (FSH). CPA medication resulted in a significant reduction of LH response to LH-releasing hormone (RH); FSH increments following LH-RH stimulation were considerably smaller than those of LH and were hardly distinguishable from spontaneous FSH fluctuations. LH-RH double stimulation resulted in a slow but continuous rise of T without distinct peaks of borderline significance. CPA administration caused a highly significant elevation of serum prolactin in 7/10 males. In summary, medium dose CPA exerted the following effects on the hypothalamo-pituitary-testicular axis during the 1st 12 weeks of administration: 1) suppression of basal LH, FSH, T, and dihydroT; 2) abolition of the spiking phenomenon of androgen secretion; 3) suppression of LH-RH mediated secretion of LH and FSH; and 4) elevation of basal prolactin.
A.I.D.'s research program to develop new and improved means of fertility control. (Statement, May 2, 1978)
In: United States. Congress. House of Representatives. Select Committee on Population. Population and development: research in population and development: needs and capacities. Vol. 3. Hearings, May 2-4, 1978. Washington, D.C., U.S. Government Printing Office, 1978. p. 287-319USAID, in attempts to develop and improve means of fertility control, spent $4.8 million on new ways to control corpus luteum function and block progestational activity, $4.4 million to develop gonadotropin releasing factors, and $6 million on prostaglandins as a means of inducing the menses or terminating pregnancy in the second trimester. Studies at Johns Hopkins University developed thyrotropin releasing hormones to ensure postpartum infertility without interfering with lactation. Research to improve current forms of birth control amounts to $16.5 million. Side effects of oral contraceptives, single aperture laparoscopic sterilization, reversible male sterilization, and tissue glues for non-surgical female sterilization are some of the new techniques being funded by USAID. $19 million has been allocated to evaluate contraceptive programs in developing countries. Funds have come from DHEW, the Ford foundation, the Population Council, pharmaceutical companies, and WHO. Although improved birth control is desireable, money is best spent supplying available methods to developing countries.
In: Morris, N. and Arthure, H. Sterilization as a means of birth control in men and women. London, Peter Owen, 1976. p. 80-100Vasectomy was 1st used at the start of the 20th century and became prominent in the 1950s in family planning programs in Asian countries. The secondary sex characteristics do not change after vasectomy, and there is normal erectile power, libido, orgasm, and ejaculatory volume. Spermatogenesis continues normally in men following vasectomy, and plasma testosterone levels remain unchanged. Vasectomy involves cutting both vasa deferentes through an incision in the scrotum which is usually performed with local anesthesia without hospitalization. Preliminary counseling is necessary so that both partners understand the nature and effects of the operation. Semen banks may be used when available for men undergoing vasectomy. There is no evidence for the greater efficiency of 1 technique over the other. Patients must submit sperm samples for examination after 8-12 weeks and then every 4 weeks until 2 consecutive specimens are negative. Possible complications include: 1) a vasovagal reaction; 2) skin discoloration; 3) edema of the scrotal skin, 4) postoperative pain, 5) infection; 6) ulceration and gangrene of the scrotal skin, and 7) hydrocele or epididymo-orchitis. Successful reanastamosis of the vas deferens with reappearance of sperm can be accomplished in 50-80% of the patients, and the semen is not of quality to insure impregnation in 1/4 of these cases.
Injectable progestogens - officials debate but use increases. Les progestatifs injectables : les autorites en debattent, mas l'usage s'en repand.
Population Reports. Series K: Injectables and Implants. 1975 Mar; (1): p.A report on the status of the injectable contraceptive agents, Depo-Provera (depot medroxyprogesterone acetate) and Norigest is presented. Depo-Provera is distributed in 64 countries, though it is not available in the U.S., the United Kingdom, and Japan. The drug is usually administered in single 150 mg injections every 3 months, and doses of 300-400 mg every 6 months have been studied. The contraceptive effect of Depo-Provera is primarily through its ability to inhibit ovulation. Norigest exerts its effect by altering the cervical mucus. The suppression of ovulation is most likely caused by action on the hypothalamus-pituitary axis, resulting in inhibition of the luteinizing hormone surge. Depo-Provera causes an atrophic endometrium, while Norigest has varying endometrial effects. The reported pregnancy rates for Depo-Provera are usually less than 1%, while those for Norigest are slightly higher. Most method failures occur either shortly after the 1st injection or at the end of an injection interval. Menstrual disorders have been the primary reason for discontinuation. The injectables can cuase shorter or longer cycles, increased or decreased menstrual flow, and spotting. Depo-Provera users experience increased amenorrhea with continued use, while normal cycles increasingly reappear in Norigest users. Cyclic estrogen therapy has been effective in treating excessive or irregular bleeding and amenorrhea. Long-acting estrogen injections have been administered in combination with Depo-Provera or Norigest, though the studies are limited in number. Weight gain of up to 9 pounds has been reported for users of Depo-Provera. Some researchers have found that Depo-Provera raises blood glucose levels, while others have reported it does not. No adverse effects have been reported for injectables on blood clotting, adrenal or liver function, blood pressure, lactation, and metabolic or endocrine functions. The continuation rate for Depo-Provera is reportedly higher than that for oral contraceptives. Generally, 60% of the acceptors will use the method for at least 1 year. Effective counseling on the menstrual alterations resulting from injectables can increase continuation of the method. The return of fertility in Depo-Provera users usually requires 13 months from the time of the last injection, while the afertile period in Norigest users is about 6 months from the time of the last injection. Instances of fetal masculinization as a result of Depo-Provera use have not occurred. The possibility that Depo-Provera can cause cervical carcinoma in situ has not been substantiated by the evidence; doubt about this possible association has prevented its approval as a contraceptive method in the U.S. Although Depo-Provera and Norigest have caused breast nodules in laboratory animals, there is no evidence to suggest that this effect would occur in human. Despite the advantages of injectables, family planning officials have been reluctant to permit its unrestricted use, primarily because it cannot be withdrawn guickly enough if problems arise and because the actual effect on fertility is not yet known. Nonetheless, the use of Depo-Provera has increased in recent years. The IPPF and the U.N. Fund for Population Activities currently supply the drug.
In: Sciarra, J.J., Markland, C. and Speidel, J.J., eds. Control of male fertility. (Proceedings of a Workshop on the Control of Male Fertility, San Francisco, June 19-21, 1974). Hagerstown, Maryland, Harper and Row, 1975. p. 274-307Literature on research approaches to permanent and relatively reversible methods of male fertility control is reviewed. Sources and expenditures for research into male fertility control are noted. Permanent methods discussed include electrocautery of the vas, transcutaneous interruption of the vas, vasectomy clips, chemical occlusion of the vas, and passive immunization. Reversible methods reviewed include vasovasotomy, intravasal plugs, and vas valves. Current research into animal models, reversibility after vas occlusion, nonocclusive surgical techniques, pharmacological alteration of male reproductive function, including adrenergic blocking agents, steroidal compounds, inhibitors of gonadotropin secretion, clomiphene citrate, organosiloxanes, prostaglandins, alpha-chlorohydrin, heterocyclic agents, and alkylating agents, and delivery systems for antifertility agents is discussed. Research into semen storage and improved condoms is also reviewed. As a relatively low proportion of funds are committed to research in male fertility control, a greater investment in applied and clinical research is warranted.