Dan Scott | Health Science Correspondent
The quest for a reversible male contraceptive which does not rely on barrier methods (condoms) still remains. While for the past fifty years females have been given a monopolised opportunity with a myriad of options, from a daily hormonal pill to an intrauterine device to prevent egg release, the male “pill” remains something of science-fiction.
Research is hot in this area, however, and proposals have been made which could make male contraception a choice within the next decade. A hormonal pill is in development but the challenge remains that, as opposed to blocking the release of one egg per month, there is difficulty in ensuring that the same action can be maintained from the hundreds of million of sperm per millilitre of semen.
Several compounds have been trialled and tested nonetheless. A compound found in the cotton plant in China was linked to low fertility in males during the 1920s, which led to further studies later in the 20th century. Gossypol was trialed and, although successful as a contraceptive with little hormonal side effects, other issues such as irreversibility in one in five men made it unacceptable for use. Reversible fertility has been suggested by a common angina (a heart disease leading to chest pain following exercise or stress) and blood pressure managing agent, nifedipine. This commonly prescribed tablet which blocks excessive calcium influx in the heart is said to have action at a sperm’s capability in synthesising membrane lipids, and thus function. Research to date, however, has been strictly conducted in cellular models without further human clinical trial progression. Such a study is unlikely due to its success as its licensed purpose. A study proving or disproving its contraceptive potential could lead to patients avoiding the use of this drug, which can lead to vast cardiac complications and discomfort. Most other efforts in this area focus on blocking specific protein synthesis methods in spermatogenesis (sperm formation) in order to prevent proper sperm function.
The Parsemus Foundation is an American charity-slash-crowdfund agency that aims, according to their website, to support “low-cost solutions neglected by the pharmaceutical industry”. Amongst aims to treat remission patients from breast cancer and new treatments for enlarged prostate (hyperplasia), the majority of their energy is focused on alternative contraceptive measures. One of the more unusual alternatives proposed was the development of the “Clean Sheets” pill. From a cocktail of eradicated blood pressure and schizophrenia medications from the 1950s, effects on smooth muscle prevented semen transport to the penis, leading to a “dry orgasm”. Not only would the lack of fluid present a contraceptive effect, but it could also play a role in the prevention of STD transition for those which use semen as a vector, such as HIV.
The most promising and clinically developed solution to date has been a polymer-based solution known as Vasalgel. It acts on the target of the vasectomy, the vas deferens, the vessel which connects the epididymis (the sperm producing tissue) to the ejaculation duct, thus preventing sperm transport and preventing sperm transport during ejaculation. While a vasectomy uses a scalpel or laser technology to cut the vas deferens leading to questionable reversibility, Vasalgel would be injected into the vas deferens, blocking the vas deferens due to the high viscosity gel formed. This could be effective for up to 5 years, and a further injection could reverse its blockade and return fertility practically immediately. While no human clinical trial data has been released, promising results have been shown in baboon studies, where male baboons were “sterilised” via this method and resulted in no pregnancy following contact and recorded sexual activity with female baboons. Developed as a cost-effective formulation with a similar action to a vasectomy procedure, which bypasses any hormonal knock on effects, this treatment could be available as early as 2017, subject to confirmation of safety and as market authorisation.
While this treatment comes roughly half a decade following the marketing of family planning methods for the opposite sex, questions still have to be answered. Will men be willing to take this treatment? Will women trust men to have truly had such a procedure, or take a daily tablet with good compliance? Will the “stick” as opposed to the “snip” rouse the same challenges for men which traditionally come with vasectomy, such as mental loss of masculinity which could have a knock on effect on performance?
Several general practitioners were interviewed by the University Times to tackle these questions from a professional and experienced viewpoint. Members from a busy south-east practice have discussed the matter with female patients, with the consensus being that men in a stable relationship would probably be much more compliant with a male pill as opposed to their younger, less attached counterparts. Those who would undergo a vasectomy would usually be in the 35-45 age bracket and they have not had patients without children presenting. An issue that has also been cited is the fact that there is currently no public vasectomy service available in some areas. Nationally there is also inadequate reimbursement to GPs for fitting the Mirena intrauterine coil in medical card patients so this service is not always provided. This poses challenges for couples who have completed their families and are struggling to make ends meet as these procedures can be costly privately and there are long waiting lists if available publicly.
Another female GP based outside of Dublin commented that, following her near 30 years of practice, she feels women themselves prefer to be in control of family planning issues as “women are the ones who get pregnant and they are the ones who wish to be sure”. There has never been an enquiry in practice regarding a reversible male contraceptive measure, and generally a female patient on her own will enquire about contraceptive measures, or will do so accompanied by a reluctant male that perhaps feels a degree of co-responsibility. With regards to vasectomy procedures, a lack of comfort is clearly seen in many by this practitioner, which would prompt them to reconsider subject to any hesitancy. Long term effects due to a psychological barriers following the procedure is common in this viewpoint, although it is easy to find no direct correlation between both.
We spoke to two vasectomy specialists, with the procedure being the nearest competitor to Vasalgel. The average male patient presenting for a vasectomy is cited at roughly 34, having had children. A handful of procedures have been conducted in patients under 25, mostly in the case of clients with genetic inheritance concerns for their potential offspring or in intellectually challenged men with parental consent. One specialist predicts that about 15% of couples in Ireland will choose a vasectomy as a long term contraceptive measure, while the other has practice in performing in excess of thirty thousand procedures during their professional timespan. If you’re interested in a vasectomy along with other issues concerning men’s health, visit a urologist like the ones at Advanced Urology.
When asked about Vasalgel, one practitioner welcomed an alternative method to allow men to take charge of family planning, particularly avoiding the daily compliance issue. They predict the demographic of patients will likely shift to younger men to allow time to decide on whether to start or complete a family. While the procedure will most likely require the skills of a vasectomy professional, knowing when the gel is being injected into the vas deferens without surgical isolation poses a major challenge, and means the procedure will be performed under local anaesthetic and require an incision. Another practitioner has expressed concerns, stressing it not to be “wishful thinking”. Vasalgel will not be a “quick-fix” or “immediate method — like a vasectomy, Vasalgel’s effectiveness won’t be determined until 18 weeks after the procedure, which will be assessed via a sperm count and will require barrier methods of contraception in the meantime. Although this won’t affect every patient, this practitioner has predicted chronic pain as a side effect post-injection. While in modern vasectomy procedures, the vas deferens is generally left open at the testicular end preventing potential back pressure caused by the closure of the vessel, Vasalgel acts as a blockade to the vessel.
There are still other avenues in the pipeline that could allow males a selection of contraceptive measures. However, both attitudes and options theoretically pose risks prior to their exposure to a mass market. Although estrogen containing contraceptives increase the risk of thromboembolic events and progesterone can cause weight gain in females, a testosterone surge based hormonal pill for males remains something of an educated guess rather than one in development. Vasalgel does hold hope in the future from the analysis of animal studies, however until a clinical trial has been conducted with humans to establish a risk-benefit profile as well as efficacy, non-reversible and barrier methods remain the norm.
