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Contraline teams up for sperm analysis in trial of male birth control device
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ADAM is a gel-based implant that prevents sperm from passing through the vas deferens. Source: Shutterstock/Home creator.
The first-in-human trial of Contraline's male contraceptive device will receive a home test kit for sperm detection from DNA Diagnostics Centre (DDC).
Contraline has developed a product called ADAM, which is a hydrogel implant designed to prevent sperm from passing through the vas deferens. The insertion procedure is anticipated to take under 30 minutes, and the device, which is non-hormonal, dissolves after its effective period, making it a temporary contraceptive solution.
The initial human trial of ADAM (NCT05134428) is currently underway in Australia. As per DDC, 25 patients who were candidates for a vasectomy have instead opted to participate in this trial by receiving the ADAM system. Contraline's current priority is to observe the long-term safety and effectiveness of this new system.
The main result being measured is the total count of any adverse events that arise from the treatment within 30 days after the procedure. One of the secondary outcome measures over a three-year period is the proportion of subjects who reach a sperm count of zero, which is termed azoospermia. Additionally, the study will evaluate the percentage of participants who achieve virtual azoospermia, defined as having a sperm count of less than 100,000 per milliliter.
DDC announced that its test, named SpermCheck Vasectomy, will be included in the study after receiving approval from the Human Research Ethics Committee. This test, which has been cleared by the US Food and Drug Administration, aims to verify the success of a vasectomy by identifying sperm in semen samples. The company mentioned that the test will be utilized to track the performance of the male contraceptive device as it is being used.
Contraline, a company based in Virginia, USA, reported encouraging initial outcomes earlier this year. The implantation procedure achieved a 100% success rate, and the ADAM device resulted in a 99.6–100% decrease in motile sperm count within 30 days following the procedure. Additionally, no major negative side effects were observed.
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Kevin Eisenfrats, the CEO of Contraline, expressed enthusiasm about incorporating SpermCheck Vasectomy into their clinical trial. He explained that it makes perfect sense to pair an at-home diagnostic tool like SpermCheck Vasectomy with their male contraceptive product, ADAM, as this combination will allow patients to verify the effectiveness of ADAM in the comfort and privacy of their own homes.
In the realm of male birth control, Next Life Sciences is working on a product they refer to as Plan A, or Vasalgel. This method entails obstructing the vas deferens using a hydrogel implant. Currently, Vasalgel has not progressed to clinical trial testing.
A 2023 survey featured in the journal Contraception found that approximately three-quarters of the 2,066 men surveyed expressed their willingness to try new forms of male birth control.
The field of vasectomies is making progress as well. Signati Medical is currently testing a new device in clinical trials, which is designed to speed up the procedure and improve recovery time.
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