DNA Diagnostics Centre (DDC) will supply a home test kit for sperm detection to Contraline’s first-in-human trial evaluating its male contraceptive device.

Contraline’s device – named ADAM – is a hydrogel implant that blocks sperm from travelling through the vas deferens. Inserted in a procedure expected to take less than half an hour, the non-hormonal device liquifies at the end of its lifespan, meaning it is not a permanent method of birth control.

ADAM is being investigated in the first-in-human trial (NCT05134428) in Australia. According to DDC, the trial has enrolled 25 patients who were suitable for vasectomy, instead receiving the ADAM system. Contraline is now focusing on monitoring long-term safety and efficacy.

The primary outcome is the number of all treatment-emergent adverse events through 30 days post-procedure. One of the three-year secondary outcome measures is the percentage of subjects achieving a sperm count of zero, known as azoospermia. The percentage of participants with virtual azoospermia, characterised as having a sperm count of fewer than 100,000/ml will also be assessed.

DDC said its test – called SpermCheck Vasectomy – will be integrated into the study following approval from the Human Research Ethics Committee. The US Food and Drug Administration-cleared test is designed to confirm the success of a vasectomy procedure by detecting the presence of sperm in semen samples. The company said the test will used to monitor the effectiveness of the male contraceptive device in real time.

Virginia, US-based Contraline announced positive early results earlier this year. There was a 100% successful implantation rate, with ADAM leading to a 99.6–100% reduction in motile sperm count within 30 days of procedure. No significant adverse events were reported.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Contraline’s CEO Kevin Eisenfrats said: “We are excited to integrate SpermCheck Vasectomy into the trial. It is a natural fit to combine an at-home diagnostic like SpermCheck Vasectomy with a male contraceptive like ADAM because it will offer patients the ability to know whether ADAM is working from the privacy of their own home.”

Also in the male contraceptive space is Next Life Sciences, developing what it calls Plan A, or Vasalgel. This also involves blocking the vas deferens with a hydrogel implant. Vasalgel is not yet being tested in clinical trials.

According to a 2023 survey published in the journal Contraception, around 75% of 2,066 male respondents said they would be willing to use new male contraceptives.

The vasectomy space is also advancing. Signati Medical is conducting a clinical trial for its device that aims to quicken the procedure and help enhance recovery time.