Research Initiative

Rethinking Male Hygiene to Protect Maternal Health

Evidence suggests the male genital microbiome plays an underappreciated role in vaginal health and birth outcomes. We are investigating a non-surgical, reversible approach to addressing this gap.

The Unaddressed Gap

An Overlooked Source of Recurrence

Bacterial vaginosis (BV) affects between 23% and 29% of women of reproductive age globally, and is among the most common conditions associated with preterm birth, low birth weight, and ascending intrauterine infection. Despite decades of treatment, recurrence rates remain high — in clinical trials, BV recurrence within 12 weeks of antibiotic treatment has reached 63%.

A growing body of evidence points to why: current treatments focus exclusively on the female partner, ignoring the male genital tract as a potential reservoir for anaerobic bacteria. Prospective cohort studies have demonstrated that the microbiome composition of a man's penis can predict incident BV in his female partner with over 80% accuracy. Without addressing this reservoir, reinfection is a predictable outcome.

Preterm birth remains the leading driver of neonatal mortality globally, responsible for more than one-third of neonatal deaths. The causal link between vaginal dysbiosis and spontaneous preterm birth is now well-established. Addressing the root of that dysbiosis — including partner transmission — may be one of the most underexplored opportunities in maternal health research.

The Causal Chain
1
Male Reservoir

Anaerobic bacteria in the subpreputial space

2
Sexual Transmission

Transfer during intercourse

3
Vaginal Dysbiosis

Disruption of Lactobacillus-dominant state (BV)

4
Ascending Infection

Cervical inflammation & intrauterine infection

5
Adverse Outcomes

Preterm birth · low birth weight · neonatal sepsis

Each link in this chain is supported by peer-reviewed evidence. Circunaro's intervention targets link 1.

Our Approach

A Mechanical Intervention, Not a Pharmaceutical One

Circunaro is investigating a medical-grade silicone ring designed to reduce the anaerobic microenvironment under the foreskin — the conditions that support pathogenic bacterial communities associated with BV transmission. The hypothesis draws directly from the mechanism behind surgical male circumcision, which has been shown in randomized trials to reduce BV risk in female partners by 40–61%. The Circunaro device proposes to achieve a comparable ecological shift without surgery.

Research Initiative

Built on Existing Evidence

CE Marked

CE-Marked Device

The Circunaro ring was CE-marked as a Class I medical device, manufactured in medical-grade silicone. This regulatory history provides a safety foundation for clinical research.

RCT · NEJM 2025

StepUp Trial (NEJM, 2025)

The first RCT proving partner treatment reduces BV recurrence — from 63% to 35% in 12 weeks. This landmark study validates the male genital tract as a clinically modifiable driver of women's reproductive outcomes.

Rakai RCT

Rakai Circumcision Trials

Randomized trials by the Rakai Health Sciences Program established that circumcision reduces penile anaerobic bacteria and BV in female partners by 40%, providing the biological precedent for Circunaro's mechanism.

Ongoing

Research Dialogue

We are in dialogue with research teams in East Africa and Europe interested in collaborative study design and evidence generation.

Interested in Collaborating?

We are looking for researchers, clinicians, and institutions with the capacity to design and conduct the studies needed to test this hypothesis.

Explore Collaboration Opportunities