Legacy, the male fertility clinic and at-home sperm testing platform, has launched the Sperm Study, a clinical research initiative backed by an R&D investment of over $1 million. The study is designed to evaluate and optimize the use of at-home semen collection for assisted reproductive technologies (ART), including IVF and IUI. It is being conducted in collaboration with IVF Academy USA.
Overview
The study addresses a gap in existing research on at-home semen collection. Prior validation work has largely enrolled only normozoospermic men (those with normal sperm parameters), relied on courier-transported rather than real-world-shipped specimens, and focused on short-term motility and concentration as primary endpoints. Critical questions remain about how samples with varying quality perform under genuine end-to-end shipping conditions and how those samples hold up in the contexts that matter most clinically: IVF and IUI.
Study design
The Sperm Study is a prospectively accruing cross-sectional study in which paired semen samples are analyzed across multiple timepoints and during the shipment process. It enrolls participants across a range of semen quality profiles — not solely normozoospermic men — and evaluates samples under genuine shipping conditions experienced by real specimens.
Key study components include:
- Direct comparison of computer-aided semen analysis (CASA) vs. manual analysis at baseline
- Evaluation of motility decline over time and in relation to shipment conditions
- Measurement of DNA fragmentation pre- and post-shipment and cryopreservation
- Assessment of post-thaw sperm viability and yield
- Development of predictive algorithms for IVF/IUI sample sufficiency
The study will also examine how factors such as transit time, concentration, and storage conditions impact outcomes, with the goal of generating generalizable insights for clinical practice.
Multi-phase rollout
Phase 1 includes 100 participants and approximately 1,500 total assays, with expected completion in 2026. Phase 2, planned for later in 2026 and into 2027, will expand the study with additional participants, bringing the total to up to 250 to enable broader validation across a more diverse patient population.
Impact on clinical practice
Findings from the Sperm Study are expected to directly inform and improve specimen collection protocols for at-home use, shipping and handling standards for semen samples, cryopreservation practices, and clinical decision-making for IVF and IUI readiness. By generating controlled data across a clinically representative patient population, Legacy aims to provide fertility clinics, researchers, and patients with greater confidence in the use of mail-in semen testing and cryopreservation as part of standard reproductive care.
Bottom line
Legacy's $1 million investment in the Sperm Study represents one of the more comprehensive investigations to date into how specimen shipment, handling, and cryopreservation impact sperm quality. The results could set a new benchmark for scientific rigor in the at-home fertility testing field, potentially expanding access to ART for a broader patient population.