Legacy Launches $1M Study Advancing At-Home Semen Collection for Assisted Reproduction Technology

NEW YORK, May 11, 2026 /PRNewswire/ -- Legacy, the leading male fertility clinic and at-home sperm testing and cryopreservation platform, today announced the Sperm Study, a clinical research initiative backed by an R&D investment of over $1 million and designed to evaluate and optimize the use of at-home semen collection for assisted reproductive technologies (ART), including IVF and IUI.

Prospectively enrolling up to 250 participants across two phases, this study represents one of the most comprehensive investigations to date into how specimen shipment, handling, and cryopreservation impact sperm quality and is expected to set a new benchmark for scientific rigor in the rapidly growing field of at-home fertility testing. This study is being conducted in collaboration with IVF Academy USA.

Raising the bar for clinical evidence in at-home fertility care

To date, validation work in at-home semen collection has been limited in important ways. Studies have largely enrolled normozoospermic men only, relied on courier-transported rather than real-world-shipped specimens, and focused on short-term motility and concentration as primary endpoints.

Critical questions remain unanswered, particularly around 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. The Sperm Study is designed to close those gaps.

This multi-phase study will evaluate key sperm quality parameters including motility, DNA fragmentation, and post-thaw viability, while also validating the use of computer-aided semen analysis (CASA) as an alternative to basic manual semen analysis in the setting of mail-in semen analysis.

"With the increased utilization of at-home semen testing and cryopreservation, there is a critical need to ensure these specimens will perform adequately when used for assisted reproduction," said Legacy's Chief Medical Officer, Dr. Scott Lundy. "This study is designed to rigorously evaluate how at-home collection and transport impact sperm quality across a broad patient population and to translate those findings into improved protocols and optimized outcomes for both patients and providers."

Sperm study design and scientific approach

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. Importantly, this study 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 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, and the 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 high-quality, 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.

About Legacy

Legacy is the leading male fertility clinic in the United States, offering at-home semen analysis, sperm cryopreservation, and post-vasectomy testing. With a CLIA-certified, high-complexity andrology lab and one of the largest proprietary datasets in male reproductive health, Legacy is advancing access, data, and innovation in fertility care.

SOURCE Give Legacy, Inc.