Development of Novel or Improved Infertility Technologies (R61/R33 Clinical Trial Optional)

The Department of Health and Human Services, through the National Institutes of Health, has released a Notice of Funding Opportunity (NOFO) to support the development of novel or improved infertility technologies under activity code R61/R33. The funding program is administered by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). This initiative aligns with NICHD’s mission to advance research on human development, reproductive health, and the improvement of fertility outcomes, especially in the context of assisted reproductive technologies. The program emphasizes the creation and validation of innovative technologies that may eventually be advanced to clinical development to improve treatment options for patients struggling with infertility. Infertility affects about 15% of couples worldwide, with causes attributed to both male and female factors such as genetic abnormalities, chronic health conditions, and environmental exposures. Despite advances in assisted reproductive technologies, the overall success rate of in vitro fertilization remains around 33%. The need for improved, cost-effective, and accessible fertility solutions is critical. NICHD has prioritized this effort under its strategic plan, particularly its reproductive health agenda, which seeks to develop new methods and technologies to enhance fertility stimulation, preservation, and successful outcomes. This phased award mechanism is structured into two parts: an exploratory R61 phase lasting up to two years, and a potential R33 phase lasting up to three years for projects that demonstrate proof-of-concept and meet milestone criteria. Clinical trials are not permitted during the R61 phase but may be included in the R33 phase. Applicants must clearly define transition milestones that include measurable proof-of-concept evidence and demonstration of a reasonable safety profile for the proposed product. Projects must be milestone-driven with quantitative go/no-go criteria, ensuring rigorous assessment of feasibility and impact before transitioning to the second phase. The scope of supported research is broad, covering the development or improvement of drugs, devices, diagnostic tools, digital health platforms, laboratory tests, and machine learning applications aimed at improving reproductive health outcomes. Examples include improving gamete quality, optimizing implantation timing, reducing IVF costs, and designing AI tools for embryo assessment. Certain areas, however, are excluded from consideration, including contraceptive development, cancer therapies, and general gynecological treatments not directly addressing infertility. Applicants must focus on a single product and provide clear pathways for clinical relevance. Funding for this initiative is limited to $300,000 in direct costs per year during the R61 phase and up to $471,000 per year in direct costs during the R33 phase. NICHD intends to allocate $3.3 million in FY 2026 to fund up to 11 awards in the R61 phase, with up to 7 projects eligible for transition into the R33 phase. The maximum project period across both phases is five years. Applications that fail to present clear milestones, provide proof-of-concept, or demonstrate a reasonable safety profile will not be considered for funding. Matching funds are not required for participation in this opportunity. Applications may be submitted by a wide range of eligible entities, including higher education institutions, nonprofits, for-profit organizations, tribal governments, state and local governments, school districts, public housing authorities, and foreign organizations. NIH’s updated policies on international collaborations apply, and foreign subawards will not be funded unless specifically allowed under designated NOFOs. Applicants must complete required registrations in SAM.gov, eRA Commons, and Grants.gov before submission, and principal investigators must have an active eRA Commons account. Failure to meet these administrative requirements may result in delayed or rejected submissions. The application window opens on October 20, 2025, and closes on November 20, 2025, at 5:00 PM local time of the applicant organization. Applications will undergo initial peer review in March 2026, followed by advisory council review in May 2026. The earliest anticipated award start date is July 2026. The NOFO was posted on September 23, 2025, and will expire on November 21, 2025. Applications must be submitted electronically via the NIH ASSIST system, institutional system-to-system platforms, or Grants.gov Workspace. For scientific or research-related questions, applicants may contact Travis Kent, PhD, at travis.kent@mail.nih.gov, and for grants management questions, Mahasin Ingram at mahasin.ingram@nih.gov. General inquiries may also be directed to NIH’s eRA Service Desk and Grants.gov Customer Support.

Applicants are strongly encouraged to include intellectual property milestones, provide detailed proof-of-concept and safety milestones, and submit early to allow time for error correction in the application systems