# Whole Ovary Vitrification for Fertility Preservation

> **NIH NIH R44** · 21ST CENTURY MEDICINE, INC. · 2020 · $832,615

## Abstract

PROJECT SUMMARY
The long-term goal of this proposal is to develop a safe, effective and user-friendly vitrification system for
cryopreservation of whole human ovaries. In the U.S., over 140,000 girls and women age 0-49 are diagnosed
with cancer annually. While improved diagnosis and treatment have led to increased survival rates (75% in
premenopausal and 85% in childhood cancer patients), devastating side effects of cancer therapies include
premature ovarian failure, infertility and menopause-related health risks. While cryopreservation of embryos
and oocytes are effective, ovarian cortex and whole ovary cryopreservation is the only option for future fertility
in prepubertal patients and those who require immediate cancer treatment. Cryopreservation of whole ovaries,
compared to ovarian tissue, has added advantages of 1) preserving all classes of follicles, which can be used
for in vitro maturation, 2) longer graft lifespan, and 3) faster recovery supported by existing blood vessels after
transplantation with vascular anastomosis. However, current methods for whole ovary cryopreservation are
suboptimal and there is no technology designed for cryopreserving human ovaries, despite it being the best
choice for prepubertal cancer patients for future fertility and intact endocrine function for decades without the
help of exogenous hormones. The proposed research is part of 21st Century Medicine’s more general program
of developing superior organ cryopreservation systems, including cryoprotective agent (CPA) solutions,
perfusion apparatus (hardware and software) for CPA loading and unloading, and liquid nitrogen storage units.
This Phase II will help us initiate our effort in achieving our ultimate goal as an organ banking company. Our
company has successfully demonstrated functional preservation of vitrified rabbit kidneys after transplantation.
In this SBIR Phase II study, we will validate and continue improving our success thus far in whole ovary
vitrification using large animal models of ovary transplantation in pigs and sheep (sheep has an established
ovary transplant procedure and their ovarian structure is closer to the human than the pig). We will also
develop a nonhuman primate preclinical model for ovary transplantation as well as characterize the cryogenic
properties of monkey ovaries. Furthermore, we will finalize the Ovary Perfusion Device and develop a closed
system for storing individual cryopreserved ovaries for eventual clinical use. The resultant technology of this
Phase II project will be the first perfusion unit designed for the human ovary and can simultaneously control
temperature, pressure, flow rate and CPA concentration with a build-in feedback mechanism to maintain
constant pressure during perfusion. Upon successful completion of Phase II, we will submit a Phase IIb
application to include fertility trials using the nonhuman primate model, human tissue xenografting
experiments, and finalizing strategies for commercialization. T...

## Key facts

- **NIH application ID:** 10156757
- **Project number:** 1R44HD104531-01
- **Recipient organization:** 21ST CENTURY MEDICINE, INC.
- **Principal Investigator:** Alison Y Ting
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $832,615
- **Award type:** 1
- **Project period:** 2020-09-21 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10156757

## Citation

> US National Institutes of Health, RePORTER application 10156757, Whole Ovary Vitrification for Fertility Preservation (1R44HD104531-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10156757. Licensed CC0.

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