# Innovative 3D Printed Intravaginal Ring AnelleO-PRO, the first Single Administration of Progesterone for Infertility

> **NIH NIH R44** · ANELLEO, INC. · 2021 · $862,923

## Abstract

PROJECT SUMMARY
Infertility is a global health problem. In the US alone, ~1.7 million women are treated for infertility every year. To
improve infertility treatment, there is a strong need to promote patient-friendly methods for progesterone
supplementation in assisted reproductive technology (ART). Intravaginal rings, which are well tolerated by
women, are efficacious for contraception and hormone replacement therapy, and have high patient compliance,
are now in development for ART. However, developing effective IVRs to deliver progesterone beyond 7 days is
challenging due to limitations of current engineering processes, and difficulty in controlling release rates, thus
mandating drug-specific customized IVR designs. Our goal is to address these limitations by revolutionizing the
engineering and manufacturing processes for intravaginal rings, using a state-of-the-art 3D printing process
known as continuous liquid interface production (CLIP™). Using the automated CLIP process, we can engineer
and manufacture IVRs with surface geometries not achievable with traditional injection molding or extrusion,
which help control drug release. CLIP enables us to precisely fine-tune diffusion and release of drugs, to achieve
near complete release, and independently control IVR mechanical properties. Importantly, using CLIP, we can
manufacture IVRs that provide sustained release of progesterone to cover the entire ART treatment period in a
rapid and cost-effective single-step process. In this Phase II SBIR project, we propose to build on our existing
data from Phase I to optimize a progesterone IVR named AnelleO-PRO, test its efficacy in a relevant macaque
model, and conduct IND-enabling studies to support an IND-application. We will implement comprehensive
rational IVR design, using the highly relevant preclinical sheep and macaque models to characterize the safety,
pharmacokinetic profiles, and efficacy of optimized AnelleO-PRO. This multidisciplinary, cutting-edge approach
will develop a unique and highly innovative 3D printed CLIP IVR – AnelleO-PRO, delivering progesterone in a
long-acting, single administration treatment of infertility.

## Key facts

- **NIH application ID:** 10323463
- **Project number:** 2R44HD100190-02
- **Recipient organization:** ANELLEO, INC.
- **Principal Investigator:** Soumya Rahima Benhabbour
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $862,923
- **Award type:** 2
- **Project period:** 2019-09-19 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10323463

## Citation

> US National Institutes of Health, RePORTER application 10323463, Innovative 3D Printed Intravaginal Ring AnelleO-PRO, the first Single Administration of Progesterone for Infertility (2R44HD100190-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10323463. Licensed CC0.

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