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HB-Sperm Injections Associated With Higher Clinical Pregnancy Rates Than Standard Intracytoplasmic Sperm: Presented at ASRM

By Deborah Brauser

ATLANTA -- October 25, 2009 -- In vivo fertilisation (IVF) injection with hyaluronan-bound (HB) sperm selected using a sperm selection device (SSD) can lead to a higher clinical pregnancy rate than the standard intracytoplasmic sperm injection (ICSI), especially for patients with abnormal high-binding assay (HBA) scores, according to interim results from an ongoing multicentre study presented here at the 65th Annual Meeting of the American Society for Reproductive Medicine (ASRM).

"Typically, we choose sperm based on shape and motility," said lead author Kathryn C. Worrilow, PhD, Pennsylvania State University College of Medicine, Hershey, Pennsylvania. "Now, we choose it for those things and by how it binds to the hyaluronan."

"About 10 years of research has shown that hyaluronan-endowed sperm are developmentally more mature and more stable and are going to give the embryologist a tremendous advantage," she added.

The SSD dishes contain microdots of hyaluronan. "With these, the hyaluronan has been immobilised and put on petri dishes so that embryologists can then choose more optimal sperm for injection," explained Dr. Worrilow at a presentation on October 20.

For the study, 378 patients were enrolled at 9 IVF centres across the United States and randomised to the ICSI control group (n = 101), SSD study group (n = 112), or a non-participatory group (n = 165). The treatment groups were further stratified by a low HBA index of <= 60% (ICSI, n = 55; SSD, n = 52).

Those in the ICSI group received injections of sperm selected based on shape and motility. Those in the SSD group had injections of HB-sperm selected through the use of the petri dish and met the same criteria.

Results showed that the overall clinical pregnancy rate (cpr) was greater for the SSD-treated group than for the ICSI-treated group. In addition, the cpr associated with low HBA index patients in the SSD group was 76.5% versus 36.8% for those in the ICSI group.

"Overall, as the HBA score decreased, the improvement in cpr ranged from 26.7% to 39.7% when hyaluronan-bound sperm, or the [SSD dish] technology, was used in their therapy," said Dr. Worrilow.

She reported that the ongoing study is at about the halfway mark with 598 couples consented, as their total goal is 1,200 enrolled. "Our numbers continue to show the pattern that when the [patients] are injected with the sperm that was selected bound to hyaluronan, the clinical outcome was statistically significantly improved."

"The [SSD dish] technology may significantly enhance our ability to choose the functionally more competent sperm for injection into the oocyte, thereby improving the chances that a successful clinical outcome will result for the couple experiencing male factor etiology," concluded Dr. Worrilow.

Funding for this study was provided by Biocoat, Inc.

[Presentation title: A Multi-Site Clinical Trial Evaluating PICSI Versus Intracytoplasmic Sperm Injection (ICSI): Positive Clinical Outcomes Observed in a Prospective, Randomized and Double-Blinded Study. Abstract O-123]

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