Publication of OvaScience’s AUGMENT Fertility Treatment Shows Statistically Significant Improvements in Embryo Selection and Transfer Compared to Standard IVF
Real-World Experience from International IVF Clinics Reported in
The report, published today in the peer-reviewed,
“This first publication of AUGMENT experience from different IVF clinics
shows that AUGMENT treatment resulted in higher ongoing clinical
pregnancy rates and healthy births when compared to standard IVF,” said
The eggs retrieved from a group of 25 patients at Fakih IVF were prospectively allocated into two treatment groups: one group received the AUGMENT treatment and the other group received standard IVF with ICSI (intracytoplasmic sperm injection). All 25 patients met the inclusion criteria for the retrospective analysis that required embryo transfer be limited to only one treatment group, as including embryos from both treatment groups would prevent an accurate assessment of treatment benefit. Embryos that were transferred were selected from the one treatment group that had the highest quality embryo(s) for transfer. Accordingly, in patients where more than one embryo was transferred, embryos were only selected from the one treatment group that included overall highest quality embryos. Embryos were selected based on standard morphogenetic analysis, which is composed of two measures. The first is an objective analysis to identify genetic disorders (e.g., cystic fibrosis) and chromosomal abnormalities (e.g., aneuploidy). This is called preimplantation genetic diagnosis (PGD) or preimplantation genetic screening (PGS). The second is an analysis of morphology performed by the embryologist. There is a standard grading system used to evaluate the embryos.
Following the PGD/PGS assessment, there were 9 patients for whom no embryos met the criteria for transfer. The majority of embryos were chosen based on PGD/PGS, an objective measure of embryo quality. The remaining embryos underwent morphological assessment. The morphogenetic analysis resulted in 14 embryo transfers from the AUGMENT group and 2 from the IVF-only group, which was statistically significant and suggestive of improved embryo quality with the AUGMENT treatment.
Ongoing clinical pregnancy rates in these women, who previously had a 0 percent live birth rate, were higher in the AUGMENT treatment group, with 8 women out of 14 with embryo transfers resulting in ongoing clinical pregnancies that are expected to result in live births (and include the births of two sets of twins). There were 0 women with ongoing clinical pregnancies out of 2 with embryo transfers in the IVF-only group. In the intent-to-treat (ITT) analysis of all 25 patients, there was a statistically significant improvement in pregnancy rates with the AUGMENT treatment compared to the IVF-only group. (See Figure 1, pg. 5 of publication)
“Evaluating the AUGMENT treatment in the same woman during the same IVF
cycle eliminates many variables and provides clinically meaningful
insight into the positive impact the treatment can have for patients,”
The publication also included a summary of patients treated at TCART
(n=34) and Fakih IVF (n=59), demonstrating improvements in pregnancy
rates above the patients’ historic IVF success rates. Prior to the
AUGMENT treatment, patients collectively underwent 328 IVF cycles, and
had a 2 and 1.4 percent live birth rate per IVF cycle initiated in
Live Birth Rate per
9 patients with 23 frozen embryos
|Canada and UAE Have Reported Six Babies Born with the AUGMENT Treatment|
“As with the introduction of other new fertility technologies, we
anticipated that IVF clinics would gain experience using the AUGMENT
treatment by taking various approaches to demonstrate benefit,” said
IVF is the standard treatment for infertility, yet it fails the majority of the time. Poor egg health is a major cause of IVF failure, and data has demonstrated that the decline in egg health is largely due to a reduction in energy production. The AUGMENT treatment is designed to improve egg health by supplementing the energy in mature eggs during IVF.
This press release includes forward-looking statements about the Company’s plans for the AUGMENT treatment and its two fertility treatments in development. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: the possibility that international IVF clinics that we work with may determine not to begin or continue providing the AUGMENT treatment for commercial or other reasons; our expectation that the AUGMENT treatment and OvaPrime treatment meet the requirements of a class of products exempt from premarket review and approval under applicable regulations in those countries where we have launched or plan to introduce the AUGMENT treatment and plan to introduce the OvaPrime treatment; the commercial ramp up of the AUGMENT treatment, which we expect will depend upon continued use of the AUGMENT treatment in our partner clinics in new and existing regions, significant uptake in the UAE as a result of the recent coverage, and other programs that include driving first-line use of the AUGMENT treatment, and further results from ACE clinic experience as they become available; the science underlying our treatment and treatments in development (including the AUGMENT, OvaPrime and OvaTure treatments), which is unproven; our ability to obtain regulatory approval where necessary for our potential treatments; our ability to develop our potential treatments, including the OvaPrime and OvaTure treatments, on the timelines we expect, if at all; our ability to commercialize the AUGMENT treatment and our potential treatments, including the OvaPrime treatment, on the timelines we expect, if at all; as well as those risks more fully discussed in the “Risk Factors” section of our most recently filed Quarterly Report on Form 10-Q and/or Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect our current views with respect to future events. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our view as of any date subsequent to the date hereof.