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The HOPE Registry aims to enroll approximately 400 women of reproductive age over a three year period. Women participating in the Registry will have their oocytes frozen, thawed and the resulting fertilized embryos transferred. It is open to all qualified investigators across the country who are freezing and later thawing oocytes for embryo production. Local ethics committee or Institutional Review Board approval will be required for each participating center. The HOPE Registry will be conducted according to the principles of good clinical practice and the Declaration of Helsinki, and will be listed on clinicaltrials.gov.
"As a leader in fertility health, EMD Serono is proud to support the HOPE Registry to validate oocyte cryopreservation techniques that may prove to be a viable option to assist women in preserving their fertility," said Fereydoun Firouz, President and CEO of EMD Serono. "We are thrilled to play a major role in accumulating data on this new fertility treatment."
Data will be collected according to the protocol in a uniform manner for every enrolled patient. Systematic tracking will continue for an additional two years to obtain birth outcomes from patients who achieved pregnancy within the third year of enrollment. Cumulative results from the HOPE Registry will be presented and discussed during an annual investigators' meeting. These results will subsequently be published to provide a widely accessible resource for patients and their caregivers regarding the safety and efficacy of the different egg freezing techniques, as well as the postnatal outcomes of the babies born from embryos generated from frozen/thawed oocytes.
Cancer patients should consult with an oncologist before considering oocyte preservation. Fertility treatment is not recommended for patients with sex hormone dependent tumors of the reproductive tract and accessory organs.
About EMD Serono, Inc.
EMD Serono, Inc., an affiliate of Merck KGaA,
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| SOURCE EMD Serono, Inc. Copyright©2008 PR Newswire. All rights reserved |
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