EMD Serono Launches Landmark Patient Registry for Egg Freezing The HOPE Registry is an observational study undertaken to evaluate the safety and efficacy of oocyte cryopreservation (egg freezing) techniques
The objective of the HOPE Registry is to track the outcome of oocyte cryopreservation cycles and to validate the efficacy of the different techniques used to freeze and thaw eggs. The HOPE Registry will evaluate the two techniques commonly used in egg freezing, "slow-cooling" and "vitrification," and assess the safety of these procedures by systematically capturing information to determine if the babies born from different egg freezing techniques are healthy. The data collected will be thorough in scope and will include patient demographics as well as specifics on the different laboratory procedures used to freeze, thaw and fertilize each oocyte and produce the transferable embryos. Additionally, pregnancy outcomes will be tracked and evaluated, as well as the health and development of the children following birth and at one year of age.
Although egg freezing remains an experimental procedure, in recent years the number of pregnancies resulting from the fertilization of thawed oocytes has increased. Estimates show that almost 500 children have been born worldwide from these techniques and only four of these children (0.8%) had a genetic abnormality. This success is due, in large part, to a better understanding of the physiology of eggs as well as advancements leading to improved freezing technologies. The HOPE Registry will help support the goals of the ASRM's Practice Committee, which called for more studies on the health outcomes of children born from various egg freezing techniques in 2006.
"We need to validate the safety and efficacy of egg freezing for it to
become a more widely available option for women who for a variety of reasons
would like to preserve their fertility. The HOPE Registry is an exciting
vehicle that will assist us in the evidence-gathering process and will
facilitate the furthering of the science and the acceptance of oocyte
cryopreservation as an effective clinical practice," said Dr.
One patient group that has benefited significantly from egg freezing is women who have been diagnosed with certain types of cancer during their reproductive years and wish to preserve their fertility before cancer treatments. This is one of the few viable options for these women, who require chemotherapy and/or radiotherapy treatments that may cause infertility and premature ovarian failure depending on their cancer diagnosis.
"Each year, more than 140,000 people are diagnosed with cancer during
their childbearing years," said Ms.
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
"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
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, Darmstadt,
For more information, please visit www.emdserono.com.
About Merck KGaA
Merck is a global pharmaceutical and chemical company with total revenues
For more information, please visit www.merck.de.
SOURCE EMD Serono, Inc.