The HOPE Registry is an observational study undertaken to evaluate the safety and efficacy of oocyte cryopreservation (egg freezing) techniques ROCKLAND, Mass., Nov. 7
ROCKLAND, Mass., Nov. 7 /PRNewswire/-- EMD Serono, Inc., an affiliate of
Merck KGaA of Darmstadt, Germany, announced the launch of the Human Oocyte
Preservation Experience (HOPE) Registry surrounding next week's 64th Annual
Meeting of the American Society for Reproductive Medicine (ASRM). The HOPE
Registry is the only comprehensive national patient registry in the United
States designed to study the safety and efficacy of oocyte cryopreservation
procedures, commonly known as egg freezing.
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. Alan Copperman,
Director of the Division of Reproductive Endocrinology and Vice-Chairman of
the Department of Obstetrics, Gynecology, and Reproductive Science at Mount
Sinai Medical Center in New York, and co-director of Reproductive Medicine
Associates of New York.
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.
Lindsay Nohr Beck is a cancer survivor who used oocyte cryopreservation
before starting chemotherapy. She is the Founder and Executive Director of
Fertile Hope, a nonprofit organization dedicated to providing reproductive
information and support to cancer patients and survivors.
"Each year, more than 140,000 people are diagnosed with cancer during
their childbearing years," said Ms. Nohr Beck. "The HOPE Registry is expected
to substantiate egg freezing as an option, so that fertility is one less
obstacle these patients may need to overcome in fulfilling their dreams of
becoming a parent and living the lives they imagined prior to their cancer
diagnosis."
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, Darmstadt, Germany, is a
leader in the US biopharmaceutical arena, integrating cutting-edge science
with unparalleled patient support systems to improve people's lives. The
company has strong market positions in neurodegenerative diseases, with
Rebif(R) (interferon beta-1a), as well as in endocrinology, with Saizen(R)
(somatropin (rDNA origin) for injection), Serostim(R) (somatropin (rDNA
origin) for injection) and Zorbtive(TM) (somatropin (rDNA origin) for
injection). EMD Serono is a leader in fertility treatments, with Gonal-f(R)
(follitropin alpha for injection), Luveris(R) (lutropin alfa for injection)
and Ovidrel(R) Prefilled Syringe (choriogonadotropin alpha injection). With a
clear focus on the patient and a leadership presence in the biopharmaceutical
industry, EMD Serono's US footprint continues to grow, with more than 950
employees around the country and fully integrated commercial, clinical and
research operations in the company's home state of Massachusetts.
For more information, please visit www.emdserono.com.
About Merck KGaA
Merck is a global pharmaceutical and chemical company with total revenues
of Euro 7.1 billion in 2007, a history that began in 1668, and a future shaped
by 32,458 employees in 59 countries. Its success is characterized by
innovations from entrepreneurial employees. Merck's operating activities come
under the umbrella of Merck KGaA, in which the Merck family holds an
approximately 70% interest and free shareholders own the remaining
approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated
and has been an independent company ever since.
For more information, please visit www.merck.de.
SOURCE EMD Serono, Inc.
