FDA is here to stay...
are you ready?
By Wendy D. Latash,
FDA regulations governing donor eligibility requirements
for the fertility field went into effect this
past May. However, obtaining information on exactly
how the regulations affect fertility practices
(or other supporting agencies) has been widely
varied at best. Much of the interpretation on
how the FDA regulations affect a specific practice
are based on many variables such as: the types
of donor programs offered, which services are
outsourced (i.e. to a donor agency or sperm bank)
and what reproductive tissues are stored on-site.
regulatory changes sometimes occurring overnight
and affecting whole donor programs, fertility
practice personnel may find it enormously difficult
to keep up with the current state of affairs—not
to mention the difficulty of trying to figure
out what measures need to be taken to become FDA
compliant. Implementing changes and developing
a system for maintaining FDA compliance is challenging
on the best of days and overwhelming on the worst.
for a field that, for the first time ever, is
going to have the FDA walking through the door
any moment, one of the most critical pieces of
information to figure out is what is not
mentioned in the letter of the ruling—what
the FDA inspectors expect to see.
you are ready to hear the bottom line about the
regulations and what you can do to become FDA
compliant, join us as we invite Wendy D. Latash,
PhD, partner and Director of Advisory Services
for Jade Tree Solutions to provide the latest
information regarding FDA regulations. She will
give you the bottom line on the regulations themselves
as well as an insightful, real-world perspective
on what you can do to take action in your practice.
After the first hour of presentation, be ready
to ask your questions during our moderated hour-long
question and answer session.
guarantee that you will come away from this seminar
having a much deeper insight as well as some practical
tips for implementing the FDA regulations in your
practice. Don’t miss it!
D. Latash, Ph.D.
Jade Tree Solutions, LLC
The New Face of Infertility Treatment?
while giving an egg donor seminar, I saw a look
of shock and worry spread across the faces of
several young women as I informed them that significant
deterioration of a woman’s eggs begins after
the age of 35 making it difficult and eventually
impossible for her to conceive a healthy baby
naturally. A hand popped up from the crowd and
I was asked by a prospective donor in her late
twenties, “is there anything that I can
do to avoid being in this situation 10 years from
Cryopreservation, the scientific name for egg
freezing, may be the future of infertility treatment.
Although sperm and embryos (fertilized eggs) have
been successfully frozen for decades, the freezing
of unfertilized eggs has only recently been successful.
Egg freezing allows women to freeze and store
their eggs until they are ready to build their
families. Going one step further, egg freezing
allows for egg banking, the collection and freezing
of donor eggs for use in future frozen egg donor
cycles, to provide couples seeking donor eggs
with an alternative to timely and potentially
costly fresh egg donor cycles. While the benefits
of cyro-preserving eggs could prove to be tremendous
for those seeking solutions to their fertility
concern, physicians have not established egg freezing
as a standard fertility treatment. To do that,
ongoing clinical studies will have to show continued
improvement in the success rates of this practice.
Higher efficiency rates might ease women’s
minds as they chose to follow their dreams and
hold off on creating a family. Women have endless
opportunities these days to enrich their lives
outside the home. However, while women make their
mark in the professional world and delay their
family building, their biological clock tick,
tick, ticks itself away. Egg freezing offers women
planning to have children after the age of 35
the opportunity to slow down their biological
clocks. Women have the opportunity to store their
eggs during their reproductive prime for future
use when the time is right. Egg freezing also
offers hope to women about to receive cancer therapies
that could put their reproductive futures at risk
and women with endometriosis, premature ovarian
failure or early menopause. For these women egg
freezing is likely the best option for preserving
Freezing unfertilized eggs also allows for the
possibility of egg banking. If the science behind
thawing and fertilizing frozen eggs can be improved,
there may be a bright future for egg banking agencies.
Using frozen eggs has several advantages including
decreased geographical and financial barriers,
increased timeliness and less risk of a failed
screening process. But, the current disadvantages
of low and unproven effectiveness and drastically
lower success rates when compared to fresh donor
cycles cannot be ignored.
Cyropreservation remains relatively rare, with
only about 200 babies born worldwide through this
technique. However, new programs are making headlines
in their attempt to bring this practice to the
forefront of the fertility industry. The University
of Southern California’s fertility program
(USC Fertility: http://www.uscivf.org/)
was involved in the first reported case of pregnancy
from a frozen egg in 1986 and is currently completing
a self-funded study designed to evaluate the efficiency
of egg freezing. Their latest published success
rate is an unprecedented 63%, reflective of 5
out of 8 clinical trial patients achieving pregnancy.
Importantly though, the results are preliminary
and limited. The study was conducted on only 20
women age 35 or less.
It is hard to deny that egg freezing could revolutionize
the fertility industry. While the American Society
for Reproductive Medicine still considers egg
freezing investigational, dedicated fertility
specialists are doing their best to improve the
science and make it a widespread and viable option
for those facing infertility. In effect, egg freezing
stands to give women more choices than ever when
it comes to when and how they will chose to reproduce.
The Donor Source
Donor Source would like to offer
our supporting clinics FREE
EVENT PROMOTION in The
Source, our monthly e-newsletter.
Please send your calendar announcements to Newsletter@TheDonorSource.com
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25th of the preceding month. Therefore if you
would like to promote a special event you are
having in our October issue please make sure I
have the dates of your event and a link to your
site by October 25th. Please feel free to contact
me with any questions.