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Volume 1 Issue 5 October 2005

The FDA is here to stay...
are you ready?

By Wendy D. Latash, Ph.D.

The 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.

With 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.

Finally, 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.

If 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.

We 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!

Wendy D. Latash, Ph.D.
Jade Tree Solutions, LLC

Cryo Eggs
The New Face of Infertility Treatment?
By Heather Zimmerman

Recently, 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 now?”

Oocyte 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 their fertility.

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: 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.

Heather Zimmerman
The Donor Source

The 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 and I will see that they are posted in the month you specify. All announcements must be in by the 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.

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Total Active Donors 273
New Donors 9
Repeat Donors 49
Asian Donors 29
Black Donors 16
East Indian Donors 3
Hispanic Donors 48
Jewish Donors 14
Middle Eastern Donors 10
White Donors 202

Reasons for selection: I have a few very loving and caring friends that actively help people everyday, I would only want to send them to a place that is warm and loving and would help them in their goal to help others and I feel this would be the right place.

- B.D. Anonymous Donor

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October 15, 2005
Santa Monica
ASRM Annual Conference:
October 15-19, 2005
Event Details
National Infertility
Awareness Week:
October 23-29, 2005
Event Details
Coastal Fertility Medical Center's
14th Annual Halloween Reunion
October 30, 2005
Event Details
ART and the FDA
Is your practice ready?
Los Angeles - Nov. 9, 2005
San Francisco - Nov. 10, 2005
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Contact Information

Director of Business Development:
Gail Sexton Anderson

Administrative Office
4675 MacArthur Court. Suite 490
Newport Beach, CA 92660
Phone: 877.375.8888
Fax: 877.835.2401

Northwest Office
PMB 4054
800 Bellevue Way NE #400
Bellevue, WA 98004
Phone/Fax: 888.668.0744


Director of Case Management:
Catherine Pateman
877.375.8888 ext 304
Orange County, San Diego &
Out of State Matches except Northwest

Case Managers:
Heather Zimmerman
877.375.8888 ext 303
Los Angeles

Erica Avedano
877.375.8888 ext 305
Northern California

Jennifer Hobodides
WA, OR, ID, MT, NM, NV, CO and AZ

Copyright ©2005 The Donor Source. All Rights Reserved. 
Subscriptions are FREE. While Fertility SOURCE Companies staff use their best efforts in collecting and preparing the information published herein, Fertility SOURCE Companies does not assume, and hereby disclaims, any liability for any loss or damage caused by using the contents of this newsletter, or from any errors or omissions, whether such errors or omissions resulted from negligence, accident or other causes. You may freely distribute Fertility SOURCE Companies "The SOURCE" material, as long as it bears the following attribution: Source: Fertility SOURCE Companies Fertility SOURCE Companies is published by The Donor SOURCE International, LLC. Material referenced by URL is the copyright of the respective owner.
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