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Volume 1 Issue 7 December 2005

Look to New Beginnings
By Gail Sexton Anderson

Couples wrestling with infertility are likely to find the holiday season anything but joyful. Now is the time to look to new beginnings. The new year is a great time to take the first steps toward a donor cycle.

You may have been thinking about going forward with a donor cycle but needed more time to adjust to the idea. Not many couples dive into a donor cycle fearlessly when their reproductive endocrinologist first suggests this avenue of treatment. But life is comprised of seasons and is the new year may be a good time to move on in treatment.

You may now be at the point where a donor ivf cycle seems like an attractive opportunity to be pregnant and give birth to chance to build your family. It might have seemed unthinkable six months or a year ago but now, as the new year awaits, this could be the most exciting opportunity of your lives. Many couples have made that leap and are delighted to be enjoying their children this Christmas.

Kim and Jason had been through every fertility treatment available. Kim was at the end of her rope: she hated every doctor in the greater Los Angeles area but decided to try one more IVF program with a donor egg. In the beginning, she had her doubts about this new group of doctors too, but with Jason’s support, she gave donor IVF a chance. Along the way Kim and I had many conversations; some good but mostly bad. Kim didn’t trust anyone at this point in her treatment. She had been disappointed too many times. But, with lots of encouragement from, the doctors, nurses, her husband and The Donor Source, Kim’s efforts to conceive were successful. She now has beautiful twin girls that are her heart’s delight. Kim changed overnight from a women struggling with despair to an advocate for egg donation. In my last conversation with Kim, she shed tears of joy. She can now leave the anger and pain behind her. In fact, she and Jason are considering a frozen cycle in the spring to broaden their beautiful family.

Donor cycles can have their ups and downs, but I have found that many couples trust in a higher power and do their best to maintain a sense of humor. If a donor should prove to be an ineligible donor for some unforeseen reason, the couple often finds a new donor who they feel a deeper connection with and end up feeling that their second donor is the one they were destined to cycle with. Liz and Eric were head over heels for Heather. She looked so much like Liz they couldn’t wait to start the cycle. When the agency where Heather was registered informed Liz and Eric that Heather was getting married and didn’t want to do another cycle, they were devastated.

I worked with them for weeks to find a new donor even though it took Liz a long time to let go of the fantasy she had built in her mind of what this future child would be like if she worked with Heather. She pleaded with the agency to beg Heather to reconsider but, it was not to be.

In time, Liz came to realize that, although Heather looked a great deal like her, one of our donors was more similar to Liz in her personality. Liz loved what Ali had to say about her life goals: Their likes and dreams mirrored each other far more closely than Heather. Liz went forward with Ali and is thrilled this holiday season to be celebrating their first Christmas with baby Austin who, by the way, looks just like his dad.

I encourage you this holiday season to look forward, not back. The donors I’ve mentioned gave a little of themselves so that the couples could experience the joy that children bring. This holiday season, spend time looking outside yourselves, realizing the blessings you have as you give to others. Do something outside your comfort zone; spend time in a homeless shelter or soup kitchen. Gather needed items and deliver them to Katrina victims. As hard as it may be to turn your focus outward during a frustrating and difficult season in your life, it may be the best way for you to get through the holidays. Then, look ahead as the new year dawns and you plan for a brighter future.

Gail Sexton Anderson
The Donor Source

www.thedonorsource.com

Wrap-up of the FDA seminars
By Wendy D. Latash, Ph.D.

As many of our readers know, The Donor Source, along with the Apothecary Shops of Arizona and Ferring Pharmaceuticals, hosted seminars this past month on “The FDA Regulations: Is Your Practice Ready?” The seminars were presented on November 9th in Long Beach and November 10th in San Francisco by Wendy Latash, PhD, Director of Advisory Services for Jade Tree Solutions. Attendees told us the information was valuable and useful for their specific situations.

We would also like to thank those who were able to attend the seminars—you made them a resounding success!

For those who were not able to attend and as a final reminder for those that did, we asked Dr. Latash to write a synopsis of what happened at the seminars as well as what kinds of questions were asked.

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The Seminars: a synopsis

Both seminars were well attended with various people including: physicians, nurses, embryologists, office staff, pharmaceutical representatives, donor agency personnel . . . and even a lawyer or two! The first hour was taken up by dinner and a presentation concerning the FDA regulations including the following topics:

  • Scope and implications for fertility practices
  • Subpart C: Donor Eligibility Requirements
  • FDA compliance in practice:
    • What does it mean to be “compliant”?
    • Basic areas to cover for fertility practices
  • FDA inspections:
    • When and how they occur
    • Tips on dealing with an FDA inspection
    • What the FDA inspectors are doing now

Much of the beginning dealt with an overview of why the regulations are important, who they affect, and specifics concerning how the regulations affect fertility practices currently. This part of the presentation about donor eligibility requirements broke out the different sections of donor eligibility requirements including information on: screening and testing practices, donor eligibility determination, recordkeeping and how the regulations affect the laboratory.

The next sections were about the kind of practical solutions that affected establishments can put into practice to become FDA compliant, as well as what to do during an FDA inspection. There was also information on what the inspectors are doing now (as of Nov 8th) to give people an idea of where to concentrate their compliance efforts.

After the presentation, an hour-long question and answer period followed—which seemed to be very helpful for the participants. Some of the types of questions people asked were about:

  • Anonymous donors: who is “eligible” and who isn’t?
  • Directed (known) egg, sperm or embryo donors—what documentation is needed if they are “ineligible”?
  • Gestational carriers—what happens when donors are “ineligible”?
  • How do we deal with CMV positive donors?
  • What appropriate records must accompany reproductive tissue?
  • What tests must be used?
  • What is the “window” for screening & testing donors?
  • How do we handle international donors?
  • How do we label the tissue properly?
  • What happens when we have a departure from procedure?

These represented most of the common types of questions asked, however there were also many specific questions about certain situations. There were some questions that could not be answered mainly because the FDA has not communicated that information to the fertility industry. As time goes on, we hope to see more of those questions being answered as:

  • The “Final Guidance for Industry” concerning donor eligibility is published;
  • More feedback about how FDA inspections are proceeding becomes known; and
  • We find out for what exactly the FDA is citing fertility establishments.

Finally, as a personal note, I would like to thank all the participants who came to the seminars as well as the sponsors. Your questions and the situations you presented are as helpful to me as I hope the information I presented was to you. Thanks again, and I wish you the best of luck in your pursuit of FDA compliance.

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

www.jadetreesolutions.com

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

Northern California Office
1750 Montgomery Street
1st Floor
San Francisco, CA 94111
Phone: 877.375.8888

email: info@TheDonorSource.com

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

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 http://www.fertilitySOURCEcompanies.com. 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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