Sperm Banking Background Fundamentals- Regulations

The following background information on sperm banking was prepared by and agreed upon by the leading companies in the industry. Its purpose is to provide basic information about some of the key elements of a sperm bank’s operations and influence, and to further understanding by providing accurate and consistent information.

Regulation: Sperm banking, which includes the screening and testing of sperm donors, is an increasingly regulated activity. Effective on May 25, 2005, the U.S. Food and Drug Administration (FDA) commenced its regulation of reproductive tissue banks (21 CFR Part 1271). The FDA’s regulatory focus includes standards for the screening and testing of donors and proper record keeping procedures. Since these regulations became effective, all major sperm banks have been audited for compliance by the FDA through on-site inspections. FDA inspections will be performed on a continuing basis.

In addition to federal regulation, most major sperm banks are also licensed and inspected by several states, particularly New York, California, and Maryland. Licensing by state agencies began as early as 1992.

Although not having the force of law, sperm banks also have conducted operations consistent with the guidelines and/or standards of professional organizations such as the American Society of Reproductive Medicine (ASRM) and the American Association of Tissue Banks (AATB).

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Notwithstanding the regulatory oversight of government agencies and professional associations, most sperm banks have exercised self-regulation consistent with the highest medical and ethical standards. In fact, most major sperm banks were performing more than all the tests required by the FDA several years prior to the FDA’s effective date, and with greater frequency than required by the FDA and other regulatory agencies.

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How to Choose a Sperm Donor

Blog written by Joseph D. Schulman, M.D. Founder, Genetics & IVF Institute

Choosing a sperm donor is a very important decision, and everyone brings their own perspectives to this challenge. With many years of experience caring for patients with problems in reproduction and medical genetics, I hope to help you reach the final donor decision that is right for you. I will also explain why only a small minority of men are able to meet the difficult requirements for being sperm donors at CLI.

It is essential to maximize safety from the risks of inadvertent transmission of an infectious disease. Only frozen donor sperm should be used, and then only if the sperm samples have been quarantined and the donor fully retested several months after the sperm was obtained to exclude infectious diseases. Using fresh sperm always carries some risk that the donor may have been exposed to HIV or other diseases so recently that it would not produce abnormalities on concurrent laboratory testing. From the inception of its donor sperm program in the 1980s, CLI has consistently provided only frozen, quarantined donor sperm which is cleared for sale only after the donor has had extensive initial infectious disease testing followed by retesting after a long quarantine period. You can have complete confidence that every dose of frozen sperm sold by CLI and its affiliates meets this rigorous safety standard.

Another important safety consideration is minimizing the risk of transmission of a genetic disease to the child. We have pioneered for many years in genetic disease prevention. Our Cryobank is the only major bank which has full-time medical geneticists and genetic counselors on its staff to carefully screen potential donors for any family history or clinical manifestations of genetic illnesses. Furthermore, all donor candidates undergo the most extensive battery of genetic tests of any sperm bank, and all results are reviewed by our own genetics professionals. While the risk of genetic disease transmission can never be completely excluded, you can be confident that acquiring sperm from CLI guarantees that this serious donor risk factor is reduced to the lowest level available anywhere.

There is much misunderstanding about the importance of inheritance in determining the kind of child which will result from the contribution of its biological father. Each egg and sperm contains half the genes of the respective parent, and thus the child shares half its genes with each parent – but only half. There is no way to determine which genetic attributes will be inherited by a specific individual until after conception, when in special cases genetic testing on the embryo, fetus, or child can provide useful information. Thus children to some extent resemble their parents, but the resemblance is far from complete. The genetic connection to siblings also involves sharing half of one’s genes. Siblings typically are far from identical in most characteristics – but they nevertheless tend to resemble one another more than would two randomly selected, unrelated people.

How much does genetic inheritance really matter in determining what kind of person one becomes? Optimizing the environment, broadly defined to include good nutrition, parental love, excellent educational opportunities, and more will of course help each child reach its full potential. But there is extensive evidence that this potential is heavily influenced by inheritance. The best proof comes from long-term studies of identical twins – who are genetically identical – but who have been separated near the time of birth and thereafter reared apart. A definitive summary of research on identical twins reared apart has recently been compiled by Nancy L. Segal, Ph.D., in her book “Born Together – Reared Apart: The Landmark Minnesota Twin Study”. The fundamental conclusion from decades of research is that the life patterns, accomplishments, intelligence, and appearance of identical twin pairs, who in many cases never met again until very advanced ages, are amazingly similar. So genetics matters a great deal in determining who we are and what we will become in childhood and adult life. Most scientists now recognize that intelligence is at least 50% determined by inheritance, and many would place that number closer to 70%. Such traits as musical ability, artistic talent, athletic aptitude, and many more are also partly genetic.

For this reason, we recommend that even allowing for the variability in inheritance of specific genes from biological parents, significant thought be given to choosing a sperm donor who has the qualities that one might like to see in one’s child. There is no guarantee that a specific quality will indeed be expressed in the child, but there is a greater likelihood of it occurring than if this is not factored into the decision about which donor to use. This is why our Cryobank donor pool is very carefully selected not only to exclude detectable propensities to adverse traits but very importantly to include positive attributes widely desired by many parents. We exclude donors with histories or evidence of alcohol or drug abuse, negative behavioral characteristics, manic depressive illness or schizophrenia, and potentially heritable physical limitations. We utilize donors who are college students or who may have advanced degrees (including doctoral degrees) providing evidence of substantial intelligence. Detailed information about the talents, interests, attributes, and appearance of our donors is available, and specific additional information is available to you upon request. Our goal is to ensure that you are able to choose from an exceptionally large number of sperm donors who are high quality people.

Lastly, it is important to note that the large majority of donor candidates who meet all the above standards for infectious and genetic safety and who have admirable characteristics are nevertheless rejected as donors at CLI. It is an unexplained biological fact that the sperm of most men does not freeze well. Thus while fresh sperm from most men easily initiates pregnancies, only a small minority produce sperm which can be frozen, stored, and thawed before use and still retain the exceptional viability and vitality needed to produce pregnancies at a high rate.

In the final analysis, when you choose sperm from one of our donors you are selecting among potential biological fathers who have been very, very carefully interviewed, screened, and tested to meet all the necessary requirements for being an outstanding sperm donor. Less than 1% of all donor applicants are successfully accepted as donors at CLI. We have found these donors through considerable effort based on an understanding of the strong importance of the various issues discussed in this article. We wish you good luck in your choice of the best donor for you.

CLI BlogWe are here to help, and if any additional information on any of our donors is important to you we shall do our utmost to provide it. Just call 800-466-2796. We are confident you will find what you need at Cryogenic Laboratories, Inc.

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What is Infertility?

From the American Society for Reproductive Medicine (ASRM) fact sheet on Defining Infertility.

What is infertility?

Infertility is “the inability to conceive after 12 months of unprotected intercourse.” This means that a couple is not able to become pregnant after a year of trying. However, for women aged 35 and older, inability to conceive after 6 months is generally considered infertility.

How common is it?

Infertility affects 10%-15% of couples. This makes it one of the most common diseases for people between the ages of 20 and 45. In addition, the longer a woman tries to get pregnant without conceiving, the lower are her chances to get pregnant without medical treatment. Most (85%) couples with normal fertility will conceive within a year of trying. If a couple doesn’t conceive in the first year, their chance of conceiving gets lower each month. This happens more quickly as the woman gets older.

What can cause infertility?

Age: A woman’s age can have a big effect on her ability to have a baby, especially as she enters her 30s and 40s. For a healthy woman in her 20s or early 30s, the chances of conceiving each month is 25%-30%. But by the time a woman is 40 years old, the chances are 10% or less.

Ovulation Problems

If a woman doesn’t ovulate (release an egg) about once a month, she may have trouble getting pregnant. Problems like polycystic ovary syndrome (PCOS), thyroid disease, and other hormonal disorders can affect ovulation and lead to infertility. Women who don’t have regular menstrual periods often don’t ovulate. Women who are overweight or underweight are more likely to have problems with ovulation than women of normal body weight. These women might want to see a doctor who specializes in fertility (reproductive endocrinologist) in the first year of trying to get pregnant.

Damaged or Blocked Fallopian Tubes

Fallopian tubes are the tubes attached to the uterus where the sperm and egg usually meet. Blocked or damaged tubes can cause infertility or ectopic pregnancy (pregnancy outside the uterus). The chances of having blocked tubes are higher in women who have or have had endometriosis, surgery in the pelvis, or sexually transmitted infections (like gonorrhea or chlamydia). Women who are concerned about the health of their tubes should discuss this with their doctor early in the process of trying to get pregnant.

CLI Blog smallASRM is an excellent resource for reproductive facts. Please check out their patient resources website at http://www.reproductivefacts.org/.

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FAQs about Specimen Freezing, Storing & Shipping

How are specimens stored?

All semen specimens are stored at -196o C in liquid nitrogen tanks equipped with automatic fill devices and alarm systems. CLI also provides liquid nitrogen transport tanks for shipping patient specimens to their physician or health care provider when requested for use.

How long can you store frozen sperm?

Cryopreserved specimens, when properly stored, will remain viable for an indefinite amount of time. Pregnancies have been reported for cases in which the sperm has been stored for 20 years prior to thawing and insemination.

Is the freezing process harmful to the sperm cells?

Approximately 50% or more of the sperm cells survive the freezing/thawing process. The fertilization capability of the surviving sperm cells is not jeopardized during the freezing/thawing process.

How are the sperm specimens shipped?

All of our specimens are shipped in liquid nitrogen vapor tanks via FedEx, local courier, or local patient pick up. The liquid nitrogen vapor tank is inside of a hard outer case for FedEx orders and a cardboard box for local orders.  The inner canister (vapor tank) is fastened using a cable tie to prevent tampering. Shipping papers are contained inside the outer case which contains a packing slip with the following information about your order: your health care provider’s name and address, your name and address, your donor number and specimen preparation, number of vials, and post thaw count and motility for each units. Also included are a summary of records detailing the donor testing and a statement of donor eligibility, specimen thawing instructions, return instructions and prepaid return labels.

Do you ship sperm specimens on dry ice?

No, Fairfax Cryobank stores all of its specimens in liquid nitrogen, which has a temperature of -196 degrees centigrade. Dry ice has a temperature of -78.5 degrees centigrade that is far below the temperature in which we store specimens and can result in a partial thaw process that is detrimental to the quality of the samples. For this reason CLI does not ship samples on dry ice.

How long are the specimens maintained frozen in the shipping tanks?

Our standard shipping tanks have a guarantee of 7 days. Upon request and for an additional fee we can send your specimens in a 2 week tank in which the vials are guaranteed frozen for 14 days.

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Guaranteed Availability: VIAL BUY & STORE

You find the donor you want now but are uncertain if his specimens will still be available when you need them. 

OR

You have one child by a CLI donor and would like to plan a second child by the same donor.

You can keep your fingers crossed and hope your donor will be available when you need him. The more prudent option is to buy doses ahead and store them at Cryogenic Laboratories. It guarantees your donor of choice is already put aside for you, and you won’t find yourself disappointed if he sells out. A donor can sell out at any time, so being prepared makes sense.

All semen specimens are stored in liquid nitrogen tanks equipped with automatic fill devices and alarm systems. CLI offers several different billing options, including monthly and more economical long-term storage agreements. Patients pay one fee  regardless of how many specimens they choose to store. Specimens in storage may be shipped to the health care provider of your choice for the current handling and shipping charges. They can also be shipped to your home if the appropriate home consent forms have been completed.

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What did you say?

Blog written by CLI Family Forum Moderator Desiree

After the last blog article about abbreviations, I came up with another list to help users navigate the technology lingo often found throughout the CLI Family Forums.

Here are a few common medical abbreviations used on the forum that are usually found in posts discussing inseminations or pregnancy testing.

AF: Aunt Flo – female menstrual cycle

OPK: Ovulation Predictor Kit

BBT: Basal Body Temperature – used to pinpoint when ovulation has occurred and determine future patterns for predicting ovulation

LH: Luteinizing Hormone – hormone that increases briefly just prior to ovulation

POAS: Pee On A Stick – in reference to taking a home pregnancy test

HPT: Home Pregnancy Test

hCG: Human Chorionic Gonadotropin – hormone produced by the body that pregnancy tests use to establish positive results

Beta: beta HCG levels are tested at a physician’s office to confirm pregnancy

BFP: Big Fat Positive – Pregnant

BFN: Big Fat Negative – Not Pregnant

IVF: In Vitro Fertilization

FET: Frozen Embryo Transfer

CLI BlogNow that you understand some of these abbreviations you can confidently join the discussions of the CLI Family Forums.

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Forum Abbreviations Explained

Blog written by CLI Family Forum Moderator Desiree

Technology has opened the world to a whole new form of communication. The CLI Family Forums offer the opportunity to connect with other people who have utilized donor sperm to start a family. This is a great resource for those who are just starting their insemination journey. However, the medical terminology can be overwhelming and the abbreviations used by forum members can make it even more confusing.

Here are a few of the most common abbreviations used in the forum discussion boards:

SMC: Single Mother by Choice

dh/dw/dd/ds/dp: a reference to members of one’s family such as dear husband, dear wife, dear daughter, dear son, dear partner

TTC: Trying To Conceive / Time To Conceive

BBT: Basal Body Temperature – used to pinpoint when ovulation has occurred and determine future patterns for predicting ovulation

RE: Reproductive Endocrinologist – a doctor that identifies and treats infertility

2WW/TWW: Two week wait – this is the time between the end of your fertility treatment cycle and the test that confirms pregnancy

HPT: Home Pregnancy Test

POAS: Pee On A Stick – in reference to taking a home pregnancy test

hCG: Human Chorionic Gonadotropin – hormone produced by the body that pregnancy tests use to establish positive results

BFP: Big Fat Positive – Pregnant

BFN: Big Fat Negative – Not Pregnant

PM: Private message – Electronic message similar to an e-mail but is viewed only through the forum

CLI BlogNow that you have learned some of the donor sperm lingo, check out the CLI Family Forums to put it to good use. It’s a fun way to interact with others online.

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Healthy Babies

Blog written by Director of Client Development Michael Buuck, MS

If you want to avoid an awkward an uncomfortable situation, do not congratulate a woman on her pregnancy until after she’s told you she is pregnant. Fortunately, I haven’t made that mistake but I have recently congratulated a friend on her pregnancy (after she told me she was pregnant).

One of the questions I asked her was if she would prefer to have a boy or girl. She said she didn’t care as much about the sex of the baby as long as he or she was healthy. Having a healthy baby is something all expectant mothers want and it’s also a desire for the many women who choose to become pregnant through the use of donor sperm. Women who elect to use donor sperm want to know that the donor they choose has been fully tested and screened, so they can increase their chances of having a healthy baby.

To assure that all donors are healthy, sperm banks have an extensive screening process which is intentionally designed to be rigorous and exclude any applicants that don’t meet the high standards and qualifications. This screening process involves a lengthy health questionnaire; physical exam; medical, genetic and infectious disease testing; a thorough sperm quality evaluation and several in-person interviews with staff. The process results in less than 1% of donor applicants being accepted as donors.

In the general population, every pregnancy has about a 3%-4% risk of producing a child with a birth defect or mental deficiency. The screening and testing of donors reduces that risk but cannot eliminate it. Sperm banks provide as much donor information as possible, so prospective mothers can make an informed choice. If someone tells me they are considering using donor sperm, I assure them that sperm banks are committed to providing donor sperm that produce healthy babies.

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Stress may hinder fertility chances

Blog written by CLI Family Forum Moderator Desiree

It is well known that excessive, chronic stress can negatively affect the health of our bodies. Deciding to start a family is a very big decision and life change for many people. It is only natural to start feeling some anxiety and increased tension after several unsuccessful tries to conceive a child. Some women on the CLI Family Forum discussion boards attribute their fertility struggles to overwhelming stress.

They claim as they reduced or eliminated stress they had a successful insemination. But it isn’t easy to calm your nerves when all you want is to have a happy, healthy family. So here are some suggestions from some women on the forum to help you reduce stress levels during this process:

  • Become educated on the insemination process. The extra research and knowledge will help you feel more in control of your situation and your choices.
  • Trust your intuition and your body. If something doesn’t feel right to you, discuss it with your doctor. Many women on the board ended up switching doctors because they weren’t comfortable with their first one.
  • Get a massage the day before your insemination. This is not only a great way to reduce extra muscle tension, but it also gives you some time to calm your mind and relax.
  • Some women on the forum utilized acupuncture to reduce stress and enhance fertility.
  • Fresh air is a must for good health and low stress. Go for a brisk walk outside and enjoy the outdoors.
  • Try your best to stay positive during the two week wait after your insemination until you know if it worked. This may be the longest two weeks of your life, so try to keep your mind focused on other activities.

CLI BlogVisit the CLI Family Forums to get encouragement from others who have gone through the same thing. Good luck on reducing your stress. Once you have your baby a whole new level of stress will develop. But that is for another post.

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So Many Options

Blog written by Laboratory Staff JM

These days, those who use donor sperm to conceive have more options than ever. The search tools for donor catalogs are extremely advanced, allowing a woman or couple to narrow down her ideal donor based on many characteristics: his physical attributes, his ancestry or education, whether or not he is Identity Option (ID Option), just to name a few.

I think exploring the reason why one donor is chosen over another is a very interesting topic. Did the couple choose that donor because he had black curly hair? Was the donor being ID Option the most important characteristic to the single woman who chose him? Is the fact that the donor is anonymous the most appealing thing about his profile, or is it his occupation or religious beliefs that make him the ideal donor for a particular woman or couple?

I often wonder what sort of expectations someone has when they choose a donor, beyond the obvious desire to conceive and have a baby. Does she (or they) plan to tell their child he or she was conceived using a sperm donor? Or if we flip the coin to the people who chose anonymous donors, do they plan to never disclose that information to their child (children)? Do they plan to use CLI Family Forums or the Donor Sibling Registry to connect with others who used the same donor? Would their ideal situation be to use an “exclusive” type donor who has been limited to maybe a couple of recipients?

These days, most cryobanks have advanced search tools that allow their clients many options to narrow down their donor selection. There are other resources available to families who have children who were donor-conceived, whether it be contacting the cryobank by email/phone/online chat, or social media. Further, donor families can connect via CLI Family Forums, the Donor Sibling Registry, and various other groups.

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