Question 1

What is the SDD Test?

Accepted Answer

The SDD Test is used to identify patients whose sperm are incapable of normal decondensation and, therefore, proper embryonic development.
 
Only commercially available in vitro sperm function test for evaluating a critical post-fertilization sperm activation event, i.e., decondensation of the sperm chromatin, in a controlled, physiologically relevant environment*
 
The SDD Test is one part of the Human Sperm Activation Assay (HSAA); an in vitro sperm function test that can evaluate sperm activation events including: decondensation, DNA synthesis, and recondensation1,2 Patent numbers: 5,358,847, 5,770,363, and 5,919,621 (+ 2 Patents Pending).

Question 2

FDA Donor Screen Quick Facts

Accepted Answer

• We do NOT pool samples.
 • We store all FDA donor specimens for 9 months.
 • Use only FDA-licensed test kits approved and cleared for donor screening.
 • Provide quarterly reports summarizing patient’s results to facilitate compliance with FDA regulations
 • Serve as an easily accessible resource for FDA inspections.
 • Immediate verbal confirmation of test results with the office in cases where a positive result is obtained.
 • Expedited testing at no extra cost for emergency cases where time is critical.
 • Offer web access to customized FDA donor test panels.
 • All requisitions carefully reviewed to ensure required donor tests have been properly ordered.
 • Offer rapid turn-around time, phlebotomy supplies and all costs related to shipping.

Question 3

What is the Male Reproductive Health (MRH) Panel?

Accepted Answer

The MRH panel is a group of diagnostic tests that analyze how genetically fit sperm DNA is to do its job of fertilizing an egg which results in the creation of an embryo. The DNA message that each sperm carries is essential in the process of creating an embryo since it is needed to combine with the DNA message in the egg. If there is a significant problem with a sperms DNA message, the result may be a failure in the first trimester of pregnancy or a pregnancy may not occur at all. 
 
Without some type of intervention or treatment, this condition will continue to keep the chances of having a baby through natural conception or reproductive therapy (IUI, IVF) below the normal success rate.

Question 4

What is the ZIKV Detect™ IgM Capture ELISA?

Accepted Answer

The ZIKV Detect™ IgM Capture ELISA is a laboratory test designed to detect proteins the human body makes to fight a Zika virus infection. These proteins, called antibodies, appear in the blood starting soon after the start of illness and last for up to 12 weeks. In some people, they are present for longer than 12 weeks. If the ZIKV Detect™ IgM Capture ELISA detects these antibodies, the test is positive. If the ZIKV Detect™ IgM Capture ELISA does not detect these antibodies, the test is negative. 
InBios International, Inc.

Question 5

Chlamydia/Gonorrhea Amplified DNA Assay

Accepted Answer

CPT: 87491, 87591
Specimen: Urine or Swab    
Collection: BD ProbeTec Urine Preservative Transport (UPT) or Swab                
Shipping: Ambient
Stability: UPT: Ambient - 30 days; Refrigerated - 30 days; Frozen - 2 months
               Swab: Ambient - 6 days; Refrigerated - 30 days; Frozen - Unacceptable
Method:  Strand Displacement Amplification (SDA)/ Fluorescent Energy Transfer (ET)  
 
Approved by FDA for Donor Screening License # K012351

Question 6

Adverse outcome:

Accepted Answer

A pregnancy that does not result in a live birth, including miscarriage, induced terminations, and stillbirths.

Question 7

Symptoms

Accepted Answer

Some of the symptoms of PCOS include:
 • Irregular menstrual cycle. Women with PCOS may miss periods or have fewer periods (fewer than eight in a year). Or, their periods may come every 21 days or more often. Some women with PCOS stop having menstrual periods.
 • Too much hair on the face, chin, or parts of the body where men usually have hair
 • Acne on the face, chest, and upper back
 • Thinning hair or hair loss on the scalp; male pattern baldness
 • Weight gain or dif culty losing weight
 • Darkening of skin, particularly along neck creases, in the groin, and underneath breasts
 • Skin tags, which are small aps of excess skin in the armpits or neck area 
 
Women with PCOS have three characteristic symptoms. Women are diagnosed with PCOS when they have at least two of these three symptoms:
1. Irregular periods
2. Excess androgens — either measured in the blood or seen through symptoms such as acne or excess hair growth
3. Polycystic ovaries — seen on ultrasound
Women with PCOS may have irregular periods. They may have only 6 to 8 periods per year. They may get their period every month for a few months and then skip a month or two or they may go many months without having a period. Many women with PCOS will have infertility associated with their irregular menses. Also, when women with PCOS do become pregnant, they have an increased rate of miscarriage.
​
Another common symptom of PCOS is acne or oily skin. Acne may occur over the face but may also be found over the back or chest. This is due to relatively higher levels of testosterone circulating in the bloodstream. Testosterone is a hormone that is found in much higher levels in men. Women with PCOS do not have male levels of testosterone but the levels of testosterone may be higher than expected for females. These higher levels of circulating testosterone can also cause excess facial hair on the chin or upper lip or excess hair growth on the chest and abdomen. The hormone imbalances seen in PCOS can also cause a type of hair thinning which occurs at the front of the scalp. Sometimes blood tests can show excess levels of testosterone in women with PCOS but other times they do not.
​
The third common feature of PCOS is what is called polycystic ovaries. This can be seen on a transvaginal ultrasound. This is actually a misnomer as the ovaries of women are not really full of cysts but rather ovarian follicles that each contains an egg. All women have these follicles in their ovaries and each month a group of follicles start to develop, with one going on to be the dominant follicle that ovulates the egg. The ovaries of women with PCOS may contain many small follicles that do not go on to ovulate an egg each month.These follicles fail to develop normally because of the hormonal imbalances in PCOS. Because the ovaries do not grow and ovulate an egg each month, women with PCOS may also experience difficulty getting pregnant.
​
Obesity is also common in women with PCOS. Up to 50-60% of women with PCOS are obese. Symptoms of PCOS such as those described above can be worsened by obesity. The hormonal imbalances found in women with PCOS may cause them to be more likely to gain weight and become obese. Women with PCOS are also prone to developing insulin resistance in which the body produces excess amounts of insulin. This is thought to be a precursor to Type II diabetes. Women with PCOS are at greater risk of developing diabetes and therefore all women with PCOS should be screened for insulin resistance.

Question 8

Symptoms

Accepted Answer

Some of the symptoms of PCOS include:
 
 • Irregular menstrual cycle. Women with PCOS may miss periods or have fewer periods (fewer than eight in a year). Or, their periods may come every 21 days or more often. Some women with PCOS stop having menstrual periods.
 • Too much hair on the face, chin, or parts of the body where men usually have hair
 • Acne on the face, chest, and upper back
 • Thinning hair or hair loss on the scalp; male pattern baldness
 • Weight gain or dif culty losing weight
 • Darkening of skin, particularly along neck creases, in the groin, and underneath breasts
 • Skin tags, which are small aps of excess skin in the armpits or neck area

Question 9

ABO Typing & RH Factor

Accepted Answer

CPT: 86900/86901
Specimen:  Whole Blood    
Collection:  Lavender (EDTA)                                      
Shipping:  Ambient
Stability:  Refrigerated - 14 days; Frozen - Unacceptable                              
Method:  Hemagglutination

Question 10

Should pregnant women travel to areas with risk of Zika?

Accepted Answer

No. Pregnant women should not travel to any area with risk of Zika. Travelers who go to places with risk of Zika can be infected with Zika, and Zika infection during pregnancy can cause microcephaly and other severe brain defects.

Question 11

Chlamydia/Gonorrhea Amplified DNA Assay

Accepted Answer

CPT: 87491, 87591
Specimen: Urine or Swab    
Collection: BD ProbeTec Urine Preservative Transport (UPT) or Swab                
Shipping: Ambient
Stability: UPT: Ambient - 30 days; Refrigerated - 30 days; Frozen - 2 months
               Swab: Ambient - 6 days; Refrigerated - 30 days; Frozen - Unacceptable
Method:  Strand Displacement Amplification (SDA)/ Fluorescent Energy Transfer (ET)  
 
Approved by FDA for Donor Screening License # K012351

Question 12

What Causes Infertility In Men?

Accepted Answer

The most common causes of male infertility are azoospermia (no sperm cells are produced) and oligospermia (few sperm cells are produced). Sometimes, sperm cells are malformed or they die before they can reach the egg. In rare cases, infertility in men is caused by a genetic disease such as cystic fibrosisor a chromosomal abnormality.

Question 13

Hepatitis B Core Antibody Total

Accepted Answer

CPT: 86704
Specimen: Serum    
Collection: Tiger SST                                  
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days 
Method: Enzyme-Linked Immunosorbent Assay
 
Approved by FDA for Donor Screening License #1236

Question 14

Antibody Screen RBC

Accepted Answer

CPT: 86850
Specimen:  Whole Blood    
Collection:  Lavender (EDTA)                                        
Shipping:  Ambient
Stability:  Refrigerated – 7 days
Method:  Solid phase antibody detection

Question 15

What Causes Infertility In Women?

Accepted Answer

The most common cause of female infertility is ovulation disorders.  Problems with ovulation affect about 25% of all infertility situations.  Other causes of female infertility include blocked fallopian tubes, which can happen when a woman has had pelvic inflammatory disease or endometriosis; Congenital anomalies (birth defects) involving the structure of the uterus, and uterine fibroids which are associated with repeated miscarriages; and aging, since the ability for ovaries to produce eggs tends to decline with age, especially after the age of 35.

Question 16

Diagnosis

Accepted Answer

Women with PCOS have three characteristic symptoms. Women are diagnosed with PCOS when they have at least two of these three symptoms:
1. Irregular periods
2. Excess androgens — either measured in the blood or seen through symptoms such as acne or excess hair growth
3. Polycystic ovaries — seen on ultrasound
Women with PCOS may have irregular periods. They may have only 6 to 8 periods per year. They may get their period every month for a few months and then skip a month or two or they may go many months without having a period. Many women with PCOS will have infertility associated with their irregular menses. Also, when women with PCOS do become pregnant, they have an increased rate of miscarriage.
​
Another common symptom of PCOS is acne or oily skin. Acne may occur over the face but may also be found over the back or chest. This is due to relatively higher levels of testosterone circulating in the bloodstream. Testosterone is a hormone that is found in much higher levels in men. Women with PCOS do not have male levels of testosterone but the levels of testosterone may be higher than expected for females. These higher levels of circulating testosterone can also cause excess facial hair on the chin or upper lip or excess hair growth on the chest and abdomen. The hormone imbalances seen in PCOS can also cause a type of hair thinning which occurs at the front of the scalp. Sometimes blood tests can show excess levels of testosterone in women with PCOS but other times they do not.
​
The third common feature of PCOS is what is called polycystic ovaries. This can be seen on a transvaginal ultrasound. This is actually a misnomer as the ovaries of women are not really full of cysts but rather ovarian follicles that each contains an egg. All women have these follicles in their ovaries and each month a group of follicles start to develop, with one going on to be the dominant follicle that ovulates the egg. The ovaries of women with PCOS may contain many small follicles that do not go on to ovulate an egg each month.These follicles fail to develop normally because of the hormonal imbalances in PCOS. Because the ovaries do not grow and ovulate an egg each month, women with PCOS may also experience difficulty getting pregnant.
​
Obesity is also common in women with PCOS. Up to 50-60% of women with PCOS are obese. Symptoms of PCOS such as those described above can be worsened by obesity. The hormonal imbalances found in women with PCOS may cause them to be more likely to gain weight and become obese. Women with PCOS are also prone to developing insulin resistance in which the body produces excess amounts of insulin. This is thought to be a precursor to Type II diabetes. Women with PCOS are at greater risk of developing diabetes and therefore all women with PCOS should be screened for insulin resistance.

Question 17

Why was my sample tested using the ZIKV Detect™ IgM Capture ELISA?

Accepted Answer

Your sample(s) were tested because you have signs and symptoms of Zika virus infection, because you live in or have recently traveled to a place where Zika virus infection is known to occur, and/or because you have another possible exposure to Zika virus. The sample(s) collected from you were tested using the ZIKV Detect™ IgM Capture ELISA to help find out whether you may have been infected with Zika virus.

Question 18

Out of Town Donor Testing

Accepted Answer

Many of our clients have had cases in which couples choose to use a donor from an agency or have a specific person (relative, friend) in mind. In some cases this can make the entire process more challenging when the donor does not reside within a reasonable driving distance of the IVF clinic. The only options at this point are to send them to the most convenient lab that can draw blood and run the tests or fly the donor in for testing. The first option has limited appeal because it would cause the IVF clinic performing the procedure to potentially use a lab other than the one they have been for their donor testing. This introduces potential variables that can make maintaining full FDA compliance difficult at best. The option of flying the donor in increases the cost for the entire procedure for the recipient couple.
 
We have developed a service to maintain the consistency of donor testing and FDA compliance for the IVF clinic while minimizing the additional cost of airfare. The solution is our Out of Town Donor Testing Service. With this service the consistency and quality of our FDA donor testing can be done without additional cost.

Question 19

What Tests Make Up the Male Reproductive Health (MRH) Panel?

Accepted Answer

1. Sperm DNA Accelerated Decondensation (SDAD) Test: Measures Accelerated Sperm DNA Decondensation (Sperm Head Swelling)
2. Sperm DNA Decondensation (SDD) Test: Measures Delay in Sperm DNA Decondensation (Sperm Head Swelling)          
3. Sperm Chromatin Fragmentation Assay (SCFA): Measures Fragmented Sperm DNA:  Compromised DNA Integrity & Measures Immature Sperm

Question 20

Causes

Accepted Answer

The exact cause of PCOS is not known. Most experts think that several factors, including genetics, play a role:
 • High levels of androgens. Higher than normal androgen levels in women can prevent the ovaries from releasing an egg (ovulation) during each menstrual cycle, and can cause extra hair growth and acne.
 • High levels of insulin. Insulin is a hormone that controls how the food you eat is changed into energy. Insulin resistance is when the body’s cells do not respond normally to insulin. As a result, your insulin blood levels become higher than normal. Many women with PCOS have insulin resistance, especially those who are overweight or obese, have unhealthy eating habits, do not get enough physical activity, and have a family history of diabetes (usually type 2 diabetes). Over time, insulin resistance can lead to type 2 diabetes.

Question 21

Hepatitis B Core Antibody Total

Accepted Answer

CPT: 86704
Specimen:  Serum    
Collection:  Tiger SST                                  
Shipping:  Ambient
Stability:  Refrigerated – 7 days; Frozen – Longer than 7 days 
Method:  Enzyme-Linked Immunosorbent Assay
 
Approved by FDA for Donor Screening License #1236

Question 22

ART (Assisted Reproductive Technology):

Accepted Answer

Any procedure where eggs are surgically removed from a womanâ€™s ovaries and combined with sperm to assist a woman in getting pregnant. ART procedures include in vitro fertilization (IVF), gamete intrafallopian transfer(GIFT), and zygote intrafallopian transfer (ZIFT).

Question 23

Chlamydia trachomatis/Neisseria gonorrhea Amplified DNA Assay

Accepted Answer

CPT: 87491, 87591
Specimen: Urine or Swab
Collection: BD ProbeTec Urine Preservative Transport (UPT) or Swab
Shipping: Ambient
Stability: UPT: Ambient - 30 days; Refrigerated - 30 days; Frozen - 2 months
              Swab: Ambient - 6 days; Refrigerated - 30 days; Frozen - Unacceptable
Method: Strand Displacement Amplification (SDA)/ Fluorescent Energy Transfer (ET)
 
Approved by FDA for Donor Screening License # K012351

Question 24

If I am traveling to an area with risk of Zika, should I be concerned about Zika?"

Accepted Answer

Travelers who go to places with risk of Zika can be infected with Zika, and CDC has issued travel recommendations for people traveling to areas with a CDC Zika Travel Notice. Many people will have mild or no symptoms. However, Zika can cause microcephaly and other severe birth defects. For this reason, pregnant women should not travel to any area with risk of Zika, and women trying to get pregnant should talk to their doctors before traveling or before their sex partners travel to an area with risk of Zika. It is especially important that women who wish to delay or avoid pregnancy consistently use the most effective method of birth control that they are able to use. Those traveling to areas with risk of Zika should take steps during and after they travel to prevent mosquito bites and sexual transmission of Zika.

Question 25

What Can the SDD Test Do For Your Clinic?

Accepted Answer

Improve your clinic’s live birth rates for IUI, IVF and ICSI

Question 26

Causes

Accepted Answer

The exact cause of PCOS is not known. Most experts think that several factors, including genetics, play a role:
 
 • High levels of androgens. Higher than normal androgen levels in women can prevent the ovaries from releasing an egg (ovulation) during each menstrual cycle, and can cause extra hair growth and acne.
 • High levels of insulin. Insulin is a hormone that controls how the food you eat is changed into energy. Insulin resistance is when the bodyâ€™s cells do not respond normally to insulin. As a result, your insulin blood levels become higher than normal. Many women with PCOS have insulin resistance, especially those who are overweight or obese, have unhealthy eating habits, do not get enough physical activity, and have a family history of diabetes (usually type 2 diabetes). Over time, insulin resistance can lead to type 2 diabetes.

Question 27

What is the single most important hormone level to be tested in the evaluation of infertile men?

Accepted Answer

FSH is the most important hormone level. FSH indirectly relates to sperm concentration and therefore can be helpful in determining whether lack of sperm production or obstruction is responsible for a low sperm concentration.

Question 28

Who Should Be Tested?

Accepted Answer

1. All males Pre-ART
2. Males with a varicocele(s)
3. Males with known exposure to reproductive toxicants
4. The male member of all couples experiencing recurrent pregnancy loss in the first trimester.
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Question 29

What are the symptoms of Zika virus disease?

Accepted Answer

The most common symptoms of Zika virus disease are fever, rash, headache, joint pain, red eyes, and muscle pain. Many people infected with Zika won’t have symptoms or will have mild symptoms, which can last for several days to a week.

Question 30

Blood Chromosome Analysis

Accepted Answer

CPT: 88262, 88230, 88291
Specimen: Whole Blood   
Collection:  Green (sodium heparin)                                                       
Shipping:  Ambient
Stability:  Refrigerated – 48 hours
Method:  Giemsa-Band

Question 31

Hepatitis B Core Antibody Total

Accepted Answer

CPT: 86704
Specimen: Serum
Collection: Tiger SST
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days
Method: Enzyme-Linked Immunosorbent Assay
Approved by FDA for Donor Screening License #1236

Question 32

What are the known and potential risks and benefits of the ZIKV Detect™ IgM Capture ELISA?

Accepted Answer

Besides possible discomfort or other complications that can happen when your sample(s) are collected, there is a risk that the test result is incorrect (see below for more information). The benefit of having this test is that the results of this test, along with other information, can help inform your healthcare providers when making recommendations about your care and, if you are pregnant, the care of your developing fetus. The results of this test may help limit the spread of Zika virus in your community. For more information, see.(http://www.cdc.gov/zika/prevention/protect-yourself-and-others.html)

Question 33

Treatment

Accepted Answer

There is no cure for PCOS, but you can manage the symptoms of PCOS.
 
You and your doctor will work on a treatment plan based on your symptoms, your plans for children, and your risk for long-term health problems such as diabetes and heart disease. Many women will need a combination of treatments, including:
 
Weight loss. Losing weight may help to lower your blood glucose levels, improve the way your body uses insulin, and help your hormones reach normal levels. Even a 10 percent loss in body weight (for example, a 150-pound woman losing 15 pounds) can help make your menstrual cycle more regular and improve your chances of getting pregnant.
​
Hair removal or slowing hair growth. You can try facial hair removal creams, laser hair removal, or electrolysis to remove excess hair. A prescription skin treatment (e ornithine HCl cream) can slow down the growth rate of new hair in unwanted places. 
Prescription medicines. Your doctor may prescribe hormonal birth control, such as the pill, patch, shot, vaginal ring, or hormonal intrauterine device (IUD), to improve acne and reduce unwanted hair. Other medicines can block the effect of androgens or lower insulin and androgen levels. If you are trying to get pregnant, your doctor may prescribe medicine to help you ovulate, such as clomiphene (Clomid).
In vitro fertilization (IVF). In IVF, your egg is fertil- ized with your partner’s sperm in a laboratory and then placed in your uterus to implant and develop. Compared with medicine alone, IVF results in higher pregnancy rates and lowers your risk for twins and triplets (by allowing your doctor to transfer a single fertilized egg into your uterus).
Surgery. The outer shell (called the cortex) of ova- ries is thickened in women with PCOS and thought to play a role in preventing spontaneous ovulation. Ovarian drilling is a surgery in which the doctor makes a few holes in the surface of your ovary using lasers or a ne needle heated with electricity. Surgery usually restores ovulation, but only for six to eight months.

Question 34

What Can the SDD Test Do For Your Patients?

Accepted Answer

With better direction in treatment, patients will bring babies home sooner and suffer less emotionally and financially.

Question 35

ART cycle:

Accepted Answer

The process includes 1) an ART procedure, 2) ovarian stimulation, or 3) frozen embryos thawed for transfer into a woman. This process begins when a woman starts fertility medications or has her ovaries monitored for follicle production.

Question 36

Hepatitis B Surface Antigen

Accepted Answer

CPT: 86704
Specimen: Serum    
Collection: Tiger SST                                  
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days 
Method: Enzyme-Linked Immunosorbent Assay
 
Approved by FDA for Donor Screening License #1236

Question 37

Hepatitis B Surface Antigen

Accepted Answer

CPT: 87340
Specimen: Serum
Collection: Tiger SST                                           
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days 
Method: Enzyme-Linked Immunosorbent Assay
 
Approved by FDA for Donor Screening License #1109

Question 38

The IVF clinic responsible for testing, the donor and the drawing physician’s office or draw station need to follow these simple steps:"

Accepted Answer

1. IVF clinic for recipient couple fills out & faxes an Out of Town Donor Test order form.
2. We then send out a complete donor kit with all necessary supplies, shipping materials and instructions to the donor.
3. The donor then takes the kit to a physician’s office (typically the IVF clinic that will be doing the hormone monitoring is used since they are very familiar with the whole procedure) or a draw station.
4. All specimens are collected, packaged up and shipped back to Unilab for testing.

Question 39

If this test is positive for Zika virus, does it mean that I have Zika virus infection?"

Accepted Answer

If you have a positive result, it is likely that you have had a recent Zika virus infection. It is possible that you may have had a recent Zika virus infection and not have any symptoms. There is a chance that this test can give a positive result that is wrong; this is called a “false positive” result. There are some other very closely related viruses (such as dengue virus) that can cause the human body to produce antibodies that may cause the test to be positive. 
​
If your result from this test is positive, your healthcare provider or health department will determine if your results should be evaluated with additional testing and/or with testing from other samples that may have been collected from you. It is important that you work with your healthcare provider or health department to help you understand the next steps you should take and, if you are pregnant, to monitor the health and development of your fetus. 
​
If you have a pregnant partner and you are positive for Zika virus infection, you should use condoms and/or other barriers (e.g., dental dams) consistently and correctly during sex, or abstain from sex with your partner, for the duration of the pregnancy, to lessen the risk that you may pass Zika virus infection to your partner. If you have a positive test result for Zika virus and you are considering becoming pregnant or have a partner who might become pregnant, then you should discuss risks with your healthcare provider.

Question 40

How is Zika diagnosed?

Accepted Answer

To diagnose Zika, your doctor will ask you about recent travel and symptoms you may have, and collect blood or urine to test for Zika or similar viruses.

Question 41

Hepatitis C Antibody (HCV)

Accepted Answer

CPT: 86803
Specimen: Serum   
Collection: Tiger SST                                                      
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days
Method: Enzyme-Linked Immunosorbent Assay
Approved by FDA for Donor Screening License #1236

Question 42

Sperm DNA Accelerated Decondensation (SDAD) Test and Sperm DNA Decondensation (SDD) Test Explained

Accepted Answer

Once a sperm has fertilized an egg, the DNA message must go through a transformational process in order for it to successfully combine with the eggs DNA message. The first step in this process is called decondensation. 
 
These tests assess whether or not the sperm DNA goes through normal decondensation process. Failure to go through the normal process may result in a partially or completely unreadable DNA message. leading to an increased chance of early pregnancy termination, or no pregnancy at all.

Question 43

Hepatitis B Surface Antigen

Accepted Answer

CPT: 87340
Specimen: Serum
Collection: Tiger SST
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days
Method: Enzyme-Linked Immunosorbent Assay
 
Approved by FDA for Donor Screening License #1109

Question 44

What hormones should be tested in males? When should hormonal testing be performed? Why?

Accepted Answer

Hormonal testing for infertile males consists of testosterone and FSH. However men with sperm counts greater than 10 million/mL rarely have significant hormonal abnormalities and Testosterone levels are unlikely to be of any benefit. FSH values can be predictive for the outcome of any type of fertility treatment, including hormonal manipulation and/or varicocele repair. Therefore, FSH determinations may be beneficial in all men before undergoing any therapy, but testosterone determination probably should be reserved for men who have severe oligoasthenospermia and/or signs of hypogonadism including small testicular size. In the case of a low testosterone level, it is important to look at other hormones that may affect testosterone production, including prolactin, estradiol, LH and FSH. These hormones are typically best measured early in the morning.

Question 45

Treatment & Effectiveness

Accepted Answer

There are treatments available for women with PCOS. These treatments do not cure the disease but rather help improve the symptoms of PCOS. For women with PCOS who are obese, diet and exercise to maintain a normal body weight may alleviate many of the symptoms of PCOS. 
 
In fact, for obese women, losing even 5-10% of body weight may help. Oral contraceptive pills are often given to correct some of the hormonal imbalances found in PCOS and can help decrease acne and excess hair growth as well as regulate menstrual cycles. Acne can also be treated with topical ointments or antibiotic creams. Women with excess hair growth often find laser electrolysis helpful. Metformin is an oral medication that may be prescribed to women with PCOS who are insulin resistant.
​
Women who are having difficulties conceiving may take a medication called clomiphene citrate or clomid to help them ovulate regularly. In women with PCOS who take clomid, about 80% will ovulate in response to the medication and 30-40% will become pregnant. About half of women will ovulate when taking one pill a day (50 mg) on cycle days five through nine. The other 50% of women do not ovulate on this dose of clomid and may need a higher dose or another medication. Using clomid increases your chances of having a multiple pregnancy to 8-13%, with twins being the most common. If pregnancy does not occur after six cycles of clomid use, further evaluation or a change in therapy is recommended.
​​
If you think you may be experiencing any or all of the symptoms of PCOS, it is important to see a doctor for diagnosis and treatment.

Question 46

Hepatitis C Antibody (HCV)

Accepted Answer

CPT: 86803
Specimen: Serum   
Collection: Tiger SST                                                      
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days
Method: Enzyme-Linked Immunosorbent Assay
Approved by FDA for Donor Screening License #1236

Question 47

Canceled cycle:

Accepted Answer

An ART cycle in which ovarian stimulation was carried out but was stopped before eggs were retrieved, or in the case of frozen embryo cycles, before embryos were transferred. The reasons a cycle may be have been cancelled include: undeveloped eggs, patient became ill, or the patient chose to stop treatment.

Question 48

Drug Screen, Urine"

Accepted Answer

CPT: 80301
Specimen:  Urine
Collection:  Urine Cup                                     
Shipping:  Ambient
Stability:  Refrigerated – 2 days; Frozen – Longer than 2 days
Method:  Chromatographic immunoassay

Question 49

Treatment

Accepted Answer

There is no cure for PCOS, but you can manage the symptoms of PCOS.

You and your doctor will work on a treatment plan based on your symptoms, your plans for children, and your risk for long-term health problems such as diabetes and heart disease. Many women will need a combination of treatments, including:Weight loss. Losing weight may help to lower your blood glucose levels, improve the way your body uses insulin, and help your hormones reach normal levels. Even a 10 percent loss in body weight (for example, a 150-pound woman losing 15 pounds) can help make your menstrual cycle more regular and improve your chances of getting pregnant.

Hair removal or slowing hair growth. You can try facial hair removal creams, laser hair removal, or electrolysis to remove excess hair. A prescription skin treatment (e ornithine HCl cream) can slow down the growth rate of new hair in unwanted places. 
 
Prescription medicines. Your doctor may prescribe hormonal birth control, such as the pill, patch, shot, vaginal ring, or hormonal intrauterine device (IUD), to improve acne and reduce unwanted hair. Other medicines can block the effect of androgens or lower insulin and androgen levels. If you are trying to get pregnant, your doctor may prescribe medicine to help you ovulate, such as clomiphene (Clomid).
In vitro fertilization (IVF). In IVF, your egg is fertil- ized with your partnerâ€™s sperm in a laboratory and then placed in your uterus to implant and develop. Compared with medicine alone, IVF results in higher pregnancy rates and lowers your risk for twins and triplets (by allowing your doctor to transfer a single fertilized egg into your uterus).
Surgery. The outer shell (called the cortex) of ova- ries is thickened in women with PCOS and thought to play a role in preventing spontaneous ovulation. Ovarian drilling is a surgery in which the doctor makes a few holes in the surface of your ovary using lasers or a ne needle heated with electricity. Surgery usually restores ovulation, but only for six to eight months.

Question 50

Hepatitis C Antibody

Accepted Answer

CPT: 86803
Specimen: Serum
Collection: Tiger SST
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days
Method: Enzyme-Linked Immunosorbent Assay
 
Approved by FDA for Donor Screening License #1236

Question 51

Combination cycle:

Question 52

Sperm Chromatin Fragmentation Assay (SCFA) Test Explained

Question 53

HIV I/II+O Antibody Screen

Question 54

My doctor believes that I might have an immune disorder that is causing my infertility. What are the most common tests to diagnose this problem?

Question 55

If I am pregnant and my test is positive for Zika virus, does it mean that my child will have a birth defect?"

Question 56

Nicotine Screen, Urine"

Question 57

Effectiveness of Treatments

Question 58

What should pregnant women who have recently traveled to an area with risk of Zika do?

Question 59

HIV I/II+O Antibody Screen

Question 60

If this test is positive for “other flavivirus” (e.g., dengue virus or West Nile virus), does it mean that I have dengue virus infection or West Nile virus infection? "

Question 61

HIV 1/2+O Antibody Screen

Question 62

Cystic Fibrosis (165 Pathogenic Variants)

Question 63

RPR

Question 64

How Does The Outcome of the Tests That Make Up The Male Reproductive Health Panel (MRH) Help Your Physician Help You?

FDA Donor Screen: Test Panels & Directory

What is the SDD Test?

FDA Donor Screen Quick Facts

What is the Male Reproductive Health (MRH) Panel?

What is the ZIKV Detect™ IgM Capture ELISA?

Chlamydia/Gonorrhea Amplified DNA Assay

Adverse outcome:

Symptoms

Symptoms

ABO Typing &amp; RH Factor

Should pregnant women travel to areas with risk of Zika?

Chlamydia/Gonorrhea Amplified DNA Assay

What Causes Infertility In Men?

Hepatitis B Core Antibody Total

Antibody Screen RBC

What Causes Infertility In Women?

Diagnosis

Why was my sample tested using the ZIKV Detect™ IgM Capture ELISA?

Out of Town Donor Testing

What Tests Make Up the Male Reproductive Health (MRH) Panel?

Causes

Hepatitis B Core Antibody Total

ART (Assisted Reproductive Technology):

Chlamydia trachomatis/Neisseria gonorrhea Amplified DNA Assay

If I am traveling to an area with risk of Zika, should I be concerned about Zika?"

What Can the SDD Test Do For Your Clinic?

Causes

What is the single most important hormone level to be tested in the evaluation of infertile men?

Who Should Be Tested?

What are the symptoms of Zika virus disease?

Blood Chromosome Analysis

Hepatitis B Core Antibody Total

What are the known and potential risks and benefits of the ZIKV Detect™ IgM Capture ELISA?

Treatment

What Can the SDD Test Do For Your Patients?

ART cycle:

Hepatitis B Surface Antigen

Hepatitis B Surface Antigen

The IVF clinic responsible for testing, the donor and the drawing physician’s office or draw station need to follow these simple steps:"

If this test is positive for Zika virus, does it mean that I have Zika virus infection?"

How is Zika diagnosed?

Hepatitis C Antibody (HCV)

Sperm DNA Accelerated Decondensation (SDAD) Test and Sperm DNA Decondensation (SDD) Test Explained

Hepatitis B Surface Antigen

What hormones should be tested in males? When should hormonal testing be performed? Why?

Treatment &amp; Effectiveness

Hepatitis C Antibody (HCV)

Canceled cycle:

Drug Screen, Urine"

Treatment

Hepatitis C Antibody

Combination cycle:

Sperm Chromatin Fragmentation Assay (SCFA) Test Explained

HIV I/II+O Antibody Screen

My doctor believes that I might have an immune disorder that is causing my infertility. What are the most common tests to diagnose this problem?

If I am pregnant and my test is positive for Zika virus, does it mean that my child will have a birth defect?"

Nicotine Screen, Urine"

Effectiveness of Treatments

What should pregnant women who have recently traveled to an area with risk of Zika do?

HIV I/II+O Antibody Screen

If this test is positive for “other flavivirus” (e.g., dengue virus or West Nile virus), does it mean that I have dengue virus infection or West Nile virus infection? "

HIV 1/2+O Antibody Screen

Cystic Fibrosis (165 Pathogenic Variants)

RPR

How Does The Outcome of the Tests That Make Up The Male Reproductive Health Panel (MRH) Help Your Physician Help You?

What is male factor infertility?

RPR

Concentration of motile sperm:

I am not pregnant, but will my future pregnancies be at risk if I am infected with Zika virus?"

RPR

What factors can impact my fertility?

Mycoplasma/Ureaplasma Culture

I was in a place with risk of Zika recently. How long do I need to wait after returning to get pregnant?

If this test is negative, does it mean that I do not have Zika virus infection? "

MPX: HBV/HIV/HCV

MPX: HBV/HIV/HCV

Cryopreservation:

Additional follow-up treatments for Abnormal MRH Panel Results may include:

MPX (HIV/HCV/HBV)

WNV

ABO Typing & RH Factor

Treatment & Effectiveness