FDA Donor Screen Tests & Panel Directory

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).

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.

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.

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.

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

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:

Irregular periods
Excess androgens — either measured in the blood or seen through symptoms such as acne or excess hair growth
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.

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

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

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.

Women with PCOS have three characteristic symptoms. Women are diagnosed with PCOS when they have at least two of these three symptoms:

Irregular periods
Excess androgens — either measured in the blood or seen through symptoms such as acne or excess hair growth
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.

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.

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.

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.

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

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.

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.

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.

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.

IVF clinic for recipient couple fills out & faxes an Out of Town Donor Test order form.
We then send out a complete donor kit with all necessary supplies, shipping materials and instructions to the donor.
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.
All specimens are collected, packaged up and shipped back to Unilab for testing.

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.

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.

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.

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.

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.

Antithyroglobulin Antibodies (ATA) can cause problems with the function of your thyroid. These antibodies can disrupt other hormone levels, thus affecting egg production. Treatment for high ATA levels may consist of steroids.
Antisperm Antibodies (ASA) can be found in both males and females. Males who have had vasectomy reversal or have injured their testicles can produce ASA (semen specimen) Female (blood test) ASA are found in the cervical mucus as well as in blood. The ASA attaches to the head of the sperm and make it hard for the sperm to penetrate an egg. IVF with ICSI treatment is recommended for couples with ASA.
The Anti Phospholipids Antibody (APA) test is conducted if you have had multiple miscarriages. APA can interfere with the embryo implanting. APA disrupts the normal clotting of blood and the adhesion of the embryo to the uterus. APA tests for a number of different antibodies. If your test results show that two or more are positive treatment is either by baby aspirin or heparin.
Antinuclear Antibodies (ANA) can increase your risk of miscarriage when the result is a low positive with a speckled pattern. If your result highly positive you may have a disease called systemic lupus erythematosus (SLE). A positive ANA level may be treated with low-dose steroids.
Antiovarian Antibodies (AOA). This test is ordered when early menopause or premature ovarian failure are possible diagnoses.
Natural killer (NK) cells of white blood cells that attack and destroy anything that is a foreign substance in the body. If the NK cell count is high these cells may be aggressive and attack a growing embryo. Treatment for NK cells is intravenous immunoglobulin therapy (IVIG). This can be very expensive procedure and controversial among infertility specialists. A drug called Enbrel can also be used to treat NK cells.

No, not necessarily. Although evidence shows that Zika virus infection during pregnancy is a cause of birth defects and other poor pregnancy outcomes, not all Zika virus infections result in these problems. At this time, we do not know how likely it is that a baby will have microcephaly or other problems if his/her mother is infected with Zika virus while she is pregnant.

A positive test result for Zika virus infection during pregnancy signals to your healthcare providers to watch your pregnancy more closely, meaning they might do more ultrasounds or other tests to check the growth and development of your fetus.

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.

Pregnant women who have recently traveled to an area with risk of Zika should talk to their doctor about their travel, even if they don't feel sick. Pregnant women should see a doctor if they have any Zika symptoms during their trip or after traveling. All pregnant women can protect themselves by avoiding travel to an area with risk of Zika, preventing mosquito bites, and following recommended precautions against getting Zika through sex.

By use of the complete panel, ~40% of all fertility clinic patients with male factor issues will be identified; patients who can be directed to the appropriate Assisted Reproductive Technology (ART) early on in their treatment avoiding ART that won’t work.
Your scores from the SDD and SDAD Tests, and the SCFA will provide information to your physician that will be used to individualize your patient care, directing you to the treatment options best for you!
Knowing more about both male and female factors that may be negatively affecting your fertility will help minimize the time, and emotional and financial cost for you to bring home a baby!
We are learning that some male factor issues are potentially reversible and/or treatable!

There are many factors that can contribute to male infertility. Some of these problems can be structural abnormalities, sperm production disorders, ejaculatory disturbances and immunologic disorders. Perhaps it is best to break them out into 2 categories: Productive Factors and Obstructive Factors. In some cases of male infertility, the production of sperm is impacted whereas in obstructive issues cause problems with transporting the sperm to the semen.

Here’s a breakdown of the many different types of male factor problems that can pose an issue to conceiving:

Structural abnormalities

It is possible that there can be an abnormalities of the reproductive tract, leading to potential obstructions that partially or totally block the flow of sperm and/or seminal fluid. Some of these abnormalities may be present at birth (congenital), others may have occurred after infection of the urogenital tract, whereas others may have resulted from previous surgery.

Congenital defects

Sperm production disorders

This occurs when the production of the sperm is inhibited.

Vasectomy
Varicocele
Sperm production problems

Ejaculatory disorders

These prevent sperm from reaching the female.

Retrograde Ejaculation
Impotence

Immunologic disorders

Immunological disorders can prevent sperm from meeting and successfully penetrating the egg in the female genital tract.

Endocrine disorders
Antisperm antibodies

From RESOLVE: The National Infertility Association

Currently, there is no evidence that a woman who has recovered from Zika virus infection (the virus has cleared her body) will have Zika-related pregnancy complications in the future. Based on information about similar infections, once a person has been infected with Zika virus and has cleared the virus from his or her body, he or she is likely to be protected from future Zika infections.

If you’re thinking about having a baby in the near future and you or your partner live in or traveled to an area with risk of Zika, talk with your doctor or other healthcare provider. See Women & Their Partners Trying to Become Pregnant.

Body Weight:

Obesity is associated with infertility and a lower pregnancy rate in women undergoing in vitro fertilization (IVF). Women with a very low body mass index (BMI) also are more likely to experience infertility and have a lower likelihood of success with IVF than women whose BMI falls in the normal range. In men, obesity is also associated with infertility — sperm count and motility have been shown to be lower in obese men. Weight loss has been shown to improve semen parameters. Erectile dysfunction is more common in obese men. There is no scientific data that supports one diet over another with respect to maximizing fertility.

Exercise:

Some data that suggest that moderate exercise, regardless of BMI, is associated with the highest pregnancy rates in women. Daily exercise, however, has been shown to be associated with reduced fertility—especially if the excessive exercise results in menstrual irregularity. Exercise has a similar effect on men—one hour of exercise three times weekly seems to be associated with a higher count, motility, and normal appearing sperm than sperm from men who do not exercise and those who engaged in more frequent/vigorous exercise

Caffeine Intake:

Excessive caffeine intake (>500 mg/day) appears to be associated with a delay in time to conception. Consumption of moderate amounts of caffeine (200-300 mg/day) has been associated with lower pregnancy rates and higher rates of miscarriage. In one study, pregnancy rates with IVF were reduced in women consuming greater than 50 mg of caffeine daily. There is little data on the impact of caffeine on male fertility. The average 8oz cup of coffee has approximately 100 mg of caffeine, but not all coffees are created equal—look up the caffeine content of your favorite caffeinated beverage.

Alcohol Consumption:

Extreme alcohol intake has been associated with decreased fertility. What is less clear is the amount of alcohol it takes to negatively impact reproductive function. A review of the literature suggested that four drinks per week is associated with a decreased likelihood of successful IVF in women. Heavy alcohol consumption in men is associated with decreased sperm count, motility, and percent of normal appearing sperm. Some studies have shown a negative impact on sperm with more moderate drinking. Semen parameters have been shown to improve after three months of abstinence from alcohol.

Smoking:

There is strong evidence that nicotine negatively effects fertility. It has been suggested that women who smoke add ten years to their reproductive ages—a 30 year old smoker has the reproductive potential of a 40 year old! Smoking in men negatively impacts sperm quantity and quality and is associated with reduced success with IVF and intra-cytoplasmic sperm injection (ICSI). There is little scientific data on the impact of electronic cigarettes on fertility, but they contain nicotine, so they are likely associated with a decrease in fertility. Ideally, nicotine patches and gum should be avoided.

Recreational Drugs:

Studies on the impact of recreational drugs on female fertility are few. Women who use marijuana appear to be more likely to experience infertility. In men, marijuana has been found to increase ejaculation problems and impotence as well as reduce sperm count and motility. Most negative effects from recreational drugs have been shown to be reversed by discontinuing their use.

Cell Phones:

In some animal studies evaluating the effect of the radio-frequency electromagnetic radiation (RF-EMR) of cell phones on reproductive function, a negative impact on the ovaries, uterus, and embryo has been identified. Sperm exposed to RF-EMF have decreased motility and are more likely to have an abnormal appearance. The use of cell phones may decrease sperm concentration and motility as well as normal appearance. The abnormalities seemed to be directly related to the amount of use. However, there is no evidence that use of cell phones by women or men is associated with infertility.

From RESOLVE: The National Infertility Association

Men who have traveled to a place with a CDC Zika travel notice or a red area of Zika active transmission in the United States should wait at least 6 months after travel (or 6 months after symptoms started if they get sick) before trying to conceive with their partner. Women should wait at least 8 weeks after travel (or 8 weeks after symptoms started if they get sick) before trying to get pregnant.

The waiting period is longer for men because Zika stays in semen longer than in other body fluids. Travelers to areas with risk of Zika but no CDC Zika travel notice should talk to their healthcare provider. Travelers to yellow Zika cautionary areas can consider waiting these timeframes before trying to conceive. If either partner has symptoms of Zika or tests positive for Zika after travel, they should follow the suggested timeframes above before trying to get pregnant.

Even if you have a negative test, you may have been infected with Zika virus. If your sample was collected just after you became ill, it is possible that your body had not yet had enough time to make antibodies for the test to measure. If the sample was collected more than 12 weeks after your illness, it is possible that your body has already fought off the virus and the amount of antibodies is so low that they cannot be measured. Your healthcare provider will help you to interpret your test results and work with you to continue to monitor your health and, if you are pregnant, the health of your fetus.

Inquiry into and removal from possible exposures to occupational and/or environmental reproductive toxicants, medications, alcohol, tobacco products and/or drugs of abuse (See Occupational Exposure Risks)
If you have an abnormal SDD Test score and a varicocele(s) identified by a urologist, recent unpublished data suggests you might benefit from a varicocelectomy.
Our most recent data shows that the daily use of Male Reproductive Supplements (MRS); anti-oxidant cocktails that include Vitamins C and E significantly improve abnormal SDAD Test scores.
It is very important you choose your ART wisely based on more than standard semen analysis where the typical treatment strategy is shown below!

The U.S. Food and Drug Administration (FDA) has not cleared or approved ZIKV Detect™ IgM Capture ELISA test or any other test to detect Zika virus infection. However, FDA has authorized the use of this test under an Emergency Use Authorization (EUA).

An EUA is a tool that FDA can use to allow the use of certain medical products for emergencies based on scientific data. The U.S. Secretary of Health and Human Services (HHS) has declared that circumstances exist to allow the emergency use of diagnostic tests for Zika virus infection, such as the ZIKV Detect™ IgM Capture ELISA, under an EUA.

FDA has authorized the emergency use of the ZIKV Detect™ IgM Capture ELISA to test for antibodies to Zika virus in your specimens only for the duration of the emergency, unless it is terminated or revoked by FDA sooner.

Yes. Currently, AMH is one of the most accurate and reliable markers of ovarian reserve. However, data does not support testing for many diagnoses. The following is a list of such conditions.

· AMH testing should not be used as a fertility test for women who are not infertile or who have untested fertility.

· Routine AMH testing for prediction of pregnancy loss is not recommended.

· AMH testing is not useful in predicting the likelihood of unassisted pregnancy in women with infertility.

· AMH testing does not appear to predict pregnancy after OS/IUI for unexplained infertility.

· Extremely low levels of AMH should not be used to refuse treatment in IVF.

· AMH may only have a weak association with egg quality, pregnancy rates, and live birth rates.

· AMH levels may be decreased in women using hormonal birth control. Results should be interpreted with caution.

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