End Fatigue

Study Population and Length

40 couples with infertility (including men with decreased sperm count and motility) who were unable to conceive after at least 1 year of unprotected intercourse will be recruited from my newsletter and physicians offices in Hawaii. The couples agree not to do In Vitro Fertilization or other infertility treatments (except those they are already on and have told Dr. Teitelbaum about) during the 9 months they will be in this study.

To Be in the Study

1.	Women need to be 18-35 years old and men 18-50 years of age.
2.	Women need to:

	A.	Have had a medical Obstetrical work up and found to be ovulating, and
	B.	Still be having periods,
	C.	Have no anatomic or other clearly defined causes for their infertility, and
	D.	Cannot be over 50 pounds overweight (which can cause ovulatory problems and increase pregnancy and miscarriage risk ).4
	E.	Cannot have been on thyroid hormone before the study (it is part of the treatment).

3.	Men needed to have a sperm count of at least 5 million (under 20 million is considered infertility, but the treatments may well raise the sperm count and function considerably if sperm are present. Treatments are less likely to help if no sperm are being made).
4.	Both the man and woman have to agree to undergo treatment and be part of the study.

Are There Any Costs Involved?

The over the counter natural supplements will be provided to you at no charge by Dr. Teitelbaum. As the study has no outside funding, you will be responsible for the costs of any lab tests (done at your local lab). These tests are those Dr. Teitelbaum believes should be done in general to evaluate and treat infertility. Insurance most often covers the cost, but Dr. Teitelbaum has no control over the insurance companies and cannot guarantee they will cover them. Except for the sperm tests which MUST be done within 2 weeks of entry into the study and at 4 months into treatment, or when the woman becomes pregnant (whichever occurs first), the other tests are OK if done in the last 18 months. The free T4 blood test will need to be done after 6 weeks on a stable thyroid dose. You (the participant) will cover the thyroid hormone costs (not expensive—Dr. Teitelbaum can assist if this poses a burden—cost is ~ 15-50 cents a day). You will do a pregnancy test any time you miss a period or feel you may be pregnant and notify Dr. Teitelbaum with the results. You also need to have been evaluated for your infertility by a physician, with no clear cause found.

These are the needed tests:

Women will need to supply lab results for Prolactin, Progesterone and FSH; iron, TIBC, Ferritin: Free T4, TSH, and Anti-TPO antibodies; DHEA-S, Free and Total Testosterone.

These tests are encouraged but OPTIONAL: Vitamin B12 and Folic Acid: ESR, BS, glycosylated hemoglobin & AM cortisol.

Men will need to supply a sperm count (volume of the semen, sperm number, motility and morphology assessment—after 2 -4 days of abstinence) and motility testing at baseline (in the month before beginning treatment) and 4 months after beginning treatment. If available, lab results for FSH, LH, Prolactin, Free and Total Testosterone; Free T4 and TSH will be reviewed.

What are the Treatments?

Treatment/Interventions in the Women

Life Style Education

These are important things to avoid from now until after you are 3 months pregnant, as they can cause infertility. Just do the best you can with these guidelines—OK to not be "perfect" with them.

1.	Avoid coffee and sodas5 (tea is OK). Coffee and sodas inhibit fertility—often markedly. Especially avoid caffeine if your Prolactin blood test is LOW as it can lower it further.
2.	Avoid melatonin (which is sometimes used to treat insomnia) as it can affect reproductive hormones.6
3.	Avoid taking over 900 mg of supplemental vitamin C (causes reversible infertility). Taking 750 mg a day of vitamin C, however, helps infertility7 so we will supply this amount. Do not take over 7000 units of supplemental vitamin A (causes birth defects—beta carotene is OK) daily. The supplement we supply has 3500 IU of vitamin A (the other 3,500 IU it contains is beta carotene).
4.	Avoid hot tubbing (it increases birth defect risks). A hot bath, which is not over 100 degrees in temperature, is a safer way to relax. In a bath much of your upper body will remain out of the water, making you less likely to overheat. Additionally, the water in a bath begins to cool off, as opposed to a hot tub, further reducing any risk of overheating.8 A hot tub is usually set at 102-104 degrees, which can overheat your body and can harm the baby.
5.	Avoid a high protein/Atkins' diet9 (an Atkins-like diet in a rat study decreased fertility over 50%).
6.	No alcohol if Prolactin levels are higher than 10 (and avoid in general as is convenient).10
7.	Avoid vaginal lubricants such as FemGlide, Replens and Astroglide which can damage sperm. Pre-seed brand is OK.11
8.	If you smoke, stop until after the baby is born. Smoking contributes to infertility in many ways.12

Lifestyle Things to Do to Help Get Pregnant

1.	It works best to have intercourse on the day you ovulate and up to 4 days before (otherwise "ad lib" whenever you feel like it). It is OK to have intercourse multiple times during this period. For purposes of getting pregnant, intercourse even 1 day after ovulation is unlikely to result in pregnancy—but OK to do anyway for its other benefits.
2.	Enjoy milk products, but use regular ones that have the normal amount of milk fat (e.g., whole milk) instead of low-fat or fat-free milk products. In a Harvard study, high intake of low-fat dairy foods was associated with an increased risk of infertility, while an increased intake of high-fat dairy foods was associated with a lower risk of infertility. Women consuming at least 2 servings of low-fat dairy foods per day showed an 85% increased risk of infertility. On the other hand, women consuming at least 1 serving of high-fat dairy foods per day showed a 27% reduced risk of infertility.13 Whole milk products (instead of low-fat ) also taste better ;-)

Treatments

1.	Supply overall nutritional support with the "Energy Revitalization Powder" by Enzymatic Therapy and a healthy, well-balanced diet.14-17 As noted above, dieting and high protein/low carbohydrate diets are to be avoided.18-19 Stay on these when you get pregnant and through breast feeding.
2.	Add prescription Armour thyroid 30 mg adjusted to dose that feels best (to a maximum of 90 mg) while keeping Free T4 < 75% of the upper limit of normal. Take it in the morning. DO NOT TAKE IRON OR CALCIUM SUPPLEMENTS WITHIN 6 HOURS OF THE THYROID DOSE, OR THE THYROID WILL NOT BE ABSORBED. Take your calcium at dinner and bedtime. If you get shaky or hyper or racing heart, lower the thyroid dose (or stop it) and let's discuss. Stay on the thyroid through your pregnancy (it supports a healthy pregnancy).
3.	Optimize iron levels. If the ferritin blood test is under 80 or iron percent saturation under 25%, treat with an iron tablet 1 a day after 2 PM on an empty stomach.20-21 Continue the iron through your pregnancy.
4.	If PCOS (Poly Cystic Ovary Syndrome) is present (often present when testosterone or DHEA-S levels are elevated), research shows that treatment with the medication metformin 1,500-2,000 mg/day not only increased fertility, but also decreased the risk of serious birth defects considerably.22-26
5.	If the Prolactin level is over 10, alcohol and melatonin (which can raise Prolactin) are to be strictly avoided. Vitamin B6 100 mg or as needed to bring Prolactin within the normal range (but not greater than 200 mg of B6) will be added. Stop the extra B6 (except for what is in the B complex) around 7 months into the pregnancy (otherwise it can suppress breast milk).
6.	If folic acid levels are low (lowest 20% of normal range) a blood test looking for wheat allergies will be recommended and a gluten free diet instituted if positive. Also, Folic Acid 5 mg twice a day will then be added.27

Treatment/Interventions in the Men

Life Style Education

These are important things to avoid from now until after your wife gets pregnant, as they can cause infertility. Just do the best you can with these guidelines—OK to not be "perfect" with them.

1.	When convenient, avoid meat with Estrogen (i.e., get your meat from a natural foods store).
2.	Avoid soy based foods (e.g., tofu, tempeh, soy cheese and milk, etc). Even modest intakes drop sperm counts by 40%.28
3.	Avoid Melatonin, Testosterone, Verapamil and Nifedipine (latter 2 are heart/blood pressure medications) which can cause reversible infertility.
4.	Avoid alcohol when convenient29 and tobacco.30
5.	Sperm do poorly at temperatures over 96 degrees (which is why the testes hang below the rest of the body to stay cooler). Avoid elevated scrotal temperatures by wearing boxer shorts. Do NOT wear briefs, tight fitting underwear or jeans. Avoid hot tubs. Avoid rowing/ski machines, treadmills or jogging unless the testes can hang free.
6.	Avoid aspirin, Motrin or similar medications which block the hormone prostaglandin (Prostaglandins in the seminal fluid may assist sperm ). Tylenol is OK in moderation (if you need high doses regularly, let's discuss).
7.	Increase liquid vegetable oils and avoid cottonseed (may contain gossypol which inhibit sperm function)31, palm or coconut oils or trans, hydrogenated or saturated fats as comfortably able.

Treatments

All of these can be taken together in the morning (or split up or taken any time of day):

1.	Supply overall nutritional support with the "Energy Revitalization Powder" (contains > 50 nutrients including 750 mg of vitamin C and 100 IU of vitamin E32-35 by Enzymatic Therapy. It also supplies folic acid36-37 and antioxidants.38
2.	Coenzyme Q10 (chewables—contains 400 IU of vitamin E as well) 200 mg/day.38
3.	L-Arginine 4 gm/day.39
4.	Acetyl-L-Carnitine 1,000 mg/day and Carnitine 1,000 mg/day markedly improves sperm motility and the sperms defenses against attack.40-42
5.	Zinc 15 mg/day.43
6.	Ribose (Corvalen) 5 gm twice a day (can use like sugar and mix in food or drinks or use the chewable tablets). In many studies this increases energy production, which may also help sperm motility. The second dose can be taken any time during the day.

The Benefits of Being in the Study Are:

1.	Get all the supplements for the man and woman free.
2.	Get the thyroid hormone prescription (most non-holistic doctors will not give it if the labs are normal no many how badly you need it).
3.	Dr. Teitelbaum will evaluate the labs pertinent to the study to help tailor your treatment and will be able to answer questions for you about treatment.
4.	Not just can you get your baby, but the study can help everyone else with infertility.

This is NOT a placebo controlled study. Everyone will be getting the active treatment.