End Fatigue

Infertility Study—Information for Those Entering the Study

Study being done by the From Fatigued to Fantastic! LLC.

How to Get a Print Version of This Page

The following is a letter to anyone who would like to participate in Dr. T's upcoming infertility study. Those who do will need to fill out a questionnaire (there is one for men and one for women) and sign a consent form, and then FAX or mail those to Dr. T's office. This page shows both the questionnaire and consent forms. If you would like to participate in the study, please DO NOT print this web page directly to get the questionnaire and consent forms. Instead, use the print version described in the next paragraph.

Click here to download a printable version of this letter. It is the same as this page, but includes instructions for where to mail the completed forms, and is "print-friendly."

Dear Friends,

You are not alone in your struggles with infertility.

Infertility affects many young couples (estimates are as high as approximately 1 in 6), and the prevalence is increasing. Data from the Centers for Disease Control and Prevention (CDC) National Survey of Family Growth done back in 1995 showed 6.1 million infertile women ages 15 to 44, 9.1 million using infertility services, and 2.1 million infertile married couples in the United States.¹ According to a press release from the National Fertility Association, the data from 2002 indicates an increase in the number of infertile people in the United States to 7.3 million.²

These numbers are continuing to rise as sperm counts drop worldwide and undiagnosed thyroid problems increase—so you are not alone. "It looks as if the amount of infertility in the Western world could double in the next decade," Prof. Bill Ledger, a fertility expert at Sheffield University in England, told a June 2005 meeting of the European Society of Human Reproduction and Embryology.

Various factors may be responsible for women's inability to achieve a successful pregnancy. Despite research showing that fertility declines after age 30, women are delaying having children. Infertility may be caused by ovulatory, anatomic, immunologic, infectious, nutritional or hormonal factors on the woman's side. In men, abnormalities of semen parameters are the most common contributors. In 1940, the average sperm count was 113 million/ml. By 1990 this had dropped to 66 million sperm/ml and semen volume dropped approximately 20% from 3.4 to 2.75 cc. These represent an approximately 60% decrease in sperm per ejaculate over a 50 year period.³ Treatments that improve cellular energy production may dramatically increase sperm motility (see below).

After a thorough work-up, treatment can sometimes be planned that aims to correct the problems identified. In many cases, however, the cause of the infertility remains unexplained. In this setting, the only option many couples are given is IVF (In Vitro Fertilization). IVF is given attention because it costs approximately $30,000+, while research on inexpensive natural options has been ignored (not because doctors don't care, but simply because no one will pay to publicize the information).

The good news is that there are many highly effective natural ways to improve many steps of the reproductive process. A large number of studies have successfully explored the use of individual nutritional and hormonal therapies to do this—resulting in women with unexplained/untreatable infertility often getting pregnant!

We are testing the hypothesis that by simultaneously combining many of these proven natural therapies to optimize both the reproductive milieu in woman, and sperm counts and function in men, many if not most couples with unexplained infertility and/or infertility associated with low sperm counts will be able to get pregnant.

Study Population

40 couples with infertility (including men with decreased sperm count and motility) who have been unable to conceive after at least 1 year of unprotected intercourse. 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 of this study.

Study Design

This is an open, non-blinded, pilot study. Everyone gets the real treatment (i.e., no placebos).

To Be In the Study (Inclusion Criteria)

	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 60 pounds overweight (which can cause ovulatory problems and increase pregnancy and miscarriage risk ).4
		e.	cannot have been on Armour Thyroid hormone before the study (it is part of the study treatment) or have angina or abnormal heart rhythms that would prevent taking thyroid hormone.

	3.	Men need 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/motility 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 for 9 months or until the woman gets pregnant.

Evaluation

A questionnaire will elicit the pertinent medical history (see below).

Lab Evaluation

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. After 6 weeks on your optimal dose of natural thyroid hormone, repeating a simple thyroid blood test is also recommended.

Optional but helpful: Vitamin B12 and Folic Acid: ESR, BS, glycosylated hemoglobin & AM cortisol.

For the women, testing done in the previous 18 months can be used, and most of these tests may have already been done for your infertility evaluation.

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 (within a month of 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, but these are optional.

Please feel free to fax us all your lab reports from the last 18 months (fax to 808-329-5534), and I'll let you know if any other labs are needed and send you a prescription to take to your lab.

You are responsible for the cost of testing (can be done at any lab, and insurance usually covers these) but we are happy to supply a lab request/order to have the labs done.

What the Study is Testing for:

	1.	In women, getting pregnant within 9 months.
	2.	In men, changes in sperm count, motility and morphology and
	3.	Overall well being in both men and women.

What are the Treatments We’ll Recommend?

Treatments will consist of both life-style changes as well as nutritional and/or thyroid hormone/medication support (when needed). Both are important, and we strongly encourage you keep to the recommendations below. Having said this, this is a guilt free protocol and occasional lapses are not likely to be that harmful. We encourage you to do the best you can, but be easy on yourself (don't need to be "perfect"). If there is a treatment you can't do, let us know.

Here are the treatments. The footnotes refer to the scientific studies showing the effectiveness of each recommendation we are making.

Treatments to be done by the woman (only)

A. 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 supplements with 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 daily (causes reversible infertility). Taking 750 mg a day of vitamin C, however, helps infertility,7 so we will supply this amount. Do not take over 7,000 units of supplemental vitamin A (causes birth defects—beta carotene is OK) daily. The supplement we will supply has 3,500 i.u. of vitamin A (the other 3,500 i.u. it contains is beta carotene).
	4.	Avoid hot tubbing after you get pregnant (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

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.

B. Treatments (we will provide). Most women will simply need to take the vitamin powder, thyroid, and if low an iron supplement.

	1.	Get outstanding 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. We will supply the powder. Take ½ to 1 scoop a day as feels best (use less if diarrhea) and the one capsule. When you get pregnant, add calcium, iron, and fish oil to optimize your pregnancy.
	2.	2. Add prescription Armour thyroid 30 mg adjusted to dose that feels best (to a maximum of 90 mg or 3 tablets) while keeping the Free T4 blood test in the normal range. Take it in the morning, preferably on an empty stomach. DO NOT TAKE IRON OR CALCIUM SUPPLEMENTS WITHIN 6 HOURS OF THE THYROID DOSE, OR ELSE THE THYROID WILL NOT BE ABSORBED. Take your calcium at dinner and bedtime. If you get shaky or hyper, chest pain 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). Low thyroid function despite normal tests is an extremely common cause of both infertility and miscarriages.
	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 at a dose of 100 mg/day 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

Treatments to be done by the man (only)

A. 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 oil (may contain gossypol which inhibit sperm function),31 palm or coconut oils, or trans, hydrogenated or saturated fats as comfortably able.

B. Treatments (we will mail these to you after obtaining the first sperm count report).

All of these can be taken together in the morning (or split up or taken any time of day). They increase sperm count and function, and your energy as well! Get your baseline sperm count sample in to the lab/urologists office before beginning these treatments. Repeat the sperm count after 4 months on these treatments (best if the baseline and 4 month sperm counts done are done at the same lab if not too difficult). Take these supplements for 9 months or till your wife gets pregnant. If pregnant before 4 months into treatment, repeat the sperm count and then you can stop the supplements.

	1.	Supply overall nutritional support with the "Energy Revitalization Powder" (contains over 50 nutrients, including 750 mg of vitamin C and 100 i.u. of vitamin E32-35) by Enzymatic Therapy. It also supplies folic acid36-37 and antioxidants.38 We will supply the powder. Take ½ to 1 scoop a day as feels best (use less if diarrhea) and the one capsule.
	2.	Coenzyme Q10 (chewables—contains 400 i.u. of vitamin E as well) 200 mg/day.38
	3.	L-Arginine 4 gm/day39
	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 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 (or at bedtime).

Patient Questionnaire (Woman’s)

Natural Treatment of Infertility Study Questionnaire—FEMALE

(Note: The following are the questions study participants will find on the questionnaire forms when they download the printable version of this letter. The print version will have spaces provided for you to write your answers.)

Name | Date
Address (to send supplements to)
E-mail | Phone
Height | Weight | Age | Date of Birth

	1.	Please describe what your experience with infertility, including evaluation and treatments, has been (can use back of this page as well) and how it has affected your life.
	2.	How long have you been trying (without success) to get pregnant? Have you ever been pregnant? If yes, describe details in the space below (e.g., outcome, miscarriages, pregnancy terminations, problems during pregnancy, delivery or postpartum period).
	3.	Have you been evaluated for infertility? By whom? What did they say was causing it?
	4.	Are your periods regular? When did you start your most recent period?
	5.	Check any of these that you have or have had: ____ Endometriosis ____ Pelvic Surgery (describe and when) ____ Pelvic Infections ____ Ovarian cysts /PCOS (Polycystic Ovary Syndrome) ____ Excess body hair ____ Uterine fibroids ____ High Prolactin levels ____ Any breast milk when not breast feeding
	6.	Adrenal Checklist. Please put a check mark next to the symptoms you have: ____ Hypoglycemia ____ Shakiness relieved with eating ____ Low blood pressure ____ Dizziness on first standing ____ Have you ever been on Prednisone (Cortisone)? If yes, did you feel better when you took it?
	7.	Thyroid Checklist. Please put a check mark next to the symptoms you have: ____ Weight gain? (______ lbs over _____ years) ____ Low body temperature (under 98 degrees) ____ Achiness ____ Ever been diagnosed with a low thyroid? ____ Cold intolerance ____ Heavy periods—Females only
	8.	Do you use anything to predict ovulation? Describe.
	9.	Please list all treatments you’re on (Prescription and Natural).
	10.	Any allergies? If yes, please list.
	11.	Any history of medical problems? If yes, please list.
	12.	Any history of heart problems or abnormal rhythms or chest pain?
	13.	Any surgeries? If yes, please list.
	14.	Have you tried In Vitro Fertilization (IVF)? If yes, when? Are you currently doing IVF? Did the IVF work? Please give more details about your IVF experience on a separate page.
	15.	Any family history of infertility or other medical problems? If yes, please list.
	16.	Do you smoke?
	17.	How many ounces of coffee do you drink a day? Decaf or regular?
	18.	How many ounces of soda do you drink a day? Diet or regular?
	19.	How much alcohol do you drink a day?
	20.	How much TOTAL vitamin C a day do you get from all your supplements?
	21.	How much TOTAL vitamin A (NOT beta carotene) a day do you get from all your supplements?
	22.	Do you or your husband take Melatonin? Who and what dose?
	23.	Do you use vaginal lubricants (such as FemGlide, Replens and Astroglide)? If so, which one(s)?
	24.	Have you been on any diets since this began? What kind (e.g., Atkins, South Beach, low carb)?
	25.	Any thing else we should know about you or your husband/partner (can also use a separate page)?

Patient Questionnaire (Man’s)

Natural Treatment of Infertility Study Questionnaire—MALE

(Note: The following are the questions study participants will find on the questionnaire forms when they download the printable version of this letter. The print version will have spaces provided for you to write your answers.)

Name | Date
Address (to send supplements to)
E-mail | Phone
Height | Weight | Age | Date of Birth

	1.	Please describe what your experience with infertility, including evaluation and treatments, has been (can use back of this page as well) and how it has affected your life.
	2.	Have you fathered any children in the past? When? Was it with your current partner?
	3.	Have you been evaluated for infertility? By whom? What did they say was causing it? Did you have a sperm count? What did it show? Did you have Mumps as an adult? Any difficulty with erections? Any testicular lumps or problems? Burning on urination or urinary frequency? Ever had a vasectomy? If yes, was it reversed?
	4.	Are you on or have you taken Verapamil, Nifedipine, Melatonin, Testosterone? If so, when was the last time and when did you start it? Are you still taking it? If yes, which one(s)?
	5.	What kind of underwear do you wear? (e.g., boxer shorts, briefs, tight vs. loose/hanging)?
	6.	Do you exercise using rowing/ski machines, treadmills or jogging? If yes, which one(s)?
	7.	Do you use any arthritis or pain medications (e.g., Motrin, Aleve, aspirin, Codeine)? If yes, which one(s)?
	8.	Do you cook with cottonseed oil?
	9.	Please list all treatments you’re on (Prescription and Natural).
	10.	Any allergies? If yes, please list.
	11.	Any history of medical problems? If yes, please list.
	12.	Any surgeries? If yes, please list.
	13.	Any family history of infertility or other medical problems? If yes, please list
	14.	Do you smoke? Chew tobacco?
	15.	Do you or your wife take Melatonin? Who and what dose?
	16.	Do you use vaginal lubricants (such as FemGlide, Replens and Astroglide)? If so, which one(s)?
	17.	Any thing else we should know about you or your wife/partner (can also use a separate page)?

References/Footnotes:

(See the printable version of this letter for the full list of references and footnotes.)

CONSENT FORM

Thank you for participating in our study. Although we expect it to be very safe, all studies, especially any involving pregnancy, require that risks and issues be disclosed so that we have obtained informed consent from you so that you may be in the study.

This consent form may contain words that you do not understand. Please ask the study doctor or the study staff to explain any words or information that you do not clearly understand. You may take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision.

In this consent form, “I,” “me,” “my,” “you” and “your” always refers to the subject signing this form who is the study participant.

It is important that people with infertility undergo a thorough medical evaluation to look for its underlying causes. It is not the purpose of this study to do this, and in signing this I am affirming that I have already had such a medical evaluation. The purpose of this study is to offer an integrated treatment protocol using a number of treatments that have been found to be helpful-but which are often ignored in standard medicine (either because the treatments are inexpensive and therefore not publicized, or are based on smaller studies, as is often the case with natural remedies, as there is little financial support for larger studies).

Holistic physicians have found that natural remedies are often both very safe and effective. Because of this, and the need for people to be able to get the help they need, Dr. Teitelbaum's FFTF LLC sometimes personally funds or runs studies which have been very helpful for people that standard medicine has been unable to help. He does this for no pay or reimbursement. In light of this, to be in the study, Dr. Teitelbaum needs to ask that you agree to the following:

	1.	I agree that I will not hold Dr. Teitelbaum, his staff, foundation, the FFTF, LLC or anyone else to be legally responsible for any damages or injuries to myself or my baby, perceived or real, arising from this study. I will not bring any legal or other actions or allow anyone else to do so on my or the baby's behalf.
	2.	I realize that in the general population, the risk of congenital anomalies is about 2-3% and about 4% in the infertile population. I recognize that some standard physicians have a strong bias and will sometimes have a tendency to blame any problems that happen on natural therapies-no matter how baseless their bias. I recognize that there is a risk of birth defects and I again agree that I will not hold Dr. Teitelbaum, his staff, or anyone else to be legally responsible for any damages or injuries to myself or my baby, perceived or real, arising from this study. I will not bring any legal or other actions or allow anyone else to do so on my behalf.
	3.	For the woman—Thyroid supplementation: I realize that although thyroid hormone is quite safe overall and many believe that, like exercise, it’s healthy for the heart, in those on the edge of a heart problem the thyroid can (again like exercise) unmask it. I will notify Dr. Teitelbaum of any heart problems I have before beginning the thyroid hormone. I agree that I will ask my personal physician to concur that I have no known underlying heart problems that would make it risky to take a low dose of thyroid. I understand that most standard physicians are against taking thyroid if the thyroid tests are normal (despite research supporting it) and may even be hostile about this (usually if they are hostile to natural remedies in general). I understand and accept the information below on thyroid use:

Thyroid supplementation: Research suggests that thyroid therapies can be very helpful in infertility and pregnancy—even if your blood tests are normal. This treatment is, however, very controversial—even though it's usually very safe. However, all treatments (even aspirin) can cause problems in some people. The main risks of thyroid treatment are:

	1.	Triggering caffeine-like anxiety or palpitations. If this happens, I will cut back the dose and increase by ½ to 1 tablet each 3-4 weeks (as is comfortable) or slower and let Dr. Teitelbaum know the results. If I have severe, persistent racing heart, or if I have chest pain, I will call my family doctor and/or go to the emergency room.
	2.	Like exercise (e.g., climbing steps), if one is on the edge of having a heart attack or severe ‘racing heart’ (atrial fibrillation), thyroid hormone can trigger it. In the long run though, many Holistic Physicians suspect, and many studies suggest, that thyroid may decrease the risk of heart disease. Nonetheless, I agree that if I experience chest pain, I will go to the emergency room and/or call my family doctor. It will likely be chest muscle pain (not dangerous) but better safe than sorry. To put it in perspective, Dr. Teitelbaum has never seen thyroid hormone trigger heart disease in one of his patients despite treating thousands of patients with thyroid. Increasing thyroid dose to levels above the upper limit of the normal range may accelerate Osteoporosis, which is one reason Dr. Teitelbaum’s specifies a low dose. Because of this, I agree to check my thyroid (Free T4—not TSH) levels after 4 to 8 weeks on my optimum dose of thyroid hormone. In addition, if I have risk factors or Angina or heart problems, I will do an exercise stress test or get my physician’s OK to take thyroid to make sure my heart is healthy before beginning thyroid treatment. These risk factors include: 1. Diabetes, 2. Elevated cholesterol, 3. Hypertension, 4. History of Angina, 5. History of abnormal heart rhythms. I will not take over 90 mg a day of the Armour thyroid. All this having been said, Dr. Teitelbaum has found treatment with thyroid hormone to be safer than Aspirin and Motrin. I will not take thyroid within 6 hours of iron or calcium supplements (as it prevents absorption of the thyroid hormone).

General Issues

The most common side effects would be nausea or gas/loose stools from the Energy Revitalization System vitamin powder (simply lower the dose to resolve), constipation/black stools from the iron, or feeling hyper/over energized from the thyroid or ribose/Corvalen (lower the dose or stop it to resolve).

I am aware that anything I am being given may have an unknown risk or possible risks during pregnancy or on sperm development. The study is only recommending things for the woman that the FFTF LLC considers to be safe and reasonable to use in pregnancy and for men that are considered to be safe while trying to father a child.

I understand that this is an informal “pilot” study to explore whether larger studies are warranted, and that it is therefore not being done under the guidance of an institutional review board. I agree that no doctor/patient relationship is being established in this study.

I affirm that my spouse/partner agrees to this study as well.

The information from this research study may lead to natural therapies being offered as an option for people with infertility.

Costs

The over the counter natural supplements will be provided to study participants at no charge. As the study has no outside funding, I (the study couple) will be responsible for the costs of any lab tests. 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 women 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. I (the participant) will cover the thyroid hormone costs (not expensive—Dr. Teitelbaum can assist if this poses a burden—cost is approximately 30-50 cents a day). I will do a pregnancy test anytime I miss a period or feel I may be pregnant and notify Dr. Teitelbaum with the results.

Payment for Participation

You will not receive any financial payment for your participation. The study will offer the supplements and guidance on using them at no charge.

Alternatives

You have the option to not participate in this study and do IVF or other standard treatments instead.

I agree not to do In Vitro fertilization or other infertility treatments (except those I am already on and have told Dr. Teitelbaum about) during the 9 months of this study.

Authorization to Use and Disclose Information for Research Purposes

Federal regulations give you certain rights related to your health information. These include the right to know who will be able to get the information and why they may be able to get it. The study doctor must get your authorization (permission) to use or give out any health information that might identify you.

What information may be used and given to others?

If you choose to be in this study, the study doctor and sponsor will collect personal information about you (the questionnaire you fill out and any medical records you supply us). You will have a number/letter code assigned to your name.

Who may use and give out information about you?

Information about your health may be used and given to others on Dr. Teitelbaum’s staff that are assisting in the study. They might see the research information during and after the study. Otherwise, any information used will not have your identifying information. (e.g., the study might note “25% of women had a lab value under…”). Dr. Teitelbaum takes protecting your privacy very seriously.

Voluntary Participation and Withdrawal

Your participation in this study is voluntary. You may decide not to participate in this study. If you do participate, you may freely withdraw from the study at any time.

I recognize and agree that my or Dr. Teitelbaum’s participation in this study may be stopped at any time by Dr. Teitelbaum as well.

I will notify Dr Teitelbaum if I stop the study treatments, have any problems, and/or when I get pregnant. He would love a picture of you with the baby ;-)

We (the following named) agree to the preceding consent form.

Name of Man (Print) _______________________________
Signature ________________________ Date ___________

Name of Woman (Print) ____________________________
Signature ________________________ Date ___________