![7. REFERENCES
1. Yoshimoto, Y.; Wolfsen, A. R.; & Odell, W. D. (1979). Glycosylation, A Variable in the
Prodection of hCG by Cancers. American Journal of Medicine, 414-420.
2. Shalit, A; Jaschevatzky, OE; Kampf, D; Leiserowitz, DM; & Gr¨¹nstein S. (1980). Human
chorionic gonadotropin in intrauterine device users. International Journal Of Fertility, 134-136.
3. Simeons, A. (1954). The action of chorionic gonadotropin in the obese. Lancet, 946, 947.
4. Novarel?
(Chorionic Gonadotropin for Injection, USP) [package insert 2011]. Quebec,
Canada; DRAXIS Specialty Pharmaceuticals Inc.
5. Cole, L. A. (2009). New discoveries on the biology and detection of human chorionic
gonadotropin. Reproductive Biology and Endocrinology, 8-45.
6. Sure-Vue?
Serum/Urine hCG [package insert, 2008]. Houston, TX; Fischer Scientific
Healthcare.
7. Noci, I.; Saltarelli, O.; Coccia, E.; Messo, A.; Livi, C.; Massi, G. B.; & Messeri, G. (1987).
Interference of exogenous HCG on pregnancy tests. Acta Eur Fertil, 391-393.
8. Butler, S. A.; Khanlian, S. A.; & Cole, L. A. (2001). Detection of Early Pregnancy Forms of
Human Chorionic Gonadotropin by Home Pregnancy Test Devices. Clinical Chemistry, 2131-
2136.](https://image.slidesharecdn.com/08fe152e-f499-4458-b882-729e25bace7e-160729172211/85/Woolsey-Goff-The-Effects-of-hCG-Diet-Injections-on-Common-Pregnancy-Tests-6-320.jpg)
More Related Content
Viewers also liked (9)
Similar to Woolsey & Goff - The Effects of hCG Diet Injections on Common Pregnancy Tests (20)
Woolsey & Goff - The Effects of hCG Diet Injections on Common Pregnancy Tests
- 1. The Effects of hCG Diet Injections on Common Pregnancy Tests Cory Woolsey and Jaren Goff Medical Laboratory Sciences Weber State University 3905 University Circle Ogden UT 84403-3905 USA Faculty Advisor: Gary Nielsen ABSTRACT The purpose of this study was to determine if hCG diet injections cause non-pregnant women to obtain unreliable pregnancy test results. Common clinical and home pregnancy tests detect levels of the hCG hormone in the blood or urine. The hCG pregnancy hormone is the same hormone used in the hCG diet. This study consisted of 15 non-pregnant and non-menopausal women who were selected from an hCG diet clinic in Springville, Utah. Participants were selected based upon answers given in a preliminary questionnaire. All participants were tested before or after their course of exogenous-hCG injections to establish a control. Experimental data were obtained by performing pregnancy tests on the participants¡¯ blood and urine while they were taking their course of exogenous-hCG injections. Experimental data showed that of the 15 women that participated in this study all tested positive on the serum hCG test and 14 of the women tested positive on the urine hCG test. These results indicated that exogenous-hCG injections can cause non-pregnant women to obtain unreliable pregnancy test results. This information would be useful for physicians and those who participate in injectable hCG diets. Keywords: hCG, Diet, Pregnancy Test 1. INTRODUCTION The purpose of this study was to determine if hCG diet injections cause non-pregnant women to obtain unreliable pregnancy test results. The information that supports this study is divided into four subsections within the introduction of this paper, in the following order: Biological-hCG, The hCG Diet, The Pregnancy Test, and The hCG Connection. 1.1. Biological-hCG Human chorionic gonadotropin (hCG) is a hormone that is naturally produced by the pituitary gland of all humans. It is also produced by developing embryo blastocysts, and the placenta in pregnant women. The hCG from these sources can be found and tested for in blood and in urine. Excluding the timeframe of menopause, the pituitary gland secretes very small amounts of hCG that should never be detected during a pregnancy test. During menopause the pituitary gland can secrete enough hCG to cause a pregnancy test to turn positive. Developing embryo blastocysts produce far more hCG than the pituitary gland. Embryonic-hCG is produced to cause the corpus luteum to continue secreting progesterone in the ovary. Continued progesterone secretion is vital to prevent regular menstruation which allows the embryo to grow in the womb. Tumors and
- 2. cancers such as hydatidiform moles, choriocarcinoma, and testicular germ cell tumors may also secrete large amounts of hCG1 . Numerous studies show that contraceptives are also known to cause an increase in hCG production, but generally do not elevate the hCG level high enough to be of concern for the purpose of this study. The source of hCG during contraceptive use is believed to be from the pituitary gland2 . An example of this would be the study made on the effect of an intrauterine contraceptive on hCG levels. The serum hCG levels obtained in the study were all less than three milli-International Units per milliliter (3 mIU/mL). Three molecular forms of hCG exist. 1) Regular hCG; 2) glycosylated-hCG, hCG covered with greater concentrations of carbohydrates than does regular hCG; 3) free-hCG, hCG that is free of carbohydrates. Embryo blastocysts; hCG producing tumors and cancers; and pituitary glands all vary in how they attach carbohydrates to hCG. The altered attachments of carbohydrates can be used to tell the difference (differentiate) between the origins of the hCG molecules1 . However, common clinical and home pregnancy tests cannot differentiate between the regular hCG, glycosylated-hCG, and free-hCG. Therefore, for the purpose of this study, all three isoforms created by the body will be referred to as ¡°biological-hCG.¡± 1.2. The hCG Diet The hCG diet was originally created by Dr. Simeons in the 1950¡¯s. His method of the diet consists of a restriction of calorie intake to 500 kilocalories (Calorie or Cal) per day, while injecting hCG into the thigh or stomach fat with a small needle. The injectable form of hCG used in the hCG-diet will be referred to as ¡°exogenous-hCG¡± throughout this paper; exogenous meaning ¡°from without.¡± An oral administration of exogenous-hCG exists for the hCG diet, but for the purpose of this study only the use of injectable hCG will be examined. When an adult performs a 500 Cal diet without the additional intake of exogenous-hCG, hunger and breakdown of muscle tissue are naturally experienced before fat tissue is broken down for energy. According to Dr. Simeons¡¯ theory, the addition of exogenous-hCG to a 500 Cal diet allows an adult to experience an increased release of stored triglycerides from fat tissue into the blood. Increased weight loss results from the triglycerides being released from fat tissues and being utilized for energy in the body3 . Exogenous-hCG is made by collecting the urine of pregnant women, then isolating and purifying biological-hCG to a level safe enough to be injected into a human4 . This means that exogenous-hCG is the same hCG hormone found in the urine of pregnant women. Biological and exogenous-hCG are identical in structure and source. 1.3. The Pregnancy Test The hCG hormone is composed of two protein subunits known as alpha (¦Á) and beta (¦Â). The ¦Â- hCG-subunit is unique in design and is sought after as a binding site for testing purposes to create a more sensitive pregnancy test5 . The most common forms of clinical and home pregnancy tests are based upon an immunological reaction between the anti-¦Â-hCG antibody, its antigen ¦Â- hCG, and colloidal gold-labeled hCG reagent molecules.
- 3. When biological-¦Â-hCG is present in concentrations above the measurable threshold, a positive indicator becomes visible on the pregnancy test. No color change occurs on the test if there is an insufficient concentration of hormone present; hence the test is interpreted as being negative6 . After searching through research articles the minimum detection level values for pregnancy tests were found to range between 5 mIU/mL and 50 mIU/mL. Common clinical and home pregnancy tests are qualitative tests. They only report whether or not there is a minimum amount of hCG hormone present in the woman to turn the test positive. When the test turns positive this may indicate that the woman is pregnant. This must be confirmed with a physician and a follow up pregnancy test. The tests do not differentiate between biological-hCG and exogenous-hCG. If a test says that a woman is pregnant, and she is not pregnant, then the test is considered to be ¡°false-positive.¡± 1.4. The hCG Connection If the ¦Â-hCG pregnancy test assays for the ¦Â-subunit of biological-hCG, then it is expected that the ¦Â-subunit of exogenous-hCG will also react with the anti-¦Â-hCG antibodies of the pregnancy test. This means that if a woman takes exogenous-hCG injections, and her body¡¯s concentration of exogenous-hCG is high enough, a common ¦Â-hCG pregnancy test of her urine or serum should result false-positive. This is exactly what happened with Noci et al.7 , where pregnancy testing was performed on women injected with exogenous-hCG for ovulation inducement. Noci et al. injected 5,000,000 mIU of exogenous-hCG on days 3, 5, and 7 after ovulation and obtained false-positive pregnancy test results up to day 12 using pregnancy tests of 50 mIU/mL sensitivity. Currently, there is no data available that proves that an exogenous-hCG injection regimen used for the hCG diet could cause a false-positive pregnancy test. If false-positive pregnancy tests show up during testing for this study, then the information would be useful for physicians and those who participate in the hCG diet. As seen from the results and conclusion of this paper, false-positive pregnancy tests do show up during the course of an injectable hCG diet. 2. MATERIALS AND METHODS Approval was obtained from the Weber State University Internal Review Board for Human Subjects prior to experimentation. Fifteen women participated in this study after they agreed to, and signed, an informed consent document. The women reported themselves as being non-menopausal and non-pregnant, and as never having had an hCG producing cancer. The women were in general good health (they had a pre-diet health examination performed by an outside organization to determine if they could participate), were allowed to participate in sexual intercourse, and were allowed to use contraceptives. Questionnaires were used before sample collections to determine whether or not the women¡¯s samples could be included in the study. The women were divided into two groups in order to include as many women as possible into the study. Group A consisted of nine women who had baseline sample collections taken prior to starting their hCG diet. Group B consisted of six women who had baseline sample collections
- 4. taken at least three days after ending their hCG diet. Both groups A and B had their experimental samples taken at least a week into their course of daily exogenous hCG injections. The Calorie intake of these women was unimportant to this study. The women injected themselves each morning with 0.2 mL of Novarel solution, concentrated to 1,000,000 mIU/mL. This means that the women each self-administered a total amount of 200,000 mIU of Novarel per day. Novarel is an exogenous-hCG drug that is approved by the Department of Food and Drug Administration (FDA). An FDA approved drug was used so that the reported concentration of the exogenous-hCG drug would be more reliable than that of a non-FDA-approved product. The baseline and experimental samples each consisted of one serum sample and one clean-catch urine sample that was collected around 6:00 PM (6-12 hours after their morning injection of exogenous hCG). The serum was collected using a Serum Separator Tube (SST) via standard phlebotomy and specimen-processing procedures. A sterile urine-cup was used for urine collection, and each woman was given instructions on how to perform a clean catch urine sample. No further preparation was made to the serum and urine samples. Testing of the serum samples for the presence of hCG was done using a clinical pregnancy test that had a sensitivity of 25 mIU/mL. The urine samples were tested for the presence of hCG using an over-the-counter dipstick pregnancy test that had a sensitivity of 13 mIU/Ml8 . These two pregnancy tests were used to simulate the common qualitative pregnancy tests that are used in the United States. Women who tested positive for hCG during baseline testing were excluded from the study. Women, who tested negative for hCG during baseline testing, remained in the study, and their experimental pregnancy test results are reported in the next section. 3. RESULTS Fifteen women were evaluated in this study. All fifteen women returned false-positive serum pregnancy test results. Fourteen of the women returned false-positive urine pregnancy test results. One woman returned a negative urine pregnancy test result. Table 1. number of false-positive and true-negative experimental pregnancy tests results hCG Diet Participants¡¯ Experimental Pregnancy Test Results Test Results Serum (25 mIU/mL) Urine (13mIU/mL) False-positive 15 14 True-negative 0 1 4. DISCUSSION None of the baseline pregnancy tests displayed positive results. This means that at about 6:00 PM all women that participated within the study naturally did not have elevated biological-hCG
- 5. levels sufficient to elicit a false-positive reaction. When collection was taken at about 6:00 PM during the women¡¯s course of exogenous-hCG injections, all serum samples tested positive for pregnancy. Fourteen of the 15 urine samples returned positive for pregnancy. This means that at the same time of day something caused these women to obtain positive pregnancy test results. The cause is believed to be the daily morning injection of 200,000 mIU of exogenous-hCG. All hormones have metabolism half-lives. Since hCG is a hormone it is degraded over time within a participant¡¯s body over the course of a day, which means hCG concentrations should be highest right after exogenous-hCG injection and lowest right before the next morning hCG injection. There is a possibility that if the participants were tested for pregnancy prior to their next morning hCG injection that the pregnancy tests would have returned negative, but this was not tested. The false-positive pregnancy test results obtained in this study do indicate that the daily injectable hCG diet regimen of 200,000 mIU creates an environment that elicits unreliable pregnancy test results. The information gathered by this study would be useful for physicians and those who participate in injectable hCG diets. If a physician were to know that his or her patient was on an hCG injection based diet, and that this sort of diet influences the results of pregnancy tests, then the physician would know that the patient needs to stop the diet for at least three days to avoid obtaining inaccurate pregnancy test results. Participants of the injectable hCG diet, and their physicians are advised to not trust pregnancy test results until they have stopped the hCG injections for at least three days. This would help avoid the possibilities of an emotional rollercoaster caused by a positive pregnancy test when the test was really a false-positive. Only injectable exogenous-hCG was examined in this experiment and because of this it can only be assumed that the use of oral exogenous-hCG would provide the same results. There is a possibility that oral administration of hCG provides results opposite of those found in this study. 5. CONCLUSION Injecting 200,000 mIU of exogenous-hCG per day into a woman will create an environment that elicits unreliable, false-positive pregnancy test results. 6. ACKNOWLEDGEMENTS The authors wish to express their appreciation to Jenny Perkins and her Dream a Thinner Dream hCG Diet Clinic. Jenny provided the best environment for the study to take place. The authors also express their thanks to the Weber State University Office Undergraduate Research (WSU OUR) for funding the entire project. Thanks are also expressed to Gary Nielsen, who was the best mentor any student could ever have. Gary is retiring from teaching at WSU April 20, 2012 and will be missed by his fellow students.
- 6. 7. REFERENCES 1. Yoshimoto, Y.; Wolfsen, A. R.; & Odell, W. D. (1979). Glycosylation, A Variable in the Prodection of hCG by Cancers. American Journal of Medicine, 414-420. 2. Shalit, A; Jaschevatzky, OE; Kampf, D; Leiserowitz, DM; & Gr¨¹nstein S. (1980). Human chorionic gonadotropin in intrauterine device users. International Journal Of Fertility, 134-136. 3. Simeons, A. (1954). The action of chorionic gonadotropin in the obese. Lancet, 946, 947. 4. Novarel? (Chorionic Gonadotropin for Injection, USP) [package insert 2011]. Quebec, Canada; DRAXIS Specialty Pharmaceuticals Inc. 5. Cole, L. A. (2009). New discoveries on the biology and detection of human chorionic gonadotropin. Reproductive Biology and Endocrinology, 8-45. 6. Sure-Vue? Serum/Urine hCG [package insert, 2008]. Houston, TX; Fischer Scientific Healthcare. 7. Noci, I.; Saltarelli, O.; Coccia, E.; Messo, A.; Livi, C.; Massi, G. B.; & Messeri, G. (1987). Interference of exogenous HCG on pregnancy tests. Acta Eur Fertil, 391-393. 8. Butler, S. A.; Khanlian, S. A.; & Cole, L. A. (2001). Detection of Early Pregnancy Forms of Human Chorionic Gonadotropin by Home Pregnancy Test Devices. Clinical Chemistry, 2131- 2136.