Download Informed Consent Form - San Diego Center for Integrative Medicine

San Diego Center for Integrative Medicine
Joseph Aiello, D.O.
Bronner Handwerger, N.D.
INFORMED CONSENT FOR HUMAN CHORIONIC GONADOTROPINS (HCG) THERAPY
I _________________________________________________ have consulted with the doctor on the use of HCG Therapy. As a
result, I have been directed toward information which will allow me to make an educated decision on whether HCG therapy
will be right for me.
I certify that this staff has made no representations or warranties as to the effectiveness or benefits, beyond their own personal
experience, of this therapy. I have chosen to undergo this therapy as a result of my own independent research and decision
making. Although the use of HCG has been reported to "cause weight loss" and the FDA has approved the use of HCG for
fertility treatments, at higher doses then those being used in my case, it/we make no such claim. I understand that I am
undergoing HCG therapy fully informed of potential side effects and aware that it is not approved for weight loss.
Use of HCG to treat obesity or for medical weight loss treatment is not an FDA approved use of this prescription drug. A
patient's physician may prescribe HCG for an unapproved medical purpose or off-label use of the drug because the use of this
drug has not generally caused serious adverse side effects when administered to patients for its approved use in treating
infertility. Allowing physicians professional discretion to prescribe HCG in treating obesity or for patient weight loss is not
based upon any governmental determination that HCG is effective for such use.
The information regarding the known side effects of HCG Replacement therapy have been thoroughly explained to me, and I
understand these could be; pain, rash, or swelling at the injection site if the Human form is being used which we are not. When
given subcutaneously, urinary HCG may cause more local swelling, redness or irritation, abdominal or pelvic pain, weight gain
breast discomfort, nausea and vomiting, abnormal uterine bleeding again with the human form.
What is the most important information I should know about HCG?
HCG is given as an injection into a muscle. If you use this medicine at home, your doctor, nurse, or pharmacist will give you
specific instructions on how and where to inject this medicine. Do not give yourself an injection if you do not understand these
instructions. Call your doctor, nurse, or pharmacist for help with injection instructions.
Using this medicine can increase your chances of having a multiple pregnancy (twins, triplets, quadruplets, etc. Although HCG
can help you become pregnant, this medication is in the FDA pregnancy category X. This means that using the medication once
you are pregnant can cause birth defects in the baby. Do not use this medication if you are pregnant. Tell your doctor right away
if you become pregnant during treatment.
Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS), especially
after the first treatment cycle using doses much higher then those used for non fertility treatments. OHSS can be a lifethreatening condition. Call your doctor right away if you have any symptoms of OHSS: severe pelvic pain, swelling of the
hands or legs, stomach pain and swelling, shortness of breath, weight gain, diarrhea, nausea or vomiting, and urinating less than
normal.
Other side effects, including allergic reactions, have been reported but with an incidence of less than 1%.
I have been instructed on how and where (Vastus lateralis or gluteus outer quadrant) to administer a sub Q or intramuscular
injection and release Dr. Aiello and Dr. Handwerger from all liability associated with me administering self injections
I certify that I have read this information and have freely elected to undergo HCG therapy and will follow the protocols and
requirements as set forth by Dr. Aiello and Dr. Handwerger and/or his agents.
Patient Signature_____________________________________________
Date_____________
10225 Austin Dr. #108, Spring Valley, Ca. 91978
Tel: 619 670-8028 Fax: 619 670-9675
www.drjosephaiello.com