INTRODUCTION

THIS INFORMED CONSENT (THE “CONSENT”) FOR HCG (PREGNYL) SETSFORTH THE TERMS AND POLICIES FOR THE CLINICAL SERVICES PROVIDED BY SUPERPOWERMEDICAL GROUP OF CA PC, A CALIFORNIA PROFESSIONAL MEDICAL CORPORATION, ANDOTHER THIRD-PARTY MEDICAL GROUPS (COLLECTIVELY, THE “MEDICAL GROUPS”) THROUGHTHE ONLINE TECHNOLOGY PLATFORM (“PLATFORM” OR “SUPERPOWER PLATFORM”), WHICH ISOWNED AND OPERATED BY SUPERPOWER HEALTH, INC. (“SUPERPOWER”).

The purpose of this consent is to provide you withinformation about the risks, benefits, and safety considerations associatedwith hCG (brand name: Pregnyl) in order for you to make an informed decision asto whether or not to proceed with treatment, as well as to obtain youragreement to adhere to the treatment protocol as prescribed by your MedicalGroup healthcare provider (“Healthcare Provider”). Please read this formcarefully and ask any questions you have before signing.

GENERAL INFORMATION

Human Chorionic Gonadotropin (hCG) is a hormoneproduced in the placenta during pregnancy. Commercially produced hCG (e.g.,Pregnyl) is FDA-approved for certain indications, such as fertility treatments,by helping stimulate ovulation in females and supporting testicular function inmales. hCG may also be prescribed off-label for other conditions as determinedby your Healthcare Provider.

FDA Status: Pregnyl (hCG) is FDA-approved for specific medical uses (e.g., treatment of infertility, hypogonadism). If you are prescribed hCG for any purpose not explicitly approved by the FDA, you should be aware that such use is considered off-label.
Mechanism of Action:
- In females, hCG can mimic luteinizing hormone (LH), helping trigger ovulation and support the corpus luteum.
- In males, hCG can help maintain or boost testosterone production by acting on the Leydig cells of the testes.
- Off-label uses include certain endocrine or metabolic protocols, the effectiveness and safety of which may not be established by the FDA.

As with any therapy, there are potential benefits andrisks.

POTENTIAL BENEFITS OF hCG

Fertility Support: Can help induce or regulate ovulation in females and support sperm production in males.
Hormone Regulation: May help increase testosterone levels in males with certain forms of hypogonadism.
Off-Label Applications: Potential improvements in certain metabolic or weight management programs, although scientific evidence varies, and these indications are not FDA-approved.

Individual results will vary, and effectiveness dependson your overall health and adherence to the prescribed protocol.

POTENTIAL SIDE EFFECTS OF hCG

Possible side effects include, but are not limited to:

Injection Site Reactions: Pain, redness, swelling, or bruising at the injection site.
Hormonal Fluctuations: Headaches, mood changes, irritability, fatigue, or restlessness.
Ovarian Hyperstimulation Syndrome (OHSS): In females undergoing fertility treatment, there is a risk of OHSS, which may cause enlarged ovaries, abdominal pain, and other complications.
Gynecomastia (Males): Enlargement or tenderness of breast tissue.
Allergic Reactions: Rare but may include rash, itching, swelling, dizziness, or difficulty breathing.

This is not an exhaustive list. If you experience anysevere or persistent side effects, notify your Healthcare Provider immediately.

TREATMENT PROTOCOL

Your Healthcare Provider will determine the specific dosage,timing, and route of administration based on your medical history, currenthealth status, and treatment goals. hCG (Pregnyl) is typically administered viasubcutaneous or intramuscular injection.

Standard Usage Instructions

Dosage & Frequency: Follow your Healthcare Provider’s prescription exactly. Do not alter your dosage unless instructed.
Injection Technique: Your Healthcare Provider may instruct you on self-injection techniques, including proper needle handling and disposal.
Monitoring: Regular follow-up may be required. This may include blood tests, ultrasounds (for fertility protocols), or other evaluations to monitor your body’s response.

Adherence

It is critical to follow your prescribed treatment plan andto communicate any new or worsening symptoms to your Healthcare Providerpromptly.

ALTERNATIVES TO hCG

Depending on your condition or treatment goals, alternativesto hCG may include:

Other Fertility Treatments: Medications such as clomiphene citrate, letrozole, or assisted reproductive technologies (e.g., IVF).
Hormone Replacement Therapies: Testosterone therapy or other approved medications, as indicated.
Lifestyle Interventions: Diet, exercise, weight management, and stress reduction, which can influence hormone levels and overall health.

These alternatives may or may not provide the same benefitsas hCG therapy and should be discussed with your Healthcare Provider.

CONTRAINDICATIONS

You should not use hCG if:

You have a known allergy or hypersensitivity to hCG or any of its components.
You have certain hormone-sensitive tumors (e.g., prostate cancer, some breast cancers) or undiagnosed uterine bleeding.
You are pregnant, intending to become pregnant (outside of prescribed fertility protocols), or breastfeeding without consulting your Healthcare Provider.
Your Healthcare Provider deems it clinically inappropriate based on your medical history or current condition.

ADDITIONAL SAFETY INFORMATION

Medication & Supplement Disclosure: Inform your Healthcare Provider of all prescription drugs, over-the-counter medications, and supplements you are taking to avoid potential interactions.
Storage & Handling: If self-injecting, store hCG (Pregnyl) as instructed (e.g., in a refrigerator if required) and follow all guidelines for safe handling and needle disposal.
Monitor for Adverse Events: Contact your Healthcare Provider immediately if you experience unusual or severe side effects, signs of allergic reactions, or other concerning symptoms.

USE OF TELEHEALTH

Your Clinical Services may be provided via telehealth.Telehealth involves the use of electronic communication for diagnosis,treatment, and follow-up care. By agreeing to this Consent, you acknowledge thefollowing:

Telehealth offers improved access to care but may limit the ability to perform a full physical examination.
Potential risks include delays due to technical issues and rare breaches of data security.
You must be physically located in the state where your Healthcare Provider is licensed during telehealth visits, unless otherwise permitted by law.

INFORMED CONSENT & ADHERENCE TO TREATMENT PLAN

By signing this informed consent, you acknowledge that you:

Have read and understood the information provided about hCG (Pregnyl), including its risks, benefits, and safety considerations. You understand that hCG is FDA-approved for certain uses and may be prescribed off-label, for which safety and efficacy may not be fully established.
Agree to adhere to the treatment protocol as prescribed by your Healthcare Provider and report any severe side effects or concerns promptly.
Understand that there are no guarantees or assurances regarding treatment outcomes.
Certify that you have disclosed all relevant health information, including allergies, medications, and medical history, to your Superpower Healthcare Providers.

CERTIFICATION OF CONSENT

By clicking “I AGREE” or signing below, you certify that:

You have read and understood this entire Informed Consent.
You have had the opportunity to ask questions, and all your questions have been answered to your satisfaction.
You freely and voluntarily accept all risks associated with hCG (Pregnyl) therapy and consent to proceed with treatment.

MEMBER NAME: ___________________________
SIGNATURE: ______________________________
DATE: ____________________________________

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Informed Medical Consent for Pregnyl (hCG)