Ovidrel

Ovidrel is a prescription hCG trigger shot used during IVF and other fertility treatments to bring eggs to final maturity before egg retrieval or ovulation. It contains choriogonadotropin alfa, a lab-made (recombinant) form of human chorionic gonadotropin (hCG). The Ovidrel injection comes as a ready-to-use 250 mcg prefilled syringe that you can give yourself under the skin of your stomach.

Ovidrel is used only in women. It is made by EMD Serono.

Ovidrel is used to induce ovulation in women undergoing fertility treatment. It has 2 FDA-approved uses:

• IVF and assisted reproductive technology (ART). Ovidrel brings eggs to final maturity (final follicular maturation) before they are collected for in vitro fertilization and embryo transfer. It is used in women who have already had medication to stop their natural hormone surges (pituitary desensitization) and follicle-stimulating hormone (FSH) to grow several eggs.
• Ovulation induction. Ovidrel triggers ovulation and supports pregnancy in women who do not ovulate on their own (anovulation). It is used only when the cause of infertility is functional, and not caused by ovaries that have stopped working (primary ovarian failure).

Before treatment, your provider should do a full gynecologic and hormone evaluation, rule out pregnancy, and check your partner's fertility. Women with blocked fallopian tubes should use Ovidrel only as part of an IVF program.

Ovidrel works by copying the natural surge of luteinizing hormone (LH) that normally triggers ovulation. It binds to LH/hCG receptors in the ovary and tells mature follicles to finish developing, release the egg, and start making progesterone.

Ovidrel is made in Chinese hamster ovary cells using recombinant DNA technology. Its structure and activity are very similar to hCG from the placenta and urine.

After an injection under the skin, Ovidrel reaches its highest level in the blood in about 12 to 24 hours. Its half-life is about 29 hours, which means half of the dose is cleared from your body in that time.

The Ovidrel trigger shot is given 1 day after your last dose of FSH (follicle stimulating) medicine, once your follicles are ready. The usual dose is 250 mcg, given once.

Your fertility team decides the timing using blood tests for estradiol and transvaginal ultrasound scans of your ovaries. Follow their instructions exactly, because the time you inject is usually planned around your egg retrieval or intercourse.

Your provider will not give Ovidrel if your ovaries have responded too strongly. Signs include many follicles growing, enlarged ovaries, or very high estradiol levels. Holding the trigger shot in these cases lowers the risk of ovarian hyperstimulation syndrome (OHSS).

Ovidrel is injected under the skin (subcutaneously) of your stomach using the prefilled syringe. You can give the injection yourself after your healthcare provider shows you how, and there is no mixing needed. Follow these Ovidrel injection instructions from the prescribing information:

• Wash your hands well with soap and water.
• Clean the injection site. Sit or lie down comfortably. Clean an area of skin on your stomach with an alcohol wipe and let it air-dry.
• Give the injection. Carefully remove the needle cap. Do not touch the needle or let it touch any surface. Inject the prescribed dose as your doctor, nurse, or pharmacist directed.
• Withdraw the needle. Put the needle and syringe in a sharps (safety) container. Place gauze over the site and press gently if there is bleeding. If bleeding does not stop within a few minutes, cover the site with clean gauze and a bandage.
• Clean up. Each syringe is for a single injection. Throw away any medicine left in the syringe, and never reuse injection supplies.

Ovidrel is approved for subcutaneous use only. In the US, Ovidrel comes only as a prefilled syringe.

What are the most important warnings for Ovidrel?

Ovidrel can cause ovarian hyperstimulation syndrome (OHSS) and multiple pregnancy, so it should be used only by doctors experienced in treating infertility. Your ovaries will be monitored closely with blood tests and ultrasound during treatment.

• Ovarian hyperstimulation syndrome (OHSS). OHSS causes fluid to build up quickly in the belly, chest, and sometimes around the heart. Severe OHSS can develop within 24 hours to several days and become a medical emergency. In clinical trials, OHSS happened in 1.7% of women using Ovidrel 250 mcg for IVF and 3.0% of women using it for ovulation induction. OHSS is most often worst 7 to 10 days after treatment and may be more severe and last longer if you become pregnant. You should be followed for at least 2 weeks after your trigger shot.
• Ovarian enlargement. Mild to moderate swelling of the ovaries, with bloating or belly pain, can happen with FSH and hCG treatment. It usually goes away without treatment within 2 to 3 weeks.
• Multiple pregnancy. Twins or more were common in clinical trials. Multiple births happened in 30.9% of live deliveries in the IVF studies and 13.3% in the ovulation induction study. In IVF, the risk depends on how many embryos are transferred.
• Blood clots. Blood clots in the arteries or veins can happen with hCG products, with or without OHSS. Tell your provider if you or a family member have had blood clots.
• Allergic reactions. Allergic reactions, including anaphylaxis and mild skin rashes, have been reported since Ovidrel came on the market.
• Liver test changes. Mild rises in a liver enzyme (ALT) were seen in 3% of women using Ovidrel 250 mcg in clinical trials. The clinical importance of this is not known.

Get medical help right away if you have severe pelvic pain, nausea, vomiting, sudden weight gain, shortness of breath, or are urinating less than usual.

Who should not use Ovidrel?

You should not use Ovidrel if you:

• are pregnant
• have had an allergic reaction to hCG products or any ingredient in Ovidrel
• have primary ovarian failure (ovaries that no longer work)
• have a thyroid or adrenal problem that is not controlled
• have an uncontrolled brain lesion, such as a pituitary tumor
• have abnormal uterine bleeding that has not been checked by a doctor
• have an ovarian cyst or enlarged ovary that has not been checked by a doctor
• have a tumor of the reproductive organs that is sensitive to sex hormones

What should I tell my healthcare provider before using Ovidrel?

Tell your healthcare provider about all your health conditions, especially if you:

• or a family member have had blood clots
• have abnormal uterine bleeding or other signs of a problem with the lining of the uterus (endometrium)
• have blocked fallopian tubes
• have liver problems
• have kidney problems

The safety of Ovidrel has not been studied in people with kidney or liver problems.

Pregnancy. Do not use Ovidrel if you are already pregnant. Your provider should rule out pregnancy before you start treatment.

Breastfeeding. It is not known if Ovidrel passes into breast milk. Talk with your provider before using Ovidrel while breastfeeding.

Lab tests. hCG can affect some hormone blood tests, especially LH tests. Tell the lab that you are using Ovidrel.

What are the side effects of Ovidrel?

The most common Ovidrel trigger shot side effects are injection site pain and bruising, belly pain, nausea, and vomiting. Injection site reactions were about half as common with Ovidrel as with urine-derived hCG in clinical trials (14.6% vs 28%).

Rates are for Ovidrel 250 mcg, for side effects seen in at least 2% of women, whether or not caused by the medicine.

Less common side effects (under 2%) included breast pain, bloating, diarrhea, headache, dizziness, hot flashes, back pain, fever, rash, mood changes, trouble sleeping, and vaginal bleeding or discomfort.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, or swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have signs of OHSS, such as severe pelvic pain, nausea, vomiting, sudden weight gain, shortness of breath, or urinating less than usual.

This is not a complete list of side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs interact with Ovidrel?

No drug interaction studies have been done with Ovidrel. Tell your healthcare provider about all the medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Ovidrel can affect pregnancy test results. Because it contains hCG, the hormone that pregnancy tests detect, a test taken too soon after your trigger shot may show a false positive. Ask your fertility team when to test.

How should I store Ovidrel?

Store Ovidrel in the refrigerator at 36°F to 46°F (2°C to 8°C) until the expiration date on the syringe or carton. You may keep it at room temperature, up to 77°F (25°C), for up to 30 days, but you must use it within those 30 days.

• Keep the syringe in its original package to protect it from light.
• Throw away any unused medicine after your injection.

What does Ovidrel contain?

Each Ovidrel PreFilled Syringe delivers 250 mcg of choriogonadotropin alfa in 0.5 mL of liquid.

• Active ingredient: choriogonadotropin alfa (recombinant hCG)
• Inactive ingredients: mannitol, phosphoric acid, L-methionine, poloxamer 188, sodium hydroxide, and water for injection

Manufacturer: EMD Serono, Inc. NDC 44087-1150-1.

Frequently asked questions

Where do you inject Ovidrel?

Ovidrel is injected under the skin of your stomach. Clean the skin with an alcohol wipe and let it dry before you inject. Your provider will show you the right spot.

How long does Ovidrel stay in your system?

Ovidrel has a half-life of about 29 hours, so about half of the dose is gone from your blood a little over a day after your injection. It reaches its highest level in your blood about 12 to 24 hours after the injection.

Can Ovidrel cause a false positive pregnancy test?

Yes. Ovidrel contains hCG, the same hormone that pregnancy tests detect, so a test taken too soon after your trigger shot may be positive even if you are not pregnant. The prescribing information does not say how long this lasts. Ask your fertility team when to take a pregnancy test.

How do I know if I ovulated after the Ovidrel trigger shot?

Your provider confirms ovulation using signs that your body is making progesterone, often together with an ultrasound of your ovaries. Signs of ovulation include:

• a rise in your basal body temperature
• a rise in progesterone on a blood test
• a period that starts after your basal body temperature has gone up
• ultrasound signs, such as a collapsed follicle or fluid behind the uterus

Does Ovidrel need to be refrigerated?

Yes, Ovidrel should be kept in the refrigerator until the expiration date. You can store it at room temperature, up to 77°F (25°C), for up to 30 days, but it must be used within those 30 days.

How well does Ovidrel work?

In clinical trials, Ovidrel 250 mcg worked as well as urine-derived hCG. In the ovulation induction study, 91.9% of women ovulated and 22% had a clinical pregnancy. In the 2 IVF studies, the clinical pregnancy rate per treatment cycle was 35.1% and 33%.

Is Ovidrel the same as hCG?

Ovidrel is hCG, but it is made in a lab using recombinant DNA technology rather than purified from urine. Its activity is comparable to hCG from urine and the placenta. For a side-by-side comparison with a urine-derived product, see Pregnyl vs Ovidrel.

Can men use Ovidrel?

No. Ovidrel is approved only for women having fertility treatment. It is not approved for use in males or children.

References

• EMD Serono, Inc. Ovidrel PreFilled Syringe (choriogonadotropin alfa injection), prescribing information. BLA 021149. Revised 12/2023.