Ovaleap in IVF: Administration, Costs & Possible Side Effects

By MD, PhD, MSc (gynecologist), BSc, MSc (embryologist) and (invitra staff).
Last Update: 03/24/2020

Ovaleap is a hormonal drug used in assisted reproduction treatments such as in vitro fertilisation (IVF).

Specifically said, Ovaleap contains the follicle-stimulating hormone (FSH) and is indicated for controlled ovarian stimulation and ovulation induction.

The injection of Ovaleap is easily done by using a pen which should be kept in the refrigerator.

Definition and purpose of Ovaleap

Ovaleap is a drug used in assisted reproduction that was firsrt authorised in Europe in September 2013.

Its active ingredient is alpha-folitropin, a gonadotropin obtained in a recombinant way in the laboratory.

This means that Ovaleap is a biosimilar medicine to the original Gonal-f.

A biosimilar medicinal product is a biological medicinal product, produced in accordance with specific requirements laid down by the European Medicines Agency with regard to quality, efficacy and safety, and which has been shown to be comparable to the reference innovative medicinal product, after the expiry of the patent.

The difference with a generic drug is that the latter are drugs that have the same qualitative and quantitative composition in active ingredients and the same pharmaceutical form as the original, whereas biosimilar refers to products synthesised in a biological form that are not identical to the original.

The function of the hormone folitropin alpha is to cause multiple and controlled follicular development in the woman's ovaries. In this way, it is possible to obtain several mature eggs that will later be extracted and fertilised in the IVF laboratory.

In the case of artificial insemination (AI), only one or two mature follicles are needed to prevent multiple pregnancy. Therefore, the gynecologist will advise the woman to take a lower dose of Ovaleap.

Packaging and cost

The Ovaleap presentation format is a multidose cartridge that already comes with the solution ready to be injected with the device known as Ovaleap Pen. Additionally, the medicine box also contains disposable needles.

Depending on the hormone dose of the cartridge, there are 3 types of Ovaleap presentation:

Ovaleap 300
each cartridge contains 300 IU (equivalent to 22 micrograms) of alpha-folitropin in 0.5 ml of solution. It costs £141.00 in the UK.
Ovaleap 450
each cartridge contains 450 IU (equivalent to 33 micrograms) of alpha-folitropin in 0.75 solution. It costs around £105.00 in the UK.
Ovaleap 900
each cartridge contains 900 IU (equivalent to 66 micrograms) of alpha-folitropin in 1.5 ml of solution. It costs around £300.00.

The other components of Ovaleap are the following: sodium dihydrogen phosphate dihydrate, sodium hydroxide, mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride and water for the injectable preparations.

Indications and efficiency

Ovaleap is indicated for ovarian stimulation in assisted reproduction technology, as well as in men who do not produce FSH to help sperm production.

In terms of efficiency, Ovaleap is similar to other types of gonadotropins as demonstrated by the studies presented for demonstration of equivalence.

However, some studies point to a greater cost-effectiveness of the reference product Gonal-f with respect to its biosimilars, although more data would be needed to confirm this finding.

How do I inject Ovaleap?

Ovaleap is administered by subcutaneous injection with a pen (the Ovaleap Pen) to which the cartridge with the medicine and the disposable needle are attached.

The Ovaleap Pen must be purchased separately, as it does not come in the box of the medication. Normally, it is the clinic itself that provides the patient with this device for free.

Next, let's look at the steps to follow for the Ovaleap injection.

Preparation of the Ovaleap Pen

The Ovaleap pen comes in a large green case. The following instructions must be followed to attach the cartridge with the medication to the Ovaleap Pen:

  1. Uncover the pen and unscrew the top.
  2. Insert the cartridge so that the grey rubber is at the top and screw the pen back in.
  3. Place the subcutaneous needle and remove the protections.
  4. Remove any air left inside the pen. To do this, select a dose of 12.5 by turning the wheel on top of the boom.
  5. Once the selected dose appears in the boom window, discharge is performed by pushing down the green intermediate piece of the boom (injection button).

After all this has been done, you will be able to see one or two drops of the medicine come out of the needle and then the Ovaleap Pen will be ready for the injection.

Subcutaneous injection

After the preparation of the Ovaleap Pen, it is necessary to continue with the administration of the drug in the woman's abdomen:

  1. Select the dose indicated by the gynaecologist with the wheel at the top until it appears in the window of the pen.
  2. Disinfect the injection area with alcohol.
  3. Pinch the abdomen so that a fold forms.
  4. Insert the entire needle into the skin and discharge the dose by pushing down on the injection button.
  5. Once the discharge is done, remove the pen and press the area with cotton and alcohol.
  6. Remove the needle and discard it in a suitable container.
  7. Replace the pen cap to protect it from light.

Side effects

The use of Ovaleap can lead to more or less frequent adverse reactions of varying severity.

In women

The most common side effects of Ovaleap in women are the following:

  • Headache
  • Ovarian Cysts
  • Reactions at the injection site, such as pain, redness, bruising, swelling, or irritation
  • Abdominal pain and distention
  • Nausea, vomiting, and diarrhea
  • Mild or moderate ovarian hyperstimulation syndrome (OHS)

Other less frequent or very rare adverse reactions are thromboembolism, anaphylactic reactions, worsening of asthma or severe OHS.

In men

For men using Ovaleap to treat hypogonadotropic hypogonadism, they may also experience frequent side effects such as acne, weight gain, gynecomastia or varicocele.

Other more rare adverse reactions are worsening of asthma and hypersensitivity reactions such as shock and anaphylactic reactions.

Assisted procreation, as any other medical treatment, requires that you rely on the professionalism of the doctors and staff of the clinic you choose. Obviously, each clinic is different. Get now your Fertility Report, which will select several clinics for you out of the pool of clinics that meet our strict quality criteria. Moreover, it will offer you a comparison between the fees and conditions each clinic offers in order for you to make a well informed choice.

All the information published in this article has been extracted from the Vademecum (a treaty containing the composition, indications, side effects, etc. of each of the existing medicines on the market)

FAQs from users

What are the benefits of using Ovaleap for ovarian stimulation?

By Blanca Paraíso MD, PhD, MSc (gynecologist).

Ovaleap's main advantage is its administration device.

In a recent study, 402 patients from different countries were surveyed to evaluate what they considered to be the most important characteristics of devices for self-administration of medication in assisted reproduction treatments. Of the 6 most valued characteristics, Ovaleap has the device with the highest number of them, 5 in total (type of device: multi-dose pen, with dial-back function, possibility of increasing the dose in small amounts, release button for injection and visibility of the remaining medication in the cartridge).

Only the Puregon device outperformed it in one feature, the daily injection volume, being 0.18ml while with Ovaleap it is 0.25ml.

How much does Ovaleap cost?

By Zaira Salvador BSc, MSc (embryologist).

The price of the Ovaleap drug depends on the dose purchased. For example, Ovaleap 300 costs £100, while Ovaleap 450 is priced at £150. Finally, the drug with the highest hormone dose, Ovaleap 900, costs £300.

When do women need to use Ovaleap?

By Zaira Salvador BSc, MSc (embryologist).

Ovaleap is a medicine used in assisted reproduction treatments in the following cases:

  • Women who suffer from anovulation or who are diagnosed with polycystic ovary syndrome (PCOS).
  • Women undergoing ovarian stimulation during IVF
  • Women with severe LH and FSH deficiency. In this case, Ovaleap is administered in combination with an LH preparation for ovarian stimulation.

How should I store Ovaleap?

By Zaira Salvador BSc, MSc (embryologist).

Ovaleap must be kept in the refrigerator in its original packaging to protect it from light. Before opening and during its 2 year validity period, Ovaleap can be taken out of the fridge, without being refrigerated again, for up to 3 months. In this case, the storage temperature must not exceed 25°C.

Once Ovaleap has been opened after its first administration, the cartridge must be kept inside the pen and stored for a maximum period of 28 days at a temperature below 25ºC. However, it is more advisable to keep the pen with the medication in the refrigerator at a temperature between 2 and 8ºC until it is used again.

Suggested for you

If you would like more information on the drugs used in assisted reproduction treatments, do not miss out on the following article: What medications are used for ovarian stimulation?

We have mentioned that Ovaleap is a biosimilar drug to Gonal-f. If you want to read more about this drug, you can access the following post: Gonal-f injection for IVF- uses, dosage, price & side effects.

Our editors have made great efforts to create this content for you. By sharing this post, you are helping us to keep ourselves motivated to work even harder.

References

Spanish Agency of Medicines and Health Products. CIMA. Ovaleap 300 UI / 0.5 ml injectable solution. REGISTER No: 113871001. Brochure: user information. (Link)

Spanish Agency of Medicines and Health Products. CIMA. Ovaleap 450 UI / 0,75 ml injectable solution. REGISTER No: 113871002. Brochure: user information. (Link)

Agencia Española de Medicamentos y Productos Sanitarios. CIMA. Ovaleap 900 UI / 1,5 ml solución inyectable. (ver)

European Medicines Agency. Ovaleap: EPAR - Product Information. Última actualización: 13/12/2018 (Link)

Gizzo S. A cost-effectiveness modeling evaluation comparing a biosimilar follitropin alfa preparation with its reference product for live birth outcome in Germany, Italy and Spain. J Med Econ. 2018 Nov;21(11):1096-1101.

Zitoun P. Analysis of patient and nurse preferences for self-administered FSH injection devices in select European markets. Int J Womens Health. 2019 Jan 7;11:11-21.

FAQs from users: 'What are the benefits of using Ovaleap for ovarian stimulation?', 'How much does Ovaleap cost?', 'When do women need to use Ovaleap?' and 'How should I store Ovaleap?'.

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Authors and contributors

 Blanca Paraíso
Blanca Paraíso
MD, PhD, MSc
Gynecologist
Bachelor's Degree in Medicine and Ph.D from the Complutense University of Madrid (UCM). Postgraduate Course in Statistics of Health Sciences. Doctor specialized in Obstetrics & Gynecology, and Assisted Procreation. More information about Blanca Paraíso
License: 454505579
 Zaira Salvador
Zaira Salvador
BSc, MSc
Embryologist
Bachelor's Degree in Biotechnology from the Technical University of Valencia (UPV). Biotechnology Degree from the National University of Ireland en Galway (NUIG) and embryologist specializing in Assisted Reproduction, with a Master's Degree in Biotechnology of Human Reproduction from the University of Valencia (UV) and the Valencian Infertility Institute (IVI) More information about Zaira Salvador
License: 3185-CV
Adapted into english by:
 Romina Packan
Romina Packan
inviTRA Staff
Editor and translator for the English and German edition of inviTRA. More information about Romina Packan

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