Author: Merck Serono Europe Limited


Long information

What is it?

Ovitrelle is a powder and solvent to be made up into a solution for injection. It is also available as a solution in a pre-filled syringe. Ovitrelle contains the active substance choriogonadotropin alfa.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Ovitrelle is used to treat women who have received treatment to stimulate their ovaries, to trigger ovulation (the release of eggs by the ovaries) and the development of a special structure on the ovary (the corpus luteum) that helps pregnancy. It can be used in women who are undergoing fertility treatment (assisted reproductive techniques, such as in vitro fertilisation), and in women who are anovulatory (do not produce eggs) or oligo-ovulatory (rarely produce eggs).
Ovitrelle can only be obtained with a prescription.

How is it used?

Treatment with Ovitrelle should be carried out by a doctor who has experience in the treatment of fertility problems. Ovitrelle is given subcutaneously (under the skin). The powder should be mixed with the solvent provided just before use. One vial of Ovitrelle (250 micrograms) is given 24 to 48 hours after the ovaries have produced follicle(s) that are mature enough (eggs ready for ovulation). In women undergoing fertility treatment, this is generally 24 to 48 hours after stopping the prior treatment for ovarian stimulation (such as a follicle stimulating hormone (FSH) or human menopausal gonadotrophin (hMG) preparation).

How does it work?

The active substance in Ovitrelle, choriogonadotropin alfa, is a copy of the natural hormone human chorionic gonadotropin (hCG), also known as the ?pregnancy? hormone, In the body, hCG is present during pregnancy, where it helps maintaining the corpus luteum, and consequently maintaining pregnancy. In fertility treatments, hCG is used because it is similar to luteinising hormone (LH), the hormone that triggers ovulation during the menstrual cycle. The choriogonadotropin alfa in Ovitrelle is produced by a method known as ?recombinant DNA technology?. It is made by a cell that has received a gene (DNA), which makes it able to produce human chorionic gonadotropin.

How has it been studied?

The effectiveness of Ovitrelle has been studied mainly in women undergoing fertility treatment (in 1,140 patients). Two doses were tested, 250 micrograms and 500 micrograms, and the effectiveness of

Ovitrelle was measured by looking at how many eggs could be released. Ovitrelle was compared to the natural hCG hormone that had been extracted from urine. One study has also been carried out in women who cannot ovulate.

What benefits has it shown during the studies?

Ovitrelle was as effective as urinary hCG in producing ovulation, and the 250 micrograms dose of Ovitrelle was as effective as the 500 micrograms dose. In anovulatory women, ovulation was seen in 91.9% of women treated with Ovitrelle.

What is the risk associated?

The most common side effects (seen in between 1 and 10 patients in 100) are a reaction or pain at the injection site, headache, tiredness, vomiting, nausea (feeling sick), abdominal (tummy) pain, and ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain, diarrhoea). Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment, especially when medicines to trigger ovulation have been used.
Ovitrelle should not be used in people who may be hypersensitive (allergic) to choriogonadotropin alfa or any of the other ingredients, or in patients with tumours of the hypothalamus and pituitary gland, ovary, uterus or breast. It should not be used when a response cannot be obtained (such as in ovarian failure). It should not be used in women when there is ovarian enlargement or cyst not due to polycystic ovarian disease, or unexplained vaginal bleeding, or who have had an ectopic pregnancy in the previous 3 months. Ovitrelle should also not be used in patients with active thrombo-embolic (clotting) disorders. For the full list of restrictions, see the Package Leaflet.

Why has it been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that Ovitrelle?s benefits are greater than its risks for women who need to ovulate before fertility treatment and in women who are anovulatory or oligo-ovulatory. They recommended that Ovitrelle be given marketing authorisation.

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