Characteristics of the medicine
Ovitrelle comes in the form of a powder and solvent to be mixed to make a solution for injection. It is also available as a solution for injection in a pre-filled syringe. The active ingredient contained in Ovitrelle is choriogonadotropin alfa.
Therapeutic indications
Ovitrelle is indicated in women undergoing treatment for ovarian stimulation, ovulation induction (release of oocytes) and development of the special ovarian structure (the corpus luteum) which promotes pregnancy. It can also be used in women undergoing fertility treatment (assisted reproductive techniques such as fertilization in vitro - IVF) and in anovulatory (i.e., who do not produce oocytes) or oligo-ovulatory (i.e., that produce too few oocytes) patients.
Ovitrelle can only be obtained with a prescription.
How to use
Ovitrelle treatment should be supervised by a doctor experienced in the treatment of fertility problems. Ovitrelle is administered subcutaneously (under the skin). The powder should be mixed immediately before use with the solvent provided.
Administer one vial of Ovitrelle (250 micrograms) 24 to 48 hours after ovarian production of sufficiently mature follicles (oocytes ready for ovulation). In women undergoing fertility treatment this usually coincides with the 24 - 48 hours following term. previous ovarian stimulation treatment (for example, administration of FSH, follicle stimulating hormone, or hMG, human menopausal gonadotropin).
Mechanisms of action
The active ingredient contained in Ovitrelle, choriogonadotropin alfa, reproduces the natural hormone hCG or human chorionic gonadotropin, otherwise known as pregnancy hormone. The hCG is present in the body during pregnancy, helping to maintain the corpus luteum and, consequently, of the pregnancy itself. In fertility treatments, hCG is used because it is similar to luteinizing hormone (LH), which is the hormone that induces ovulation during the menstrual cycle. The choriogonadotropin alfa in Ovitrelle is produced by a method known as 'recombinant DNA technology'; that is, it is obtained from a cell in which a gene (DNA) has been introduced which makes it capable of producing human chorionic gonadotropin.
Studies carried out
The efficacy of Ovitrelle has mainly been studied in women undergoing fertility treatment (1140 patients). Two strengths, 250 micrograms and 500 micrograms, were tested, evaluating the effectiveness of Ovitrelle on the basis of the amount of oocytes released. Ovitrelle was compared with the natural hormone hCG taken from urine. A study was also dedicated to women who are unable to ovulate.
Benefits found following the studies
Ovitrelle was as effective as urinary-derived hCG for producing oocytes; the efficacy of the 250 microgram dose was the same as the 500 microgram dose. In anovulatory women, ovulation was found in 91.9% of patients treated with Ovitrelle.
Associated Risks
Among the most frequent side effects (seen in 1 - 10 out of 100 patients) are: local reaction / pain at the injection site, headache, tiredness, vomiting, nausea (feeling unwell), abdominal pain (abdominal pain) and ovarian hyperstimulation syndrome (eg nausea, weight gain, diarrhea). Ovarian hyperstimulation syndrome is characterized by an "abnormal response to ovarian treatment, particularly when using drugs for ovarian stimulation. Do not administer Ovitrelle to patients with hypersensitivity (allergy) to choriogonadotropin alfa or other ingredients, or in people with cancer. hypothalamus and pituitary, or carcinoma of the ovary, uterus or breast. Do not use when a response cannot be obtained (for example in the case of ovarian failure). Do not administer to patients with ovarian enlargement or cysts not due to polycystic ovary syndrome, in case of unexplained vaginal bleeding or ectopic pregnancy within the previous 3 months. Ovitrelle must not be used in women with active thromboembolic disorders (blood clots). For the complete list of restrictions, see the package insert.
Reasons for approval
The Committee for Medicinal Products for Human Use (CHMP) decided that Ovitrelle's benefits outweigh its risks for women who need to ovulate before undergoing fertility treatment, and in anovulatory or oligo-ovulatory women and has therefore recommended the release of the marketing authorization for Ovitrelle.
Further information
On February 2, 2001, the European Commission granted Serono Europe Limited a "Marketing Authorization" for Ovitrelle, valid throughout the European Union. The "Marketing Authorization" was renewed on February 2, 2006.
For the full Ovitrelle evaluation (EPAR) version, click here
Last update of this summary: 10-2006.
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