Human Chorionic Gonadotrophin (hCG)

Treatment with Ovitrelle should be performed under the supervision of a physician experienced in the treatment of fertility problems. Before starting treatment the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated; in particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia and pituitary or hypothalamic tumours, and appropriate specific treatment given. There is no clinical experience with Ovitrelle in the treatment of other conditions (such as corpus luteum insufficiency or male conditions) and it is not indicated in these conditions. OHSS: adherence to the recommended dosage and regimen can minimise the risk of ovarian hyperstimulation; there is evidence that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and more protracted if pregnancy occurs, so if signs of ovarian hyperstimulation occur it is recommended that hCG be withheld and the patient advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days. Independent risk factors for OHSS include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotropins, high absolute or rapidly rising serum estradiol levels, previous episodes of OHSS, a large number of developing follicles and a large number of oocytes retrieved in ART cycles. Safety, efficacy and pharmacokinetics in renal or hepatic impairment have not been established. Traceability: record the name and batch number of the administered product. SPC section 4.4 was truncated at the source-fetch limit, so the warnings summarised here are not complete.