Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.

Puregon (Organon)
ampoules containing 50, 100 and 150 IU
Indication: infertility

Some infertile women require treatment with gonadotrophins to stimulate follicular development. Follitropin is a recombinant human follicle stimulating hormone(FSH) that may supersede the existing products which are derived from urine.

The hormone is produced from genetically engineered Chinese hamster oocytes. It has an amino acid sequence identical to human FSH. Clinical trials suggest that follitropin beta is at least as effective as urinary gonadotrophins.

Follitropin can be used to stimulate follicular development in women with anovulatory infertility. After finding the optimum daily dose, each patient is monitored until pre-ovulatory conditions are reached. Follitropin is then stopped and ovulation induced with human chorionic gonadotrophin (HCG). The hormone can also be used to produce controlled ovarian hyper stimulation. This prepares follicles for retrieval in assisted reproduction programs.

Follitropin beta has also been approved for use in males with deficient spermatogenes is due to hypogonadotrophic hypogonadism. The injections are given 2 or 3 times per week and HCG is given simultaneously. Treatment usually has to continue for at least 3 months before there is an improvement in spermatogenesis.

The main adverse effect in women is unplanned ovarian hyper stimulation. This can result in multiple pregnancies.