A prospective, randomized study to assess the tolerance and efficacy of intramuscular and subcutaneous administration of recombinant follicle-stimulating hormone (Puregon).
OBJECTIVE
To compare local tolerance and clinical efficacy after i.m. or s.c. injection of recombinant FSH (Puregon; NV Organon, Oss, The Netherlands).


METHODS
An open-label, prospective, randomized, group-comparative, multicenter study.


METHODS
Twelve IVF clinics in 10 countries.


METHODS
Two hundred eighteen infertile pituitary-suppressed women undergoing IVF-ET were randomized, of whom 195 (i.m., n = 77; s.c., n = 118) received recombinant FSH.


METHODS
One cycle of controlled ovarian hyperstimulation induced by either i.m. or s.c. injection of recombinant FSH, followed by IVF-ET.


METHODS
Local tolerance symptoms, number of oocytes retrieved, ongoing pregnancy rate.


RESULTS
The incidences after i.m. injection of bruising, pain, redness, swelling, and itching were 37.7%, 31.2%, 13.0%, 7.8%, and 6.5%; after s.c. injection, the corresponding figures were 54.2%, 28.0%, 16.1%, 5.9%, and 3.4%. Only bruising was significantly lower in the i.m. group, which could be attributed to the more visible superficial injection site with s.c. administration. The overall occurrence of local symptoms were 63.6% after i.m. injection and 68.6% after s.c. injection. The mean numbers of oocytes recovered were 9.8 (i.m) and 10.4 (s.c.) and the ongoing pregnancy rates per attempt were 27.1% (i.m.) and 26.1% (s.c.), respectively.


CONCLUSIONS
There were no marked differences in local tolerance symptoms and clinical efficacy between i.m. and s.c. administration of recombinant FSH.
Out
H J
HJ
Medical Research and Development Unit, NV Organon, Oss, The Netherlands.
Reimitz
P E
PE
Bennink
H J
HJ
D000328:Adult; D004624:Embryo Transfer; D004958:Estradiol / Q000097:blood; D005260:Female; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D011247:Pregnancy; D018873:Pregnancy Rate; D011446:Prospective Studies; D011994:Recombinant Proteins; D016896:Treatment Outcome
D011994:Recombinant Proteins; D004958:Estradiol; D005640:Follicle Stimulating Hormone