A group-comparative, randomized, double-blind comparison of the efficacy and efficiency of two fixed daily dose regimens (100- and 200-IU) of recombinant follicle stimulating hormone (rFSH, Puregon) in Asian women undergoing ovarian stimulation for IVF/ICSI.
OBJECTIVE
To compare the efficacy, efficacy and safety of a fixed daily dose of recombinant FSH (Puregon) of a 100- and 200-IU regimen in Asian women undergoing ovarian stimulation for IVF/ICSI.


METHODS
This was a prospective, randomized, double-blind, multicenter (n = 9) study. Prior to the start of rFSH, all women were pretreated with a gonadotropin releasing hormone agonist (GnRH-a) for pituitary downregulation.


RESULTS
A total of 330 women were treated with rFSH: 163 subjects with 100 IU and 167 subjects with 200 IU. In the 200 IU treatment group, significantly more oocytes were retrieved compared to the 100 IU group (9.6 vs. 5.0 oocytes, p < 0.001). The total dose rFSH needed to develop at least three follicles with a diameter of >17 mm was significantly lower in the 100 IU treatment group (1,194 vs. 2,034 IU, p < 0.001). Although more cycle cancellations were seen in the 100 IU group (24 vs. 13%), the ongoing pregnancy rate per started cycle was comparable between both groups (16.6% in the 100 IU group vs. 15.0% in the 200 IU group).


CONCLUSIONS
The use of a 100 IU fixed dose is less effective in terms of the number of oocytes retrieved and the higher cancellation rate, but more efficient as indicated by a lower total recombinant FSH dose needed.
Hoomans
Eric H M
EH
Organon Nederland bv, Oss, The Netherlands. e.hoomans@organon.nl
Mulder
Bernard B
BB
D000328:Adult; D001208:Asia; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005300:Fertility Agents, Female / Q000627:therapeutic use; D005307:Fertilization in Vitro / Q000379:methods; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D043373:Follicle Stimulating Hormone, Human; D006801:Humans; D010060:Ovulation / Q000187:drug effects* / Q000502:physiology; D010062:Ovulation Induction; D011247:Pregnancy; D018873:Pregnancy Rate; D011374:Progesterone / Q000097:blood; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
D005300:Fertility Agents, Female; D043373:Follicle Stimulating Hormone, Human; D011994:Recombinant Proteins; D011374:Progesterone; D005640:Follicle Stimulating Hormone