Human Reproduction, Vol 12, 2133-2139, Copyright © 1997 by Oxford University Press
C Bergh, CM Howles, K Borg, L Hamberger, B Josefsson, L Nilsson and M Wikland
A prospective, randomized, comparative, assessor-blind study was carried
out in two centres to compare the efficacy and safety of recombinant human
follicle stimulating hormone (r-hFSH; Gonal-F) versus highly purified
urinary FSH (u-hFSH HP; Metrodin HP), both administered s.c. in women
undergoing ovarian stimulation for in-vitro fertilization including
intracytoplasmic sperm injection (ICSI). A total of 235 patients started a
long gonadotrophin-releasing hormone agonist protocol: 119 received r-hFSH
and 114 received u-hFSH HP (150 IU/day) for the first 6 days. Two patients
were excluded from the study because they mistakenly received the incorrect
treatment combination. Human chorionic gonadotrophin (HCG; 10000 IU, s.c.)
was administered once there was at least one follicle 18 mm in diameter and
two others > or = 16 mm. In all, 119 (100%) and 102 (89%) of the
patients respectively in the r-hFSH and u-hFSH HP groups achieved the
criteria for HCG. The mean numbers (+/- SD) of oocytes recovered (the
primary endpoint) were 12.2 +/- 5.5 and 7.6 +/- 4.4 in the r-hFSH and
u-hFSH HP groups respectively (P < 0.0001). However, the number of FSH
treatment days (11.0 +/- 1.6 versus 13.5 +/- 3.7) and the number of 75 IU
ampoules (21.9 +/- 5.1 versus 31.9 +/- 13.4) used were significantly less
(P < 0.0001) in the r-hFSH group than in the u-hFSH HP group. In
patients treated using ICSI (63 patients in each group), no difference in
oocyte maturation was observed. The mean numbers of embryos obtained were
8.1 +/- 4.2 and 4.7 +/- 3.5 (P < 0.0001), in favour of the r-hFSH group.
In the majority of patients (96 and 99% respectively) only one or two
embryos were replaced (mean 2.0 +/- 0.2 and 1.9 +/- 0.1 respectively) in
the r- hFSH and u-hFSH HP groups. The clinical pregnancy rates per started
cycle and per embryo transfer were 45 and 36%, and 48 and 47%, respectively
in the r-hFSH and u-hFSH HP groups (not significant). There were six (5.1%)
and two (1.7%) cases of ovarian hyperstimulation syndrome respectively. In
conclusion, it was found that r-hFSH was more effective than u-hFSH at
inducing multiple follicular development. However, the high rate of low
ovarian response in the u-hFSH group compared with our general experience
was unexpected. The availability of a gonadotrophin with less inter-batch
variation would be beneficial for clinicians. r-hFSH seems to fulfil such a
requirement.
ARTICLES
Recombinant human follicle stimulating hormone (r-hFSH; Gonal-F) versus highly purified urinary FSH (Metrodin HP): results of a randomized comparative study in women undergoing assisted reproductive techniques
Department of Obstetrics and Gynaecology, Sahlgrenska Hospital, University of Goteborg, Sweden.
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