Human Reproduction, Vol. 18, No. 6, 1194-1199,
June 2003
© 2003 European Society of Human Reproduction and Embryology
A prospective, randomized, controlled trial comparing highly purified hMG with recombinant FSH in women undergoing ICSI: ovarian response and clinical outcomes
1 Farah Hospital, Amman, Jordan and 2 Reproductive Endocrinology Center, University of Bologna, Via Massarenti 13 40138, Bologna, Italy
3 To whom correspondence should be addressed. e-mail: marco.filicori{at}unibo.it
BACKGROUND: To assess the clinical profile and efficacy in assisted reproductive treatment of a new human-derived highly purified (HP) menotropin, we compared HP hMG and recombinant (r) FSH
use in ICSI within a prospective, randomized, controlled study. METHODS: 100 infertile women were treated with HP hMG (50 patients) or rFSH (50 patients). All patients received the same daily gonadotrophin dose (150 IU) following GnRH agonist suppression (long regimen) until more than three follicles >17 mm and estradiol (E2) levels >600 pg/ml were reached. Patients were monitored with daily LH, FSH, hCG, estradiol (E2), progesterone, and testosterone measurements; and alternate day pelvic ultrasound. RESULTS: Treatment duration (11.1 ± 0.4 versus 12.9 ± 0.5 days, P < 0.05) and gonadotrophin dose (22.4 ± 1.0 versus 27.0 ± 1.5 ampoules, P < 0.05) were lower in the HP hMG group. Conversely, peak pre-ovulatory E2 (1342 ± 127 versus 933 ± 109 pg/ml, P < 0.005); and area under the curve of E2 (3491 ± 350 versus 2602 ± 349 pg/ml.day, P < 0.05), immunoreactive serum FSH (65.9 ± 2.1 versus 48.8 ± 1.8 IU/l.day, P < 0.001). and hCG (1.7 ± 0.3 versus 0.0 ± 0.0 IU/l/day, P < 0.001) during treatment were higher in the HP hMG group. Cycle cancellation rates, transferred embryo number, pregnancy rates per started cycle (30 versus 28%) and per embryo transfer (35 versus 35%) and miscarriage rates (6 versus 6%) were not significantly different. CONCLUSIONS: HP hMG treatment was associated with: (i) a more efficient patient response, as reflected by reduced treatment duration and gonadotrophin requirements; (ii) increased serum levels of hCG, E2, and immunoreactive FSH during treatment; (iii) an ICSI outcome indistinguishable from rFSH.
Key words: highly purified hMG/ICSI/LH/ovulation induction/recombinant FSH
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