Effectiveness of highly purified human menopausal gonadotropin vs. recombinant follicle-stimulating hormone in first-cycle in vitro fertilization–intracytoplasmic sperm injection patients
Received 15 March 2007; received in revised form 23 May 2007; accepted 23 May 2007. published online 07 August 2007.
Objective
To compare the effectiveness of highly purified hMG with recombinant FSH (rFSH) in IVF–intracytoplasmic sperm injection patients who were treated with a GnRH agonist.
Design
An open-label, prospective, randomized comparison of fixed gonadotropin regimens.
Setting
Eighteen Dutch IVF centers.
Patient(s)
Six hundred twenty-nine patients who were selected for IVF–intracytoplasmic sperm injection.
Intervention(s)
Patients were randomized to receive either highly purified hMG or rFSH in a fixed dosage of 150 IU/d after GnRH-agonist suppression (long protocol).
Main Outcome Measure(s)
Ongoing pregnancy rate per started cycle. Difference between the two treatment groups was tested by using odds ratios, including the 95% confidence limits (intention-to-treat sample), and by using the Fisher's exact test (per-protocol sample).
Result(s)
The ongoing pregnancy rates per started cycle were 26.3% and 25.2% for highly purified hMG and rFSH, respectively (no statistically significant difference). Treatment with highly purified hMG resulted in statistically significantly fewer oocytes (n = 7.8) than did treatment with rFSH (n = 10.6). There were no differences with respect to fertilization rates and implantation rates. Cycles with highly purified hMG were statistically significantly less often canceled as a result of ovarian hyperresponse (2.0% vs. 6.0% for highly purified hMG and rFSH, respectively).
Conclusion(s)
Compared with rFSH, highly purified hMG did not result in superiority in ongoing pregnancy rates in first-cycle IVF–intracytoplasmic sperm injection patients who were treated with a fixed dosage of 150 IU of gonadotropin per day. Compared with rFSH, treatment with highly purified hMG resulted in retrieval of fewer oocytes, a lower incidence of hyperresponse, and comparable pregnancy rates.
aVrije Universiteit Medical Centre, Amsterdam, The Netherlands
bUniversity Medical Centre Utrecht, Utrecht, The Netherlands
Reprint requests: Peter G. A. Hompes, M.D., Ph.D., Department of Obstetrics and Gynaecology, Vrije Universiteit Medical Centre, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands (FAX: 31-20-444-00-45).
The research institutes of the participating centers were supported by Ferring BV, Hoofddorp, The Netherlands. P.G.A.H. has conducted clinical research sponsored by Abbott, Ferring, Organon, Schering, and Serono. F.J.B. has conducted clinical research sponsored by Wyeth, Ferring, Organon, and Serono.
† FIRM = First IVF-ICSI Cycle Recombinant FSH vs. Menotropin.
ABSTRACT