A comparison of the efficacy and tolerability of two recombinant human follicle-stimulating hormone preparations in patients undergoing in vitro fertilization-embryo transfer.
OBJECTIVE
To compare the efficacy and tolerability of two recombinant human FSH (r-hFSH) preparations, follitropin-alpha (Gonal-F; Ares Serono, Geneva, Switzerland) and follitropin-beta (Puregon; Organon, Oss, the Netherlands), for superovulation in patients undergoing IVF-ET.


METHODS
Randomized, parallel-group, assessor-blind, single-center trial.


METHODS
Outpatient tertiary referral center for assisted reproductive techniques.


METHODS
Forty-four infertile women undergoing IVF-ET.


METHODS
After down-regulation with buserelin acetate, patients were randomized to receive follitropin-alpha or follitropin-beta, 150 IU/d for 6 days; after that, dosages were adjusted according to the ovarian response.


METHODS
Cumulative dose of r-hFSH; duration of r-hFSH treatment; number of follicles of > or =11 mm and of 14 mm on day 7 of r-hFSH treatment and on the day of hCG administration; number of oocytes retrieved; number of viable embryos; and number of pregnancies (biochemical, ectopic, miscarried) and clinical pregnancies.


RESULTS
There were no statistically significant differences in any efficacy measures between the two preparations. The incidence of systemic adverse events was comparable in the two groups. Local reactions at the injection site were significantly more common and more severe with follitropin-beta than with follitropin-alpha


CONCLUSIONS
Follitropin-alpha and follitropin-beta have comparable efficacy in patients undergoing IVF-ET.
Brinsden
P
P
Bourn Hall Clinic, Cambridge, United Kingdom.
Akagbosu
F
F
Gibbons
L M
LM
Lancaster
S
S
Gourdon
D
D
Engrand
P
P
Loumaye
E
E
D000293:Adolescent; D000328:Adult; D002064:Buserelin / Q000627:therapeutic use; D006063:Chorionic Gonadotropin / Q000008:administration & dosage; D004624:Embryo Transfer; D005260:Female; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage / Q000627:therapeutic use*; D037201:Follicle Stimulating Hormone, beta Subunit; D015292:Glycoprotein Hormones, alpha Subunit / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007247:Infertility, Female / Q000628:therapy; D011247:Pregnancy; D011994:Recombinant Proteins / Q000627:therapeutic use
D006063:Chorionic Gonadotropin; D037201:Follicle Stimulating Hormone, beta Subunit; D015292:Glycoprotein Hormones, alpha Subunit; D011994:Recombinant Proteins; D005640:Follicle Stimulating Hormone; D002064:Buserelin