Recombinant human chorionic gonadotropin (rhCG) in assisted reproductive technology: results of a clinical trial comparing two doses of rhCG (Ovidrel) to urinary hCG (Profasi) for induction of final follicular maturation in in vitro fertilization-embryo transfer.
OBJECTIVE
To compare the efficacy and safety of 250 microg and 500 microg of recombinant hCG with 10,000 U USP of urinary hCG in assisted reproduction technology.


METHODS
Open, comparative, randomized, prospective clinical study.


METHODS
Twenty tertiary care U.S. infertility centers.


METHODS
Two hundred ninety-seven ovulatory infertile women undergoing a single cycle of assisted reproduction technology.


METHODS
Patients were randomized 1:1:1 to 250 microg of recombinant hCG SC, 500 microg of recombinant hCG SC, or 10,000 U USP urinary hCG IM after completing gonadotropin stimulation.


METHODS
Number of oocytes retrieved per patient receiving hCG. Also, measures of oocyte maturity, embryo development, and luteal function, as well as pregnancy and pregnancy outcome. Adverse safety events, laboratory changes, local tolerance, and immunogenicity were also assessed.


RESULTS
Mean numbers of oocytes retrieved per treatment group were equivalent, 13.6, 14.6, and 13.7 with 250 microg of recombinant hCG, 500 microg of recombinant hCG, and urinary hCG, respectively. The numbers of 2PN fertilized oocytes on day 1 after oocyte retrieval, and 2PN or cleaved embryos on the day of embryo transfer, were significantly higher with 500 microg of recombinant hCG than with the lower dose. However, the incidence of adverse events also tended to be higher with this dose.


CONCLUSIONS
Recombinant hCG is effective and well tolerated in the induction of final follicular maturation and luteinization in women undergoing assisted reproduction technology. Recombinant hCG (250 microg) SC is equivalent to 10,000 U USP of urinary hCG in this indication.
Chang
P
P
Clinical Development, Serono, Inc., Norwell, Massachusetts, USA.
Kenley
S
S
Burns
T
T
Denton
G
G
Currie
K
K
DeVane
G
G
O'Dea
L
L
D000328:Adult; D006063:Chorionic Gonadotropin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D002970:Cleavage Stage, Ovum; D004305:Dose-Response Relationship, Drug; D004624:Embryo Transfer; D005260:Female; D005306:Fertilization; D005307:Fertilization in Vitro; D006801:Humans; D007247:Infertility, Female / Q000628:therapy; D009865:Oocytes / Q000502:physiology; D006080:Ovarian Follicle / Q000187:drug effects* / Q000502:physiology*; D011446:Prospective Studies; D011994:Recombinant Proteins; D012099:Reproductive Techniques; D020858:Tissue and Organ Harvesting; D016896:Treatment Outcome
D006063:Chorionic Gonadotropin; C412828:Ovidrel; C412829:Profasi; D011994:Recombinant Proteins