Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation.
OBJECTIVE
To assess the efficacy, safety, and local tolerance of ganirelix acetate for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH).


METHODS
Phase III, multicenter, open-label randomized trial.


METHODS
In vitro fertilization (IVF) centers in North America.


METHODS
Healthy female partners (n = 313) in subfertile couples for whom COH and IVF or intracytoplasmic sperm injection were indicated.


METHODS
Patients were randomized to receive one COH cycle with ganirelix or the reference treatment, a long protocol of leuprolide acetate in conjunction with follitropin-beta for injection.


METHODS
Number of oocytes retrieved, pregnancy rates, endocrine variables, and safety variables.


RESULTS
The mean number of oocytes retrieved per attempt was 11.6 in the ganirelix group and 14.1 in the leuprolide group. Fertilization rates were 62.4% and 61.9% in the ganirelix and leuprolide groups, respectively, and implantation rates were 21.1% and 26.1%. Clinical and ongoing pregnancy rates per attempt were 35.4% and 30.8% in the ganirelix group and 38.4% and 36.4% in the leuprolide acetate group. Fewer moderate and severe injection site reactions were reported with ganirelix (11.9% and 0.6%) than with leuprolide (24.4% and 1.1%).


CONCLUSIONS
Ganirelix is effective, safe, and well tolerated. Compared with leuprolide acetate, ganirelix therapy has a shorter duration and fewer injections but produces a similar pregnancy rate.
Fluker
M
M
Genesis Fertility Center, Vancouver, British Columbia, Canada.
Grifo
J
J
Leader
A
A
Levy
M
M
Meldrum
D
D
Muasher
S J
SJ
Rinehart
J
J
Rosenwaks
Z
Z
Scott
R T
RT
Schoolcraft
W
W
Shapiro
D B
DB
D000328:Adult; D006063:Chorionic Gonadotropin / Q000097:blood; D004311:Double-Blind Method; D004622:Embryo, Mammalian / Q000187:drug effects; D005260:Female; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage / Q000494:pharmacology; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology*; D006727:Hormone Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D010053:Ovary / Q000187:drug effects*; D011247:Pregnancy; D011374:Progesterone / Q000097:blood; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D013268:Stimulation, Chemical
D006063:Chorionic Gonadotropin; D006727:Hormone Antagonists; D011994:Recombinant Proteins; D007987:Gonadotropin-Releasing Hormone; D011374:Progesterone; D005640:Follicle Stimulating Hormone; D016729:Leuprolide; C061018:ganirelix