Comparison of two recombinant follicle-stimulating hormone preparations in in-vitro fertilization: a randomized clinical study.
A randomized comparison of two recombinant human follicle-stimulating hormone (recFSH) preparations (Gonal-F and Puregon) in ovarian stimulation for in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was carried out at the Infertility Clinic of the Family Federation of Finland. A total of 348 women (aged 22-43 years) suffering from infertility due to miscellaneous causes was recruited. Of these, 344 underwent stimulation using equal starting doses (150 IU/day: Gonal-F n = 164, Puregon n = 158 or 300 IU/day: Gonal-F n = 8, Puregon n = 14) after down-regulation with intranasal buserelin from the mid-luteal phase. Similar clinical pregnancy rates were achieved with both preparations; 33.5% per cycle and 37.4% per embryo transfer (24.5% one-embryo and 75.5% two-embryo transfers, n = 147) with Gonal-F (150 IU/day) and 32.9% per cycle and 36.4% per embryo transfer (30.1% one-embryo and 69.9% two-embryo transfers, n = 145) with Puregon (150 IU/day). The ongoing cumulative pregnancy rates after frozen-thawed embryo transfer were 35.4% with Gonal-F and 37.7% with Puregon. Six cycles were cancelled because of a low response (three in each group). Similar numbers of oocytes were obtained in both groups; 13.0 with 150 IU/day and 6.1 with 300 IU/day Gonal-F, and 12.4 with 150 IU/day and 7.1 with 300 IU/day Puregon. The fertilization and cleavage rates and the incidence of moderate or severe ovarian hyperstimulation syndrome (Gonal-F, 2.0% and Puregon, 0.7%) were also similar. Gonal-F and Puregon were equally and highly effective in stimulation for IVF and ICSI.
Tulppala
M
M
Infertility Clinic, The Family Federation of Finland, Kalevankatu 16, FIN-00100 Helsinki and Departments I and II of Obstetrics and Gynaecology, University Central Hospital of Helsinki, Helsinki, Finland.
Aho
M
M
Tuuri
T
T
Vilska
S
S
Foudila
T
T
Hakala-Ala-Pietilä
T
T
Moilanen
J
J
Bützow
T
T
Kaukoranta
S
S
Söderström-Anttila
V
V
Siegberg
R
R
Suikkari
A M
AM
Hovatta
O
O
D000328:Adult; D004624:Embryo Transfer; D005260:Female; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D043373:Follicle Stimulating Hormone, Human; D006801:Humans; D007246:Infertility / Q000628:therapy; D016471:Ovarian Hyperstimulation Syndrome / Q000209:etiology; D010062:Ovulation Induction; D011247:Pregnancy; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D020554:Sperm Injections, Intracytoplasmic
D043373:Follicle Stimulating Hormone, Human; D011994:Recombinant Proteins; D005640:Follicle Stimulating Hormone