Clinical outcomes following long GnRHa ovarian stimulation with highly purified human menopausal gonadotropin plus rFSH or rFSH in patients undergoing in vitro fertilization-embryo transfer: a multi-center randomized controlled trial.

BACKGROUND: This clinical trial aimed to compare the clinical efficacy of highly purified human menopausal gonadotropin (HP-HMG) plus recombinant human follicle-stimulating hormone (rFSH) versus rFSH alone on controlled ovarian stimulation (COS) in vitro fertilization-embryo transfer (IVF-ET). METHODS: A total of 610 women underwent long gonadotropin-releasing hormone (GnRH) agonist protocol for IVF treatment. The subjects were randomized into 2 groups: HP-HMG + rFSH group (n=305) and rFSH group (n=305). The main outcome was the progesterone (P) level on the day of HCG injection. RESULTS: There was no significant difference in terms of the demographic and baseline characters between the two groups. In rFSH group, the P level on the day of HCG trigger were significantly higher than that of HP-HMG+rFSH group (4.3±2.2 vs. 3.8±1.7 nmol/L, P<0.001). The fertilization rate in rFSH group was significantly lower than that of HP-HMG + rFSH group (69.2% vs. 73.9%, P<0.001). Simultaneously, the percentage of cycles with fresh embryo transfer in rFSH group was also significantly lower than that of HP-HMG + rFSH group (49.6% vs. 57.5%, P=0.007). However, there was no difference in terms of cleavage rate, implantation rate, clinical pregnancy rate and ovarian hyperstimulation syndrome (OHSS) rate between two groups. CONCLUSIONS: The use of combined HP-HMG with FSH may be superior to rFSH alone in stimulating the ovary in normal responders undergoing IVF treatment. Furthermore, the further prospective studies with large sample are still needed to confirm the study.

The Efficacy of Recombinant Human Follicle Stimulating Hormone (rhFSH) in Human IVF-ET Program / 대한불임학회지

OBJECTIVES: Recently, recombinant FSH (rFSH) has been manufactured using a Chinese hamster ovary cell line transfected with the gene encoding human FSH. Both rFSH and urinary gonadotropin (uFSH) could be used for controlled ovarian hyperstimulation (COH). However, uFSH implies a number of disadvantages, such as batch-to-batch inconsistency, no absolute source control, dependence on large amounts of urine, low specific activity, and low purity. The purpose of this study was to evaluate the efficacy of rFSH in human IVF-ET program. MATERIALS AND METHODS: A total of 508 infertile women was enrolled in this study. They are classified into rFSH group (n=177) or uFSH group (n=331), and all of them were matched by age and cause of infertility in same period. The Puregon(R) (Organon, Holland) was used as rFSH, and the Metrodin-HP(R) (Serono, Switzeland) and Humegon(R) (Organon, Holland) was used as uFSH. We subdivided the patients into three age groups. The outcomes of IVF-ET program were analyzed using the statistical package for social sciences (SPSS). RESULTS: There was no significant differences in the level of estradiol on hCG injection day, the numbers of retrieved oocytes, matured oocytes, fertilized oocytes, transferred embryos, frozen embryos between the two groups. The total dose (IU) of gonadotropin for COH was significantly lower in the rFSH group compared to uFSH group (1339+/-5491.1 vs 2527.8+/-1075.2 IU, p<0.001). Clinical pregnancy rate per embryo transfer in the rFSH group showed increasing tendency, compared to the uFSH group, but there was no statistical significance (35.2% vs 29.3%). Our results demonstrated that the relative efficiency of rFSH compared with uFSH is higher in older patients. CONCLUSIONS: The ovarian stimulatory effect and clinical outcome of recombinant FSH was similar to that of the urinary gonadotropin. The IVF-ET cycles with significantly lower dose of gonadotropin in rFSH group showed comparable results. Therefore, we suggest that recombinant FSH is more potent and effective than urinary gonadotropin.

Recombinant Human Follicle Stimulating Hormone (rFSH) versus Highly Purified Urinary FSH (uFSH): Oocyte and Embryo Quality / 대한산부인과학회잡지

OBJECTIVE: To estimate the efficacy of recombinant human follicle stimulating hormone (rFSH) versus highly purified urinary human FSH (uFSH) in women undergoing controlled ovarian hyperstimulation (COH) for in vitro fertilization and embryo transfer (IVF-ET). METHODS: From 1 January 2001 to 31 August 2001, A total of 254 cycles from 241 patients who attended infertility clinic at Samsung cheil hospital was enrolled in this study. With pituitary down regulation using GnRH agonist by short protocol, rFSH (Puregon(R), Organon, Netherlands) was administered in 131 cycles and uFSH (Metrodin-HP(R), Serono, Switzerland) was administered in 123 cycles. We analyzed ovarian response, pregnancy rate, live birth rate, oocyte quality and embryo quality. RESULTS: The clinical characteristics of two groups were not different. Total FSH dosages (1322.3+/-526.2 IU versus 2124.4+/-881.9 IU, p<0.001) and dosages per retrieved oocyte (90.6+/-36.0 IU versus 138.0+/-57.2 IU, p<0.001) were significantly lower in rFSH group than uFSH group. Clinical pregnancy rate and live birth rate of two groups were not significantly different. The rate of good quality oocyte (Grade I and II) from retrieved oocytes was higher in rFSH group (68.2% versus 64.8%, p=0.024), but after preincubating oocytes for 4 to 6 hours and removing cumulus cells in intracytoplasmic sperm injection (ICSI) cycles, nuclear maturity of oocytes were not significantly different. The quality of transferred embryos were not significantly different too. CONCLUSION: rFSH offered more effective ovarian response in COH and better quality of retrieved oocytes, compared with uFSH.