Recombinant FSH Provides More Efficient, Cost-Effective Stimulation for Ovulation Induction/Intrauterine Insemination (OI/IUI) Cycles Than Highly Purified Urinary FSH.

Recombinant versus highly-purified, urinary follicle-stimulating hormone (r-FSH vs. HP-uFSH) in ovulation induction: a prospective, randomized study with cost-minimization analysis

“…Consistently with previously published reports [ 9 , 10 , 12 , 13 , 17 , 18 ] the results in terms of deliveries per started cycle and per ovulatory cycle were not significantly different with either r-FSH or HP-uFSH, although the delivery rate was slightly higher with the recombinant product. The cancellation of every cycle in which more than three preovulatory follicles were developed prevented our patients from experiencing twin pregnancies or ovarian hyperstimulation syndrome, that are unlikely when less than four follicles are developed.…”

“…Consistently to previous reports [ 9 - 12 , 14 , 17 , 18 ], the total FSH dose necessary to achieve ovulation was significantly lower using r-FSH. The reason for this can likely be found in the higher biological potency of r-FSH, in turn linked to the more basic spectrum of isoforms that gives more receptor binding affinity to the molecule, as well as to the lower proportion of degraded FSH forms in r-FSH [ 24 ].…”

“…Although r-FSH has been claimed to achieve some advantage in case of IVF treatment (more oocytes, more embryos available for transfer, a higher pregnancy chance with a lower total FSH dose and a shorter follicular phase) [ 2 , 4 , 7 , 8 , 22 , 23 ], only a few studies have been designed to compare r-FSH and uFSH in low-technology treatments, when monofollicular ovulation is preferable. Moreover, in most of these studies uFSH and not HP-uFSH was used [ 11 - 15 , 17 , 18 ], as only two of them compared rFSH to HP-uFSH in low-technology ART [ 9 , 10 ]. Furthermore, WHO group II anovulatory women were considered by some authors as an homogeneous group, without calculating the proportion of CC-resistant PCOS patients within the studied population [ 13 ].…”

“…The sample size calculation was performed using Graph-Pad StateMate version 2.0 (GraphPad Software, Inc. USA) as follows. Assuming from evidence of previous studies [ 9 - 12 , 14 , 17 , 18 ] a total amount of -20% ampules needed to reach ovulation in favour of r-FSH, the costs fixed by the Italian Health Service for 100 ampules of HP-uFSH and 80 ampules of r-FSH were calculated. This resulted in -17% cost in favour of HP-uFSH, assuming the effectiveness of both preparations to be the same.…”

“…On the other hand, only a few trials have compared r-FSH and uFSH in subfertile patients undergoing ovulation induction associated with intrauterine insemination (IUI) or timed sexual intercourse [ 9 - 14 ]. The limits of these studies are mainly two: a) some of them compared r-FSH to uFSH (and not to the more pure formulation HP-uFSH) [ 11 - 15 ], and b. some authors have considered as a group anovulatory, infertile women belonging to WHO group II without indicating the proportion of clomiphene citrate (CC)-resistant PCOS patients within the group [ 13 ].…”