Abstract
BackgroundBoth recombinant FSH (r-FSH) and highly-purified, urinary FSH (HP-uFSH) are frequently used in ovulation induction associated with timed sexual intercourse. Their effectiveness is reported to be similar, and therefore the costs of treatment represent a major issue to be considered. Although several studies about costs in IVF have been published, data obtained in low-technology infertility treatments are still scarce.MethodsTwo hundred and sixty infertile women (184 with unexplained infertility, 76 with CC-resistant polycystic ovary syndrome) at their first treatment cycle were randomized and included in the study. Ovulation induction was accomplished by daily administration of rFSH or HP-uFSH according to a low-dose, step-up regimen aimed to obtain a monofollicular ovulation. A bi- or tri-follicular ovulation was anyway accepted, whereas hCG was withdrawn and the cycle cancelled when more than three follicles greater than or equal to 18 mm diameter were seen at ultrasound. The primary outcome measure was the cost of therapy per delivered baby, estimated according to a cost-minimization analysis. Secondary outcomes were the following: monofollicular ovulation rate, total FSH dose, cycle cancellation rate, length of the follicular phase, number of developing follicles (>12 mm diameter), endometrial thickness at hCG, incidence of twinning and ovarian hyperstimulation syndrome, delivery rate.ResultsThe overall FSH dose needed to achieve ovulation was significantly lower with r-FSH, whereas all the other studied variables did not significantly differ with either treatments. However, a trend toward a higher delivery rate with r-FSH was observed in the whole group and also when results were considered subgrouping patients according to the indication to treatment.ConclusionConsidering the significantly lower number of vials/patient and the slight (although non-significant) increase in the delivery rate with r-FSH, the cost-minimization analysis showed a 9.4% reduction in the overall therapy cost per born baby in favor of r-FSH.
Highlights
In the last decades, follicle-stimulating hormone (FSH) has assumed a central role in ovulation induction and has been shown to be highly effective in achieving ovulation in anovulatory infertile woman as well as in ovulation induction protocols for subfertile, ovulatory women and in superovulation for IVF [1]
Recombinant FSH (r-FSH) and urinary FSH (u-FSH) have been repeatedly compared in trials dealing with superovulation induction for IVF
The limits of these studies are mainly two: a) some of them compared recombinant FSH (r-FSH) to uFSH [11,12,13,14,15], 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 polycystic ovary syndrome (PCOS) patients within the group [13]
Summary
Follicle-stimulating hormone (FSH) has assumed a central role in ovulation induction and has been shown to be highly effective in achieving ovulation in anovulatory infertile woman as well as in ovulation induction protocols for subfertile, ovulatory women and in superovulation for IVF [1]. 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 [9,10,11,12,13,14]. The above mentioned clinical trials have not allowed to draw definite conclusions about the relative effectiveness of r-FSH and u-FSH (or HP-uFSH) in patients undergoing low-technology assisted reproduction therapies [16], indicating the need for further studies. Both recombinant FSH (r-FSH) and highly-purified, urinary FSH (HP-uFSH) are frequently used in ovulation induction associated with timed sexual intercourse. Several studies about costs in IVF have been published, data obtained in lowtechnology infertility treatments are still scarce
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