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Follicle development is controlled amongst other factors by pituitary gonadotropins follicle-stimulating hormone (FSH) and luteinizing hormone (LH) that act in synergy in completing follicle maturation. Exogenous gonadotropins, combined with gonadotropin-releasing hormone agonists, have been successfully used in patients with ovulatory disorders undergoing assisted reproduction. There is some evidence of a beneficial role of androgens or LH administration before FSH stimulation. This study was designed to verify whether the addition of LH in the early follicular phase, in downregulated patients undergoing follicular stimulation for assisted reproduction, would add benefits in terms of general outcomes and pregnancy rates. We compared two groups of patients one of which was treated with recombinant FSH (rFSH) alone and the other with rFSH plus recombinant LH (rLH), in the early follicular phase only. The number of eggs recovered was higher in the group treated with FSH only; however, the number of embryos available at transfer was similar in the two groups and, more importantly, the number of Grades I and II embryos was higher in the group pretreated with LH. Similarly, although biochemical pregnancy rate and clinical pregnancy rates were similar in both groups, a beneficial role of LH priming was demonstrated by the higher implantation rate achieved in these patients. [ABSTRACT FROM AUTHOR]

Aim. To compare the clinical pregnancy rate in recipients of oocytes from donors treated with leuprorelin + human menopausal gonadotropins (hMG) with that obtained when the donors were treated with ganirelix + recombinant follicle-stimulating hormone (rFSH). The secondary aim was to compare the donors' response to the two treatments. Method. A prospective, randomized, comparative study was conducted between January 2005 and November 2006 in a private hospital. Donors were randomized to receive a long protocol of leuprorelin + hMG (group DI) or ganirelix + rFSH (group DII). Their respective recipients were randomized to group RI or group RII, respectively. Results. The characteristics of the donors were similar in both groups. More cycles were cancelled in group DI than in group DII (28.1% vs. 2.5%; p < 0.05). Compared with donors in group DII, the donors in group DI required a significantly higher dose of gonadotropins (2794 ± 957 U vs. 1777 ± 1043 U; p < 0.05) and more days of stimulation (11.7 ± 2.3 vs. 9.5 ± 1.5; p < 0.05); they also yielded fewer oocytes (15.0 ± 6.1 vs. 17.9 ± 8.6; p < 0.05). There were no differences in the characteristics of the recipients, in the fertilization rate or in the number of embryos transferred. The quality of transferred embryos was better in group RI (8.0 ± 1.2 vs. 7.5 ± 1.6; p < 0.05), and this group also achieved a better pregnancy rate per embryo transfer than did group RII (62.3% vs. 48.4%; p < 0.05). Conclusions. Treating oocyte donors with leuprorelin + hMG produces among recipients a greater probability of clinical pregnancy per embryo transfer than when donors are treated with ganirelix + rFSH; however, more cycles are cancelled and the former treatment is more unpleasant for donors. [ABSTRACT FROM AUTHOR]

Objective. Recently we proposed a randomized trial specifically designed to evaluate the cost-effectiveness of two different protocols of stimulation in intrauterine insemination (IUI) cycles. Computer-simulated clinical models have been developed to perform pharmacoeconomic studies, creating a decision tree in which the complex procedure is performed and repeated. The present study was designed to compare the cost-effectiveness of recombinant follicle-stimulating hormone (rFSH) and human-derived FSH (hFSH) in ovarian stimulation and to indicate which protocol should be used in IUI cycles. Study design. Two computer-generated decision tree models were constructed to compare the clinical effects and costs of rFSH versus hFSH in IUI cycles. A first decision tree model was built according to the trial previously published. In a second model, 10 000 hypothetical infertile patients were entered in a computer-generated simulation and were stimulated with two different protocols for IUI. IUI was hypothetically performed in both groups of patients with a known pregnancy, cancellation, miscarriage and abandonment rate. The two protocols were compared using a cost-effective analysis: cost-effectiveness ratios (CE) and incremental cost-effectiveness ratios (ICER) were calculated. The cost-effectiveness acceptability curve (CEAC) was constructed. Results. The overall estimated costs with each ovarian stimulation strategy in the first model demonstrated that rFSH was a less cost-effective strategy, with an ICER of [euro]13 727. The CEAC showed that at a level of [euro]0 of willingness to pay, hFSH was cost-effective in 73% of the samples while rFSH was cost-effective in 27% only. Recombinant FSH would be more cost-effective than hFSH at an effectiveness threshold of 0.170 and at a cost per cycle of [euro]235. This finding was also confirmed by the acceptability curve obtained with 10 000 Monte Carlo simulations, in which hFSH was cost-effective in about 96-98% of samples at any threshold of willingness to pay. Conclusions. This study represents the first statistical model developed with a computer-generated clinical simulation with the intent to elaborate a pharmacoeconomic comparison between rFSH and hFSH in ovarian stimulation for IUI cycles. Results demonstrated that hFSH is more cost-effective than rFSH. [ABSTRACT FROM AUTHOR]

The renewed interest in luteinizing hormone (LH), together with limited and decreasing health resources, make essential the comparison of high-cost, recombinant follicle-stimulating hormone (rFSH) preparations (devoid of LH) and human menopausal gonadotropin (hMG) in terms of clinical efficacy. All published, randomized controlled trials (RCTs) comparing rFSH versus hMG under different protocols of stimulation were examined. Eight true RCTs were included in this meta-analysis, recruiting 2031 participants. Data for ongoing pregnancy/live birth rate, clinical pregnancy rate, miscarriage rate, multiple pregnancy rate and ovarian hyperstimulation syndrome (OHSS) were extracted, and odds ratios (ORs) and 95% confidence intervals (CIs) were calculated with the use of a fixed-effects model. Data for the meta-analysis were combined using RevMan software (using the Mantel–Haenszel method). Pooling the results of these RCTs showed no significant difference between rFSH and hMG regarding the different outcomes: ongoing pregnancy/live birth rate, OR 1.18 (95% CI 0.93–1.50); clinical pregnancy rate, OR 1.2 (95% CI 0.99–1.47), miscarriage rate, OR 1.2 (95% CI 0.70–2.16); multiple pregnancy rate, OR 1.35 (95% CI 0.96–1.90); incidence of moderate/severe OHSS, OR 1.79 (95% CI 0.74–4.33). However, there was significant reduction in the amount of gonadotropins in favor of hMG over rFSH. There was no significant heterogeneity of treatment effect across the trials. In conclusion, there is no clinically significant difference between hMG and rFSH in in vitro fertilization/intracytoplasmic sperm injection cycles. Decision-makers should establish their choice of one drug over the other based on the most up-to-date evidence available. [ABSTRACT FROM AUTHOR]