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Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer.

ABSTRACT: To compare the ovarian responses after administration of two recombinant follicle-stimulating hormone (r-FSH) preparations under gonadotropin-releasing hormone (GnRH) analogue downregulation, we conducted a phase 3, randomized, multicenter, assessor-blind, active-controlled, parallel group study. The primary outcome was the number of oocytes retrieved. The secondary outcomes included total dose and duration of r-FSH administered, oocyte quality, blood estradiol levels, follicular development, fertilization rates, implantation rates, and pregnancy rates (biochemical, clinical, and ongoing). A total of 451 patients with infertility were randomized to receive either Follitrope™ Prefilled Syringe or Gonal-F^® Pen for ovarian stimulation. The mean number of oocytes retrieved was 14.9 in the Follitrope^TM Prefilled Syringe group, and 12.8 in the Gonal-F^® Pen group. The 95% confidence interval in the oocyte number difference between the groups was [-0.1, 4.2], demonstrating that Follitrope^TM Prefilled Syringe was not inferior to Gonal-F^® Pen. The clinical pregnancy rates (Follitrope^TM Prefilled Syringe vs. Gonal-F^® Pen: 55.4% vs. 51.9%) and ongoing pregnancy rates (44.1% vs. 43.0%) were similar between the groups. No clinically significant adverse events were observed in either group. In summary, our study indicates that Follitrope^TM Prefilled Syringe is safe and efficacious for ovarian stimulation.

SUBMITTER: Hu L

PROVIDER: S-EPMC7138541 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing <i>in vitro</i> fertilization-embryo transfer.

Hu Linli L Zhang Songying S Quan Song S Lv Jieqiang J Qian Weiping W Huang Yuanhua Y Lu Weiying W Sun Yingpu Y

Aging 20200325 6

To compare the ovarian responses after administration of two recombinant follicle-stimulating hormone (r-FSH) preparations under gonadotropin-releasing hormone (GnRH) analogue downregulation, we conducted a phase 3, randomized, multicenter, assessor-blind, active-controlled, parallel group study. The primary outcome was the number of oocytes retrieved. The secondary outcomes included total dose and duration of r-FSH administered, oocyte quality, blood estradiol levels, follicular development, fe ...[more]

PMID: 32209728

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Project description:Background: Currently, more and more subfertility couples are opting for combined acupuncture to improve the success rate of in vitro fertilization and embryo transfer (IVF-ET). However, the efficacy and safety of acupuncture in IVF-ET is still highly controversial. Objectives: The purpose of this overview is to summarize evidence of essential outcomes of systematic reviews (SRs) of acupuncture in IVF-ET and evaluate their methodological quality. Methods: We conducted a comprehensive literature search for relevant SRs in eight databases from inception to July 31, 2020, without language restriction. We evaluated the methodological quality of the included SRs by using A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR-2), which was the latest available assessment tool. The Risk of Bias in Systematic Review (ROBIS) tool was used to assess the risk of bias in SRs. We assessed the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) score to determine the strength of evidence. We excluded the overlapping randomized controlled trials (RCTs) and performed a re-meta-analysis of the primary RCTs. Results: This review included 312 original RCT studies and 65,388 participants. By using AMSTAR-2, we found that the methodological quality of 16 SRs was critically low, because they had more than one critical weakness. Our reviews showed that although the GRADE for quality of evidence profile was suboptimal, acupuncture seemed to be beneficial in increasing the pregnancy rate. Our re-meta-analysis suggested that acupuncture was superior to sham acupuncture in improving the clinical pregnancy rate (CPR) of IVF-ET with substantial heterogeneity (RR = 1.31, 95% CI: 1.13-1.52, p = 0.0004, I 2 = 66%). No statistical difference was observed regarding the outcomes of live birth rate (LBR), ongoing pregnancy rate (OPR), biochemical pregnancy rate (BPR), and miscarriage rate (MR) between two groups. When compared with no adjunctive treatment groups, acupuncture improved CPR (RR = 1. 25, 95% CI: 1.11-1.42, p = 0.0003) and OPR (RR = 1. 38, 95% CI: 1.04-1.83, p = 0.03). Acupuncture was more superior than no adjunctive treatment in reducing MR (OR = 1.42, 95% CI: 1.03-1.95, p = 0.03) and BPR (RR = 1.19, 95% CI: 1.02-1.37, p = 0.02). Conclusions: Although the evidence of acupuncture in IVF-ET is insufficient, acupuncture appears to be beneficial to increase the clinical pregnancy rate in women undergoing IVF-ET. However, there are severe heterogeneity and methodological quality defects, which limit the reliability of results. Further, high-quality primary studies are still needed.

Dataset Information

Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer.

Publications

Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing <i>in vitro</i> fertilization-embryo transfer.

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