ORCID Profile
0000-0002-3934-2302
Current Organisation
University of Adelaide
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Publisher: Springer Science and Business Media LLC
Date: 02-04-2021
DOI: 10.1186/S12958-021-00727-Y
Abstract: Live birth has increasingly been identified as the standard clinical approach to measure the success of medically assisted reproduction (MAR). However, previous analyses comparing biosimilar preparations of follitropin alfa versus the reference product (GONAL-f®, Merck KGaA, Darmstadt, Germany or GONAL-f® RFF EMD Serono, Inc., Rockland, MA), have had insufficient power to detect differences in clinically meaningful outcomes such as live birth. Medline, Embase, the Cochrane Library, Web of Science and clinical trial registries were searched for randomised controlled trials (RCTs) and conference abstracts comparing biosimilar follitropin alfa versus the reference product in controlled ovarian stimulation (COS) cycles published before 31 October 2020. Only studies in humans and publications in English were included. Retrieved studies were screened independently by two authors based on titles and abstracts, and then by full text. Inclusion criteria: RCTs comparing follitropin alfa biosimilar preparations with the reference product in infertile patients of any age, with any type of infertility for any duration, undergoing COS for the purposes of MAR treatment (including frozen cycles). The primary outcome was live birth. Combined data for biosimilar preparations were analysed using a fixed-effects model. From 292 unique records identified, 17 studies were included in the systematic review, representing five unique RCTs that were included in the meta-analysis. Rates of live birth (RR = 0.83, 95% CI 0.71, 0.97 4 RCTs, n = 1881, I 2 = 0%), clinical pregnancy (RR = 0.82, 95% CI 0.72, 0.94 4 RCTs, n = 2222, I 2 = 0%) and ongoing pregnancy (RR = 0.81, 95% CI 0.68, 0.96 4 RCTs, n = 1232, I 2 = 0%) were significantly lower with biosimilar preparations versus the reference product. Rates of cumulative live birth and cumulative clinical pregnancy were also significantly lower with biosimilars versus the reference product. There was high risk of publication bias. This meta-analysis included data from RCTs evaluating the efficacy and safety of the biosimilar follitropin alfa preparations and demonstrated lower probability of live birth and pregnancy (ongoing and clinical) in couples treated with biosimilar preparations compared with the reference product. This study provides more insight into the differences between biosimilar r-hFSH preparations and the reference product than previously reported. Registration number: CRD42019121992 .
Publisher: Oxford University Press (OUP)
Date: 03-01-2023
Abstract: Several GnRH antagonist protocols are currently used during COS in the context of ART treatments however, questions remain regarding whether these protocols are comparable in terms of efficacy and safety. A systematic review followed by a pairwise and network meta-analyses were performed. The systematic review and pairwise meta-analysis of direct comparative data according to the PRISMA guidelines evaluated the effectiveness of different GnRH antagonist protocols (fixed Day 5/6 versus flexible, ganirelix versus cetrorelix, with or without hormonal pretreatment) on the probability of live birth and ongoing pregnancy after COS during ART treatment. A frequentist network meta-analysis combining direct and indirect comparisons (using the long GnRH agonist protocol as the comparator) was also performed to enhance the precision of the estimates. The systematic literature search was performed using Embase (Ovid), MEDLINE (Ovid), Cochrane Central Register of Trials (CENTRAL), SCOPUS and Web of Science (WOS), from inception until 23 November 2021. The search terms comprised three different MeSH terms that should be present in the identified studies: GnRH antagonist assisted reproduction treatment randomized controlled trial (RCT). Only studies published in English were included. The search strategy resulted in 6738 in idual publications, of which 102 were included in the systematic review (corresponding to 75 unique studies) and 73 were included in the meta-analysis. Most studies were of low quality. One study compared a flexible protocol with a fixed Day 5 protocol and the remaining RCTs with a fixed Day 6 protocol. There was a lack of data regarding live birth when comparing the flexible and fixed GnRH antagonist protocols or cetrorelix and ganirelix. No significant difference in live birth rate was observed between the different pretreatment regimens versus no pretreatment or between the different pretreatment protocols. A flexible GnRH antagonist protocol resulted in a significantly lower OPR compared with a fixed Day 5/6 protocol (relative risk (RR) 0.76, 95% CI 0.62 to 0.94, I2 = 0% 6 RCTs n = 907 participants low certainty evidence). There were insufficient data for a comparison of cetrorelix and ganirelix for OPR. OCP pretreatment was associated with a lower OPR compared with no pretreatment intervention (RR 0.79, 95% CI 0.69 to 0.92 I2 = 0% 5 RCTs, n = 1318 participants low certainty evidence). Furthermore, in the network meta-analysis, a fixed protocol with OCP resulted in a significantly lower OPR than a fixed protocol with no pretreatment (RR 0.84, 95% CI 0.71 to 0.99 moderate quality evidence). The surface under the cumulative ranking (SUCRA) scores suggested that the fixed protocol with no pretreatment is the antagonist protocol most likely (84%) to result in the highest OPR. There was insufficient evidence of a difference between fixed/flexible or OCP pretreatment/no pretreatment interventions regarding other outcomes, such as ovarian hyperstimulation syndrome and miscarriage rates. Available evidence, mostly of low quality and certainty, suggests that different antagonist protocols should not be considered as equivalent for clinical decision-making. More trials are required to assess the comparative effectiveness of ganirelix versus cetrorelix, the effect of different pretreatment interventions (e.g. progestins or oestradiol) or the effect of different criteria for initiation of the antagonist in the flexible protocol. Furthermore, more studies are required examining the optimal GnRH antagonist protocol in women with high or low response to ovarian stimulation.
Publisher: SAGE Publications
Date: 29-05-2018
Abstract: Idiopathic thrombocytopenic purpura is a relatively rare complication occurring in pregnancy, with the potential for serious maternal and fetal outcomes. Rarely, the poor response to established first-line therapies results in consideration of second-line therapies, which may have poorly understood risks to the fetus. We report two women with severe idiopathic thrombocytopenic purpura during pregnancy unresponsive to corticosteroids and intravenous immunoglobulin who were treated with romiplostim, a thrombopoietin receptor agonist. One woman with chronic idiopathic thrombocytopenic purpura had a partial response to romiplostim and suffered a post-partum haemorrhage related to uterine atony. The second woman developed severe idiopathic thrombocytopenic purpura in pregnancy and initially responded well to romiplostim. However, a lower segment Caesarean section was performed at 37 weeks for pre-ecl sia. The newborn suffered from severe idiopathic thrombocytopenic purpura and a grade 1 cerebral haemorrhage requiring intravenous immunoglobulin and platelet transfusions. Romiplostim might be a useful therapy for severe idiopathic thrombocytopenic purpura in pregnancy but requires further study.
No related grants have been discovered for Su Jen Chua.