Economic evaluation of endometrial scratching before the second IVF/ICSI treatment: a cost-effectiveness analysis of a randomized controlled trial (SCRaTCH trial).
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SUBMITTER: van Hoogenhuijze NE
PROVIDER: S-EPMC8804332 | biostudies-literature | 2022 Jan
REPOSITORIES: biostudies-literature
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Economic evaluation of endometrial scratching before the second IVF/ICSI treatment: a cost-effectiveness analysis of a randomized controlled trial (SCRaTCH trial).
van Hoogenhuijze N E NE van Eekelen R R Mol F F Schipper I I Groenewoud E R ER Traas M A F MAF Janssen C A H CAH Teklenburg G G de Bruin J P JP van Oppenraaij R H F RHF Maas J W M JWM Moll E E Fleischer K K van Hooff M H A MHA de Koning C H CH Cantineau A E P AEP Lambalk C B CB Verberg M M van Heusden A M AM Manger A P AP van Rumste M M E MME van der Voet L F LF Pieterse Q D QD Visser J J Brinkhuis E A EA den Hartog J E JE Glas M W MW Klijn N F NF van der Zanden M M Bandell M L ML Boxmeer J C JC van Disseldorp J J Smeenk J J van Wely M M Eijkemans M J C MJC Torrance H L HL Broekmans F J M FJM
Human reproduction (Oxford, England) 20220101 2
<h4>Study question</h4>Is a single endometrial scratch prior to the second fresh IVF/ICSI treatment cost-effective compared to no scratch, when evaluated over a 12-month follow-up period?<h4>Summary answer</h4>The incremental cost-effectiveness ratio (ICER) for an endometrial scratch was €6524 per additional live birth, but due to uncertainty regarding the increase in live birth rate this has to be interpreted with caution.<h4>What is known already</h4>Endometrial scratching is thought to improv ...[more]
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Project description: Not available
| S-EPMC7801792 | biostudies-literature
Project description:BackgroundIn IVF/ICSI treatment, the process of embryo implantation is the success rate-limiting step. Endometrial scratching has been suggested to improve this process, but it is unclear if this procedure increases the chance of implantation and live birth (LB) and, if so, for whom, and how the scratch should be performed.Objective and rationaleThis individual participant data meta-analysis (IPD-MA) aims to answer the question of whether endometrial scratching in women undergoing IVF/ICSI influences the chance of a LB, and whether this effect is different in specific subgroups of women. After its incidental discovery in 2000, endometrial scratching has been suggested to improve embryo implantation. Numerous randomized controlled trials (RCTs) have been conducted, showing contradicting results. Conventional meta-analyses were limited by high within- and between-study heterogeneity, small study samples, and a high risk of bias for many of the trials. Also, the data integrity of several trials have been questioned. Thus, despite numerous RCTs and a multitude of conventional meta-analyses, no conclusion on the clinical effectiveness of endometrial scratching could be drawn. An IPD-MA approach is able to overcome many of these problems because it allows for increased uniformity of outcome definitions, can filter out studies with data integrity concerns, enables a more precise estimation of the true treatment effect thanks to adjustment for participant characteristics and not having to make the assumptions necessary in conventional meta-analyses, and because it allows for subgroup analysis.Search methodsA systematic literature search identified RCTs on endometrial scratching in women undergoing IVF/ICSI. Authors of eligible studies were invited to share original data for this IPD-MA. Studies were assessed for risk of bias (RoB) and integrity checks were performed. The primary outcome was LB, with a one-stage intention to treat (ITT) as the primary analysis. Secondary analyses included as treated (AT), and the subset of women that underwent an embryo transfer (AT+ET). Treatment-covariate interaction for specific participant characteristics was analyzed in AT+ET.OutcomesOut of 37 published and 15 unpublished RCTs (7690 participants), 15 RCTs (14 published, one unpublished) shared data. After data integrity checks, we included 13 RCTs (12 published, one unpublished) representing 4112 participants. RoB was evaluated as 'low' for 10/13 RCTs. The one-stage ITT analysis for scratch versus no scratch/sham showed an improvement of LB rates (odds ratio (OR) 1.29 [95% CI 1.02-1.64]). AT, AT+ET, and low-RoB-sensitivity analyses yielded similar results (OR 1.22 [95% CI 0.96-1.54]; OR 1.25 [95% CI 0.99-1.57]; OR 1.26 [95% CI 1.03-1.55], respectively). Treatment-covariate interaction analysis showed no evidence of interaction with age, number of previous failed embryo transfers, treatment type, or infertility cause.Wider implicationsThis is the first meta-analysis based on IPD of more than 4000 participants, and it demonstrates that endometrial scratching may improve LB rates in women undergoing IVF/ICSI. Subgroup analysis for age, number of previous failed embryo transfers, treatment type, and infertility cause could not identify subgroups in which endometrial scratching performed better or worse. The timing of endometrial scratching may play a role in its effectiveness. The use of endometrial scratching in clinical practice should be considered with caution, meaning that patients should be properly counseled on the level of evidence and the uncertainties.
| S-EPMC10628489 | biostudies-literature
Project description:IntroductionEndometrial trauma commonly known as endometrial scratch (ES) has been shown to improve pregnancy rates in women with a history of repeated implantation failure undergoing in vitro fertilisation (IVF), with or without intracytoplasmic sperm injection (ICSI). However, the procedure has not yet been fully explored in women having IVF/ICSI for the first time. This study aims to examine the effect of performing an ES in the mid-luteal phase prior to a first-time IVF/ICSI cycle on the chances of achieving a clinical pregnancy and live birth. If ES can influence this success rate, there would be a significant cost saving to the National Health Service through decreasing the number of IVF/ICSI cycles necessary to achieve a pregnancy, increase the practice of single embryo transfer and consequently have a large impact on risks and costs associated with multiple pregnancies.Methods and analysisThis 30-month, UK, multicentre, parallel group, randomised controlled trial includes a 9-month internal pilot and health economic analysis recruiting 1044 women from 16 fertility units. It will follow up participants to identify if IVF/ICSI has been successful and live birth has occurred up to 6 weeks post partum. Primary analysis will be on an intention-to-treat basis. A substudy of endometrial samples obtained during the ES will assess the role of immune factors in embryo implantation. Main trial recruitment commenced on January 2017 and is ongoing.Participants randomised to the intervention group will receive the ES procedure in the mid-luteal phase of the preceding cycle prior to first-time IVF/ICSI treatment versus usual IVF/ICSI treatment in the control group, with 1:1 randomisation. The primary outcome is live birth rate after completed 24 weeks gestation.Ethics and disseminationSouth Central-Berkshire Research Ethics Committee approved the protocol. Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences.Trial registration numberISRCTN23800982; Pre-results.
| S-EPMC5961587 | biostudies-literature
Project description:Study questionWhat is the clinical-effectiveness and safety of the endometrial scratch (ES) procedure compared to no ES, prior to usual first time in vitro fertilisation (IVF) treatment?Summary answerES was safe but did not improve pregnancy outcomes when performed in the mid-luteal phase prior to the first IVF cycle, with or without intracytoplasmic sperm injection (ICSI).What is known alreadyES is an 'add-on' treatment that is available to women undergoing a first cycle of IVF, with or without ICSI, despite a lack of evidence to support its use.Study design, size, durationThis pragmatic, superiority, open-label, multi-centre, parallel-group randomised controlled trial involving 1048 women assessed the clinical effectiveness and safety of the ES procedure prior to first time IVF, with or without ICSI, between July 2016 and October 2019.Participants/materials, setting, methodsParticipants aged 18-37 years undergoing their first cycle of IVF, with or without ICSI, were recruited from 16 UK fertility clinics and randomised (1:1) by a web-based system with restricted access rights that concealed allocation. Stratified block randomisation was used to allocate participants to TAU or ES in the mid-luteal phase followed by usual IVF with or without ICSI treatment. The primary outcome was live birth after completing 24 weeks gestation within 10.5 months of egg collection.Main results and the role of chanceIn total, 1048 women randomised to TAU (n = 525) and ES (n = 523) were available for intention to treat analysis. In the ES group, 453 (86.6%) received the ES procedure. IVF, with or without ICSI, was received in 494 (94.1%) and 497 (95.0%) of ES and TAU participants respectively. Live birth rate was 37.1% (195/525) in the TAU and 38.6% (202/523) in the ES: an unadjusted absolute difference of 1.5% (95% CI -4.4% to 7.4%, P = 0.621). There were no statistical differences in secondary outcomes. Adverse events were comparable across groups.Limitations, reasons for cautionA sham ES procedure was not undertaken in the control group, however, we do not believe this would have influenced the results as objective fertility outcomes were used.Wider implications of the findingsThis is the largest trial that is adequately powered to assess the impact of ES on women undergoing their first cycle of IVF. ES was safe, but did not significantly improve pregnancy outcomes when performed in the mid-luteal phase prior to the first IVF or ICSI cycle. We recommend that ES is not undertaken in this population.Study funding/competing interest(s)Funded by the National Institute of Health Research. Stephen Walters is an National Institute for Health Research (NIHR) Senior Investigator (2018 to present) and was a member of the following during the project: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Clinical Trials and Evaluation Committee (2011-2017), NIHR HTA Commissioning Strategy Group (2012 to 2017); NIHR Programme Grants for Applied Research Committee (2020 to present); NIHR Pre doctoral Fellowship Committee (2019 to present). Dr. Martins da Silva reports grants from AstraZeneca, during the conduct of the study; and is Associate editor of Human Reproduction and Editorial Board member of Reproduction and Fertility. Dr. Bhide reports grants from Bart's Charity and grants and non-financial support from Pharmasure Pharmaceuticals outside the submitted work.Trial registration numberISRCTN number: ISRCTN23800982.Trial registration date31 May 2016.Date of first patient’s enrolment04 July 2016.
| S-EPMC8213451 | biostudies-literature
Project description:This cost-effectiveness analysis was conducted from the patient's perspective alongside a randomized controlled trial comparing corifollitropin alfa with follitropin beta for a single stimulation cycle. Only unit costs paid by patients are included in this analysis. The incremental cost-effectiveness ratio was calculated. One-way sensitivity analysis and probabilistic sensitivity analysis (PSA) were also performed. Baseline characteristics (except for the number of follicles and frozen embryos), treatment outcomes and complications were similar in the two groups. The live birth rate was comparable between the two groups, but the mean total cost per patient was higher for the corifollitropin alfa strategy (€4293) compared with the follitropin beta strategy (€4086). Costs per live birth were €13,726 and €12,511, respectively. The difference in effect between corifollitropin alfa and collitropin beta was three fewer live births, and the difference in costs was €24,048. The probability of live birth after the first and second embryo transfers and the proportion of patients who had no more frozen embryos available after non-achievement of live birth in the first or second transfer influenced the comparative cost-effectiveness of the two strategies. PSA showed that a corifollitropin alfa strategy would be rejected in up to 27.4% of scenarios. Follitropin beta 300 IU/day was more cost-effective than corifollitropin alfa 150 μg in women aged 35-42 years weighing ≥ 50 kg undergoing in-vitro fertilzation/intracytoplasmic sperm injection.
| S-EPMC7235613 | biostudies-literature
Project description: Not available
| S-EPMC8171384 | biostudies-literature
Project description:BackgroundThe positive effects of dehydroepiandrosterone (DHEA) on oocyte and embryo quality improvement are often concerned. While the results on DHEA-induced endometrial improvement are controversial.ObjectiveTo evaluate whether DHEA intervention improved endometrial function and reproductive outcomes during in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycles and to thus provide clinical recommendations.Data sourcesPubMed, Cochrane Library, EMBASE and Web of Science from database inception to 31 July 2024, without language restrictions. The references of conference proceedings and websites on clinical trials were manually checked.Study designSystematic review and meta-analysis.Study eligibility criteriaParallel-controlled randomized controlled trials (RCTs) design; women underwent IVF/ICSI, patients in the experimental group received adminstration with DHEA, whereas the control group received with or without placebo; and the outcomes included reproductive or endometrial function.Study appraisal and synthesis methodsRCTs evaluating the effects of DHEA on IVF/ICSI outcomes were included. Risk of bias and quality of evidence (QoE) were assessed according to the Cochrane Collaboration's tool and the Grading of Recommendations Assessment, Development and Evaluation system. Odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs) were assessed by random-effects or fixed-effects models. Subgroup and meta-regression analyses were used to find sources of heterogeneity. Trial sequential analysis was used to judge the stability of the outcomes. Trial sequential analysis was used in order to control for random errors.ResultsA total of 16 trials included 1973 women. DHEA treatment significantly increased endometrial thickness (MD = 0.93, CI: 0.27 to 1.60; low QoE), which helped improve clinical pregnancy rate (CPR) (OR = 1.34, 95% CI: 1.08 to 1.67; low QoE). DHEA administration also increased the quality of oocyte and embryo [including the number of oocytes retrieved (MD = 0.73, CI: 0.36 to 1.10; low QoE), oocytes fertilized (MD = 0.48, CI: 0.10 to 0.87; low QoE), transferred embryos (MD = 0.27, CI: 0.09 to 0.46; very low QoE), and high-quality embryos (MD = 0.65, CI: 0.27 to 1.03; low QoE)]. Subgroup and meta-regression analyses revealed that heterogeneity might be related to disease type, ovarian stimulation protocol, and addition time of DHEA treatment. There was insufficient evidence to reach a conclusion regarding the live birth rate/ongoing pregnancy rate, miscarriage rate, and MII oocyte number of DHEA. And no severe adverse effects were observed with DHEA administration. Due to the apparent improvemen in the CPR, women with thin endometrium might benefit from DHEA cotreament.ConclusionsDue to the limited sample size and methodological problems, the QoE was low to very low; hence, the results should be interpreted with caution. The effectiveness of DHEA requires more research before it can be considered for clinical practice.Prospero registrationCRD42023428885.
| S-EPMC11843996 | biostudies-literature
Project description:The endometrial scratch procedure is an IVF 'add-on' sometimes provided prior to the first IVF cycle. A 2019 systematic review concluded that there was insufficient evidence to show whether endometrial scratch has a significant effect on pregnancy outcomes (including live birth rate, LBR) when undertaken prior to the first IVF cycle. Further evidence was published following this review, including the Endometrial Scratch Trial (ISRCTN23800982). The objective of the current review was to synthesize and critically appraise the evidence for the clinical effectiveness and safety of the endometrial scratch procedure in women undergoing their first IVF cycle. Databases searched include MEDLINE, Embase, CINAHL and ClinicalTrials.gov. Eligible randomized controlled trials included women undergoing IVF for the first time that reported the effectiveness and/or safety of the endometrial scratch procedure; 12 studies were included. Meta-analysis showed no evidence of a significant effect of the endometrial scratch on LBR (10 trials, odds ratio [OR] 1.17, 95% confidence interval [CI] 0.76-1.79) or other pregnancy outcomes. This review confirms that there is a lack of evidence that endometrial scratch improves pregnancy outcomes, including LBR, for women undergoing their first IVF cycle. Clinicians are recommended not to perform this procedure in individuals undergoing their first cycle of IVF.
| S-EPMC9089309 | biostudies-literature
Project description:BackgroundSynchronization of follicles is key to improving ovulation stimulation with the gonadotropin-releasing hormone (GnRH) antagonist protocol. GnRH antagonist administration in the early follicular phase can quickly decrease gonadotrophin (Gn) levels and achieve downregulation before stimulation, which may improves synchronization. A previous small randomized controlled study (RCT) showed that pretreatment with a GnRH antagonist for 3 days before stimulation may increase oocyte retrieval but cannot increase the pregnancy rate. This study investigated whether the GnRH antagonist pretreatment protocol in ovulatory women can increase the synchronization of follicles and pregnancy outcomes compared with the conventional GnRH antagonist protocol.MethodsThis RCT included 136 normal ovulatory women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). Both groups were treated with recombinant follicle-stimulating hormone (r-FSH) and a flexible GnRH antagonist protocol. The women were randomized into two equal groups with or without GnRH antagonist administration from day 2 of the menstrual cycle for 3 days before stimulation. Our primary outcome was the number of retrieved oocytes. Secondary outcomes included the pregnancy rate and live birth rate.ResultsBoth groups had similar baseline characteristics. The number of retrieved oocytes in the study group was comparable to that in the control group (9.5 [8.0-13.0] vs. 11.0 [7.0-14.8], P = 0.469). There was no significant difference in the follicle size. The fertilization rate, number of good-quality embryos, implantation rate, pregnancy rate, ongoing pregnancy rate, live birth rate per embryonic transfer cycle, and miscarriage rate were similar between the two groups.ConclusionThis large RCT analysed GnRH antagonist pretreatment with the GnRH antagonist protocol applied to normal ovulatory women undergoing IVF/ICSI. The number of retrieved oocytes and pregnancy outcomes did not significantly vary.Trial registrationChinese Clinical Trial Registry, ChiCTR1800019730 . Registered 26 November 2018.
| S-EPMC8507211 | biostudies-literature
Project description:PURPOSE: To compare aneuploidy rates in first trimester pregnancy losses following IVF+/-ICSI. METHODS: A retrospective cohort analysis of karyotypes of abortuses following conventional IVF (n=159) and ICSI (n=196). RESULTS: 50.1% of losses were found to be cytogenetically abnormal among all patients undergoing IVF+/-ICSI. A significant increase in fetal aneuploidy rate was noted with increasing maternal age (<30 years=26.1% vs. 31 to 34 years.=38.2% vs. 35 to 39 years.=51.3% vs. >39 years.=65.9%). Aneuploidy rates were similar in the ICSI vs. conventional IVF groups (52.6% vs. 47.2% [p 0.31, RR 1.11, 95% CI 0.90, 1.38]). More sex chromosome anomalies were noted in the ICSI group. CONCLUSIONS: The aneuploidy rate in first trimester abortuses significantly increases with increasing maternal age. ICSI was not shown to significantly increase the aneuploidy rate. However, more sex chromosome anomalies were found among pregnancies resulting from ICSI.
| S-EPMC2654933 | biostudies-other