scholarly journals Randomized Controlled Trial Evaluating the Efficacy and Cost Effectiveness of a Ready-to-Use Applicator Containing Iodine Povacrylex and Isopropyl Alcohol Compared with Conventional Skin Scrubbing and Painting in Patients Undergoing Colorectal Surgery

2021 ◽  
Vol 73 (9) ◽  
pp. 570-575
Author(s):  
Pariyada Tanjak ◽  
Benjarat Thiengtrong ◽  
Darin Lohsiriwat ◽  
Varut Lohsiriwat ◽  
Amorn Leelaratsamee ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Colorectal Surgery ◽  
Isopropyl Alcohol ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Ease Of Use ◽  
Control Group ◽  
Preparation Time ◽  
Skin Preparation ◽  
Antiseptic Solutions

Objective: The aim of this study was to evaluate the efficacy and cost-effectiveness of a ready-to-use applicatorcontaining iodine povacrylex and isopropyl alcohol (IPIA) for the prevention of surgical site infection (SSI) followingintra-abdominal surgery.Materials and Methods: The IPIA was randomly used in patients who underwent colorectal surgical procedures.The control group for comparison was a group of patients who underwent colorectal surgical procedures usingconventional skin scrubbing and painting with antiseptic solutions without IPIA. In total, 100 patients were includedin the study, randomized into 2 groups: one was applied IPIA and another group a conventional skin preparation.The outcome measurements included ease-of-use as assessed by a questionnaire, preparation time comparison,estimated skin preparation expense, adverse reactions, and rate of SSI. All the patients were visited daily up to 7 dayspostoperation or until discharge, and then 14 and 30 days postoperatively for monitoring the occurrence of SSI.Results: Of the 100 patients undergoing elective intra-abdominal surgery enrolled in the study, 51 were males and49 females, with the mean age of 63.5 ± 11.3 years. The majority of the patients had undergone colorectal cancercolectomies or rectal resections. There was no mortality. Seven patients (7%) had postoperative SSI (4 patients inthe control group and 3 patients in the IPIA group, 4% vs. 3%, p = 0.45). The bacterial cultures revealed Gramnegative-bacilli in all of the patients with SSI. The preparation time for the skin preparation was 5.48 ± 2.49 min inthe control group and 2.65 ± 1.55 min in the IPIA group (p = 0.002), without statistical significance of expenses.Conclusion: IPIA was demonstrated to be as safe and effective as conventional antiseptic solutions as a skinpreparation to prevent SSI following colorectal surgery. With good ease of use, IPIA proved more convenient thana scrubbing preparation as well as offered better cost effectiveness by significantly reducing the time and cost ofthe skin preparation.

scholarly journals Randomized Controlled Trial Evaluating the Efficacy and Cost Effectiveness of a Ready-to-Use Applicator Containing Iodine Povacrylex and Isopropyl Alcohol Compared with Conventional Skin Scrubbing and Painting in Patients Undergoing Colorectal Surgery

2021 ◽  
Vol 73 (9) ◽  
pp. 570-575
Author(s):  
Pariyada Tanjak ◽  
Benjarat Thiengtrong ◽  
Darin Lohsiriwat ◽  
Varut Lohsiriwat ◽  
Amorn Leelaratsamee ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Colorectal Surgery ◽  
Isopropyl Alcohol ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Ease Of Use ◽  
Control Group ◽  
Preparation Time ◽  
Skin Preparation ◽  
Antiseptic Solutions

Objective: The aim of this study was to evaluate the efficacy and cost-effectiveness of a ready-to-use applicatorcontaining iodine povacrylex and isopropyl alcohol (IPIA) for the prevention of surgical site infection (SSI) followingintra-abdominal surgery.Materials and Methods: The IPIA was randomly used in patients who underwent colorectal surgical procedures.The control group for comparison was a group of patients who underwent colorectal surgical procedures usingconventional skin scrubbing and painting with antiseptic solutions without IPIA. In total, 100 patients were includedin the study, randomized into 2 groups: one was applied IPIA and another group a conventional skin preparation.The outcome measurements included ease-of-use as assessed by a questionnaire, preparation time comparison,estimated skin preparation expense, adverse reactions, and rate of SSI. All the patients were visited daily up to 7 dayspostoperation or until discharge, and then 14 and 30 days postoperatively for monitoring the occurrence of SSI.Results: Of the 100 patients undergoing elective intra-abdominal surgery enrolled in the study, 51 were males and49 females, with the mean age of 63.5 ± 11.3 years. The majority of the patients had undergone colorectal cancercolectomies or rectal resections. There was no mortality. Seven patients (7%) had postoperative SSI (4 patients inthe control group and 3 patients in the IPIA group, 4% vs. 3%, p = 0.45). The bacterial cultures revealed Gramnegative-bacilli in all of the patients with SSI. The preparation time for the skin preparation was 5.48 ± 2.49 min inthe control group and 2.65 ± 1.55 min in the IPIA group (p = 0.002), without statistical significance of expenses.Conclusion: IPIA was demonstrated to be as safe and effective as conventional antiseptic solutions as a skinpreparation to prevent SSI following colorectal surgery. With good ease of use, IPIA proved more convenient thana scrubbing preparation as well as offered better cost effectiveness by significantly reducing the time and cost ofthe skin preparation.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

scholarly journals Clinical and cost effectiveness of arthritis gloves in rheumatoid arthritis (A-GLOVES): randomised controlled trial with economic analysis

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alison Hammond ◽  
Yeliz Prior ◽  
Sarah Cotterill ◽  
Chris Sutton ◽  
Elizabeth Camacho ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Recent Change ◽  
Control Group ◽  
Dominant Hand ◽  
Night Time ◽  
Hand Pain ◽  
Randomised Controlled

Abstract Background Arthritis (or compression) gloves are widely prescribed to people with rheumatoid arthritis and other forms of hand arthritis. They are prescribed for daytime wear to reduce hand pain and improve hand function, and/or night-time wear to reduce pain, improve sleep and reduce morning stiffness. However, evidence for their effectiveness is limited. The aims of this study were to investigate the clinical and cost effectiveness of arthritis gloves compared to placebo gloves on hand pain, stiffness and function in people with rheumatoid arthritis and persistent hand pain. Methods A parallel randomised controlled trial, in adults (≥ 18 years) with rheumatoid or undifferentiated inflammatory arthritis at 16 National Health Service sites in the UK. Patients with persistent hand pain affecting function and/or sleep were eligible. Randomisation (1:1) was stratified by recent change (or not) in medication, using permuted blocks of random sizes. Three-quarter-finger length arthritis gloves (Isotoner®: applying 23-32 mmHg pressure) (intervention) were compared to loose-fitting placebo gloves (Jobskin® classic: providing no/minimal pressure) (control). Both gloves (considered to have similar thermal qualities) were provided by occupational therapists. Patients and outcome assessors were blinded; clinicians were not. The primary outcome was dominant hand pain on activity (0–10) at 12 weeks, analysed using linear regression and intention to treat principles. Results Two hundred six participants were randomly assigned (103 per arm) and 163 (84 intervention: 79 control) completed 12-week follow-up. Hand pain improved by 1.0 (intervention) and 1.2 (control), an adjusted mean difference of 0.10 (95% CI: − 0.47 to 0.67; p = 0.72). Adverse events were reported by 51% of intervention and 36% of control group participants; with 6 and 7% respectively, discontinuing glove wear. Provision of arthritis gloves cost £129, with no additional benefit. Conclusion The trial provides evidence of no clinically important effect of arthritis gloves on any of the trial outcomes (hand pain, function and stiffness) and arthritis gloves are not cost-effective. The clinical and cost-effectiveness results support ceasing provision of arthritis gloves in routine clinical practice. Funding: National Institute for Health Research. Trial registration ISRCTN, ISRCTN25892131; Registered 05/09/2016: retrospectively registered.

scholarly journals Pharmacological Management of Chronic Neuropathic Pain – Consensus Statement and Guidelines from the Canadian Pain Society

2007 ◽  
Vol 12 (1) ◽  
pp. 13-21 ◽  
Author(s):  
DE Moulin ◽  
AJ Clark ◽  
I Gilron ◽  
MA Ware ◽  
CPN Watson ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Opioid Analgesics ◽  
Ease Of Use ◽  
Control Group ◽  
Pharmacological Management ◽  
Randomized Controlled ◽  
Analgesic Agents ◽  
Third Line

Neuropathic pain (NeP), generated by disorders of the peripheral and central nervous system, can be particularly severe and disabling. Prevalence estimates indicate that 2% to 3% of the population in the developed world suffer from NeP, which suggests that up to one million Canadians have this disabling condition. Evidence-based guidelines for the pharmacological management of NeP are therefore urgently needed. Randomized, controlled trials, systematic reviews and existing guidelines focusing on the pharmacological management of NeP were evaluated at a consensus meeting. Medications are recommended in the guidelines if their analgesic efficacy was supported by at least one methodologically sound, randomized, controlled trial showing significant benefit relative to placebo or another relevant control group. Recommendations for treatment are based on degree of evidence of analgesic efficacy, safety, ease of use and cost-effectiveness. Analgesic agents recommended for first-line treatments are certain antidepressants (tricyclics) and anticonvulsants (gabapentin and pregabalin). Second-line treatments recommended are serotonin noradrenaline reuptake inhibitors and topical lidocaine. Tramadol and controlled-release opioid analgesics are recommended as third-line treatments for moderate to severe pain. Recommended fourth-line treatments include cannabinoids, methadone and anticonvulsants with lesser evidence of efficacy, such as lamotrigine, topiramate and valproic acid. Treatment must be individualized for each patient based on efficacy, side-effect profile and drug accessibility, including cost. Further studies are required to examine head-to-head comparisons among analgesics, combinations of analgesics, long-term outcomes, and treatment of pediatric and central NeP.

scholarly journals Electroacupuncture with Usual Care for Patients with Non-Acute Pain after Back Surgery: Cost-Effectiveness Analysis Alongside a Randomized Controlled Trial

2020 ◽  
Vol 12 (12) ◽  
pp. 5033
Author(s):  
NamKwen Kim ◽  
Kyung-Min Shin ◽  
Eun-Sung Seo ◽  
Minjung Park ◽  
Hye-Yoon Lee
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Societal Perspective ◽  
National Health ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Acute Low Back Pain ◽  
Life Years ◽  
Back Surgery ◽  
The Cost

Electroacupuncture (EA) is used to treat pain after back surgery. Although this treatment is covered by national health insurance in Korea, evidence supporting its cost-effectiveness and contribution to the sustainability of the national health care system has yet to be published. Therefore, an economic evaluation, alongside a clinical trial, was conducted to estimate the cost-effectiveness of EA and usual care (UC) versus UC alone to treat non-acute low back pain (LBP). In total, 108 patients were recruited and randomly assigned to treatment groups; 106 were included in the final cost utility analysis. The incremental cost-effectiveness ratio of EA plus UC was estimated as 7,048,602 Korean Rate Won (KRW) per quality-adjusted life years (QALYs) from the societal perspective (SP). If the national threshold was KRW 30 million per QALY, the cost-effectiveness probability of EA plus UC was an estimated 85.9%; and, if the national threshold was over KRW 42,496,372 per QALY, the cost-effectiveness probability would be over 95% percent statistical significance. Based on these results, EA plus UC combination therapy for patients with non-acute LBP may be cost-effective from a societal perspective in Korea.

scholarly journals Periarticular Injection with Bupivacaine for Postoperative Pain Control in Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Varah Yuenyongviwat ◽  
Chaturong Pornrattanamaneewong ◽  
Thitima Chinachoti ◽  
Keerati Chareancholvanich
Keyword(s):  
Pain Control ◽  
Controlled Trial ◽  
Ease Of Use ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Periarticular Injection ◽  
Post Operative Pain ◽  
Significant Difference

Background. Local periarticular injection with bupivacaine alone in TKA has not been studied. Thus, we aimed to examine the effectiveness of local periarticular injection with bupivacaine for post-operative pain control in TKA.Method. Sixty patients undergoing TKA by a single surgeon were randomly assigned into two groups in a double-blind, placebo-controlled study. In the injection group, patients received periarticular injections with 0.25% bupivacaine before wound closure; in the control group, patients received a 0.9% normal saline injection. Both groups received the same anesthetic procedure, post-operative pain control, and rehabilitation protocol.Results. There was a significant reduction in post-operative morphine consumption in the first six hours after the operation (mean 0.9 mg and 2.43 mg,P=0.01), but there was no significant difference in post-operative morphine consumption between six hours and ninety-six hours after the operation, visual analogue scale (VAS) score, morphine side effects during the first 96 hours, length of hospital stay, or complications from morphine consumption.Conclusion. Local periarticular injection with bupivacaine alone before wound closer was shown to be an effective method to improve pain control after TKA with a few complications and ease of use.

scholarly journals Cost-Effectiveness of guideline-based stepped and collaborative care versus treatment as usual for patients with depression – a cluster-randomized trial

2020 ◽  
Author(s):  
Christian Brettschneider ◽  
Daniela Heddaeus ◽  
Maya Steinmann ◽  
Martin Härter ◽  
Birgit Watzke ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Incremental Cost ◽  
Controlled Trial ◽  
Treatment Guideline ◽  
Stepped Care ◽  
Control Group ◽  
Care Model ◽  
Treatment As Usual ◽  
Life Years ◽  
Cluster Randomized

Abstract Objective Depression is associated with major patient burden. Its treatment requires complex and collaborative approaches. A stepped-care model based on the German National Clinical Practice Guideline “Unipolar Depression” has been shown to be effective. In this study we assess the cost-effectiveness of this guideline based stepped care model versus standard care in depression. Methods This prospective cluster-randomized controlled trial included 737 depressive adult patients. Primary care practices were randomized to an intervention (IG) or a control group (CG). The intervention consisted of a four-level stepped care model. The CG received treatment as usual. A cost-utility analysis from the societal perspective with a time horizon of 12 months was performed. We used quality-adjusted life years (QALY) based on the EQ-5D as effect measure. Resource utilization was assessed by patient questionnaires. We calculated adjusted group differences in costs and effects, incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. The complete sample and subgroups based on depression severity were considered. Results In the IG, adjusted mean total costs (+5,016; SE: €2,691) and effects (+0.008 QALY; SE: 0.02) were higher than in the CG; yet, differences were not statistically significant. Significantly increased costs were found in the IG for outpatient physician services and psychiatrist services. Significantly increased total and indirect costs in the IG were found in the group with severe depression. Incremental cost-effectiveness ratios were unfavourable and the probability of cost-effectiveness was low, except for the group with moderate depression (70% for willingness-to-pay threshold of €50,000/QALY). Conclusions We found no evidence for cost-effectiveness of the intervention. However, we identified indicators that the intervention works according to the aims of the National Treatment Guideline.

scholarly journals Effectiveness and cost-effectiveness of a structured social coaching intervention for people with psychosis (SCENE): protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e050627
Author(s):  
Domenico Giacco ◽  
Agnes Chevalier ◽  
Megan Patterson ◽  
Thomas Hamborg ◽  
Rianna Mortimer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Social Activities ◽  
Social Contacts ◽  
Coaching Intervention ◽  
Randomised Controlled

IntroductionPeople with psychosis tend to have smaller social networks than both people in the general population and other people with long-term health conditions. Small social networks are associated with poor quality of life. Preliminary evidence suggests that coaching patients to increase their social contacts may be effective. In this study, we assessed whether structured social coaching improves the quality of life of patients with psychosis (primary outcome) compared with an active control group, receiving information on local social activities.Methods and analysisA structured social coaching intervention was developed based on the literature and refined through stakeholder involvement. It draws on principles from motivational interviewing, solution focused therapy and structured information giving. It is provided over a 6-month period and can be delivered by a range of different mental health professionals. Its effectiveness and cost-effectiveness are assessed in a randomised controlled trial, compared with an active control group, in which participants are given an information booklet on local social activities. Participants are aged 18 or over, have a primary diagnosis of a psychotic disorder (International Classification of Disease: F20–29) and capacity to provide informed consent. Participants are assessed at baseline and at 6, 12 and 18 months after individual randomisation. The primary outcome is quality of life at 6 months (Manchester Short Assessment of Quality of Life). We hypothesise that the effects on quality of life are mediated by an increase in social contacts. Secondary outcomes are symptoms, social situation and time spent in social activities. Costs and cost-effectiveness analyses will consider service use and health-related quality of life.Ethics and disseminationNational Health Service REC London Hampstead (19/LO/0088) provided a favourable opinion. Findings will be disseminated through a website, social media, scientific papers and user-friendly reports, in collaboration with a lived experience advisory panel.Trial registration numberISRCTN15815862.

scholarly journals Cost-effectiveness of a stepwise cardiometabolic disease prevention program: results of a randomized controlled trial in primary care

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Daphne M. Stol ◽  
Eelco A. B. Over ◽  
Ilse F. Badenbroek ◽  
Monika Hollander ◽  
Mark M. J. Nielen ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Primary Care ◽  
Cost Effectiveness ◽  
Prevention Program ◽  
Healthcare Costs ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group

Abstract Background Cardiometabolic diseases (CMD) are the major cause of death worldwide and are associated with a lower quality of life and high healthcare costs. To prevent a further rise in CMD and related healthcare costs, early detection and adequate management of individuals at risk could be an effective preventive strategy. The objective of this study was to determine long-term cost-effectiveness of stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. A computer-based simulation model was used to project long-term health benefits and cost-effectiveness, assuming the prevention program was implemented in Dutch primary care. Methods A randomized controlled trial in a primary care setting in which 1934 participants aged 45–70 years without recorded CMD or CMD risk factors participated. The intervention group was invited for stepwise CMD risk assessment through a risk score (step 1), additional risk assessment at the practice in case of increased risk (step 2) and individualized follow-up treatment if indicated (step 3). The control group was not invited for risk assessment, but completed a health questionnaire. Results of the effectiveness analysis on systolic blood pressure (− 2.26 mmHg; 95% CI − 4.01: − 0.51) and total cholesterol (− 0.15 mmol/l; 95% CI − 0.23: − 0.07) were used in this analysis. Outcome measures were the costs and benefits after 1-year follow-up and long-term (60 years) cost-effectiveness of stepwise CMD risk assessment compared to no assessment. A computer-based simulation model was used that included data on disability weights associated with age and disease outcomes related to CMD. Analyses were performed taking a healthcare perspective. Results After 1 year, the average costs in the intervention group were 260 Euro higher than in the control group and differences were mainly driven by healthcare costs. No meaningful change was found in EQ 5D-based quality of life between the intervention and control groups after 1-year follow-up (− 0.0154; 95% CI − 0.029: 0.004). After 60 years, cumulative costs of the intervention were 41.4 million Euro and 135 quality-adjusted life years (QALY) were gained. Despite improvements in blood pressure and cholesterol, the intervention was not cost-effective (ICER of 306,000 Euro/QALY after 60 years). Scenario analyses did not allow for a change in conclusions with regard to cost-effectiveness of the intervention. Conclusions Implementation of this primary care-based CMD prevention program is not cost-effective in the long term. Implementation of this program in primary care cannot be recommended. Trial registration Dutch Trial Register NTR4277, registered on 26 November 2013

scholarly journals Evaluation of GnRH antagonist pre-treatment before ovarian stimulation in a delayed-start antagonist protocol in normal ovulatory women undergoing IVF/ICSI: a randomized controlled trial (RCT)

2021 ◽  
Author(s):  
Yisheng Zhang ◽  
Liling Liu ◽  
Jie Qin ◽  
Hongyi Huang ◽  
Lintao Xue ◽  
...  
Keyword(s):  
Pregnancy Rate ◽  
Live Birth ◽  
Pregnancy Outcomes ◽  
Gnrh Antagonist ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Control Group ◽  
Gnrh Antagonist Protocol ◽  
Pre Treatment ◽  
Antagonist Protocol

Abstract Background: Synchronization of follicles is key to improving ovulation stimulation with the GnRH antagonist protocol. GnRH antagonist administration in the early follicular phase can quickly decrease gonadotrophin (Gn) levels and achieve downregulation before stimulation, which improves synchronization. A small RCT showed that pre-treatment with a GnRH antagonist for three days before stimulation might increase oocyte retrieval but cannot increase the pregnancy rate. This study investigated whether the "delayed-start" protocol in ovulatory women can increase the synchronization of follicles and pregnancy outcomes compared with the conventional GnRH antagonist protocol.Methods: This RCT included 136 normal ovulatory women undergoing IVF/ICSI. Both groups were treated with recombinant FSH (r-FSH) and a flexible GnRH antagonist protocol. The women were randomized into two equal groups with or without GnRH antagonist from day 2 of the menstrual cycle. Our primary outcome was the number of oocytes retrieved. Secondary outcomes included the pregnancy and live birth rates.Results: Both groups had similar baseline characteristics. The number of oocytes retrieved 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 statistical significance among the follicular size differences. The fertilization rate, number of good-quality embryos, implantation rate, pregnancy rate, ongoing pregnancy rate, live birth rate per ET cycle, and miscarriage rate were all similar between the two groups.Conclusion: This large RCT analysed the "delayed-start" GnRH antagonist protocol applied to normal ovulatory women performing IVF/ICSI. The number of oocytes retrieved and pregnancy outcomes did not vary significantly. Future trials need to confirm these findings.Trial registration: Chinese Clinical Trial Registry, ChiCTR1800019730. Registered 26 November 2018,http://www.chictr.org.cn/showproj.aspx?proj=29969.

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