The Effect of Porcine Relaxin Vaginally Applied at Human Embryo Transfer in an In Vitro Fertilization Programme

MacLennan, A; Kerin, John F.; Kirby, Christine A.; Grant, P. A.; Warnes, Graham M.; Cox, Leonie; Bryant‐Greenwood, Gillian D.; Greenwood, F. C.

doi:10.1111/j.1479-828x.1985.tb00608.x

Cited by 6 publications

(5 citation statements)

References 16 publications

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“…Of the 17 013 records identified (Figure ), 21 studies (20 160 women, 4759 outcome events) were included [see Supporting Information Table S1 for excluded studies]. The number of outcome events for RCT participants included were 1055 and for non‐participants 3704.…”

Section: Resultsmentioning

confidence: 99%

“…Around half of RCTs were of poor quality mainly due to inadequacies in blinding and in description of withdrawals (Figure ); lack of transparency of randomisation introduced risk of bias in two studies . The quality of comparison between RCT participants and non‐participants was high in 18 studies; the remaining three studies had a risk of bias in the selection and performance domains …”

Section: Resultsmentioning

confidence: 99%

“…The trial interventions can be arranged into three categories: medical 12, surgical 6, and other 3. Of the 15 studies that received funding, 29,30,33,34,36,37,39,[41][42][43][44][46][47][48][49] three received funding from commercial organisations. 34,43,44 Around half of RCTs were of poor quality mainly due to inadequacies in blinding and in description of withdrawals ( Figure 3); lack of transparency of randomisation introduced risk of bias in two studies.…”

Section: Characteristics and Quality Of Included Studiesmentioning

confidence: 99%

“…29,31 The quality of comparison between RCT participants and non-participants was high in 18 studies; the remaining three studies had a risk of bias in the selection and performance domains. 29,30,40…”

Section: Characteristics and Quality Of Included Studiesmentioning

confidence: 99%

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Participation in clinical trials improves outcomes in women's health: a systematic review and meta‐analysis

Nijjar

D’Amico

Wimalaweera³

et al. 2017

BJOG

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Background Previous reviews examining the effect of participation in trials on outcomes have not consistently shown benefit. Obstetrics and gynaecology is a unique disease area posing challenges for both researchers and patients.Objectives To determine whether participation in randomised controlled trials (RCTs), compared with non-participation, has a beneficial effect on women's health.Search strategy Medline, Embase, the Cochrane Library, and PsycInfo were searched up to December 2015.Selection criteria We selected studies that reported the same clinical outcomes for participants in a women's health RCT and a comparable non-participant cohort.Data collection and analysis Data were extracted on quality, characteristics and study results. Outcomes were compared using logistic regression.Main results There were 21 relevant studies (20 160 women, 4759 outcome events). Trial participants, compared with nonparticipants, had 25% better odds of improved outcomes on average (OR 0.75; 95% CI 0.64-0.87; I 2 = 64.3%). The beneficial effect of participating in a trial was larger in comparisons where: RCTs were of high quality (OR 0.62; 95% CI 0.50-0.76) versus low (OR 0.92; 95% CI 0.74-1.16); and RCT intervention was not available to non-participants (OR 0.57; 95% CI 0.47-0.69) versus when it was (OR 1.13; 95% CI 0.89-1.44). The effect of trial participation was not influenced by effect size within the RCT (P = 0.48), whether funding was received or not (P = 0.13), whether non-participants received any treatment or not (P = 0.49), and the quality of the comparison of RCT participants with non-participants (P = 0.88).Conclusions Women participating in RCTs on average experienced better outcomes compared with those outside trials.Keywords Neonate, randomised, systematic review, trial participation, women's health.Tweetable abstract Participants in obstetric and gynaecology RCTs experience better outcomes compared with nonparticipants.Please cite this paper as: Nijjar SK, D'Amico MI, Wimalaweera NA, Cooper NAM, Zamora J, Khan KS. Participation in clinical trials improves outcomes in women's health: a systematic review and meta-analysis.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Characteristics and Quality Of Included Studiesmentioning

confidence: 99%

Section: Characteristics and Quality Of Included Studiesmentioning

confidence: 99%

See 2 more Smart Citations

Participation in clinical trials improves outcomes in women's health: a systematic review and meta‐analysis

Nijjar

D’Amico

Wimalaweera³

et al. 2017

BJOG

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“…The issue of power of the study is raised by 18 authors, but only 12 (Rock et al 1984a; MacLennan et al 1985; Belaish‐Allart et al 1987; Thomas & Cooke 1987a,b; Barratt et al 1989; Brinsmead et al 1989; Cooke & Thomas 1989; Daures et al 1990; Federman et al 1990; Johnson & Pearce 1990; Kubic et al 1990) give details of a full power calculation based on a prior specification of delta (the magnitude of the treatment effect sought) and the risk of accepting the null hypothesis in error (alpha error). Six of these trials did not reach the required calculated number of patients.…”

Section: Resultsmentioning

confidence: 99%

Infertility treatment: from cookery to science. The epidemiology of randomised controlled trials

Vandekerckhove¹,

O'Donovan²,

Lilford³

et al. 1993

BJOG

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Objectives To review the epidemiology of published randomised controlled trials in infertility treatment over the last 25 years, with special emphasis on the number and quality of trials. Design Computer literature review by MEDLINE backed up by a manual search of 41 journals. Each trial was classified according to the methodology described and quality criteria. The results were recorded in a computer database. Odds ratios (OR) and confidence intervals (CI) were calculated where the data were sufficient. Subjects Couples suffering from primary or secondary infertility. The trials studied 33 761 patients overall. Setting Institute of Epidemiology and Health Services Research, Leeds. Results Five hundred and one randomised trials in male and female infertility treatment were identified between 1966 and 1990. Pregnancy was an outcome in 291 (58%) and these were the subject of detailed analysis. Two hundred and twenty‐four (77%) and 67 (23%) ‘pregnancy trials’ were concerned, respectively, with female and male infertility. Four per cent of the trials were preceded by a sample size calculation, and the average sample size was 96 patients (range 5–933); 700 patients per group would be required to demonstrate plausible success rates for most treatments. The method of randomisation was unstated or pseudo‐randomised in 206 (71%) of trials where pregnancy was an outcome. Only 29 (5.8%) of studies were multicentre. The method of confirmation of pregnancy was omitted for 70% of papers. Cross‐over design was used in 103 (21%) of cases. Meta‐analysis is possible for selected topics such as the use of anti‐oestrogens in idiopathic oligospermia and unexplained female infertility. Eight cases of double reporting were identified. Conclusions Trials using randomised methodology were relatively few in comparison with other branches of medicine, although their use is important in the evaluation of treatment for infertility as treatment‐independent pregnancy is common. It was encouraging to note that an exponential increase in the use of this methodology occurred during the last three years, especially in association with assisted conception techniques, and meta‐analysis has become possible for selected topics. However, many trials suffer from an unrealistically small sample size, inappropriate use of cross‐over design or pseudo‐randomisation. The trend towards properly controlled studies should be encouraged but these studies should be of improved quality and organised on a multicentre or even international basis.

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Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate

Vist

Bryant

Somerville

et al. 2008

Cochrane Database of Systematic Reviews

123

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The Effect of Porcine Relaxin Vaginally Applied at Human Embryo Transfer in an In Vitro Fertilization Programme

Cited by 6 publications

References 16 publications

Participation in clinical trials improves outcomes in women's health: a systematic review and meta‐analysis

Participation in clinical trials improves outcomes in women's health: a systematic review and meta‐analysis

Infertility treatment: from cookery to science. The epidemiology of randomised controlled trials

Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate

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