Evidence of improving quality of reporting of randomized controlled trials in subfertility. Preconception counselling initiated by general practitioners in the Netherlands: reaching couples contemplating pregnancy [ISRCTN53942912]. Addressing preconception risks identified at the time of a negative pregnancy test. A randomized trial. Health professionals' and service users' interpretation of screening test results: experimental study. Pragmatic randomised controlled trial to evaluate guidelines for the management of infertility across the primary care-secondary care interface. In unselected patients, elective single embryo transfer prevents all multiples, but results in significantly lower pregnancy rates compared with double embryo transfer: a randomized controlled trial. A randomized controlled clinical trial of 2295 ultrasound-guided embryo transfers. A multicentre randomized controlled trial of expectant management versus IVF in women with Fallopian tube patency. Quality of reporting of randomized controlled trials in polycystic ovary syndrome.
The quality of randomized controlled trials (RCTs) in subfertility and their suitability for inclusion in meta-analyses have been assessed in the past and found to be insufficient. Our aim was to assess whether this quality has improved over time, particularly since the publication of the Consolidated Standards of Reporting Trials (CONSORT) statement, and to assess what proportion of trials could be included in the meta-analyses of pregnancy outcomes such as those included in Cochrane Reviews.
                A selection of subfertility trials published in 1990, 1996 and 2002 was collected from the Cochrane Menstrual Disorder and Subfertility Group (MDSG) database. Only trials published in English as full journal articles, claiming to be randomized and reporting on pregnancy outcomes, were included.
                One hundred and sixty-four trials met our inclusion criteria. Twenty-four (15%) were found not to be randomized, despite claims, and only 10 trials (6%) provided adequate details on the methods of randomization and allocation concealment. Of these, only three had sufficient details extractable to allow for an intention-to-treat analysis of the outcome 'live birth'.
                Although an improvement in some subfertility-specific issues was observed, the quality of reporting of RCTs still needs to improve to make them suitable for inclusion in meta-analyses such as those in the Cochrane Library. To maximise the potential for reducing the risk of adverse pregnancy outcomes, preconception counselling (PCC) is used to inform couples contemplating pregnancy about general and personal risk factors. Many initiatives have been developed to provide PCC, but none offers it routinely in a presumed low-risk population. The objective of the study was to investigate the extent to which women contemplating pregnancy can be reached when a PCC programme is routinely offered by general practitioners (GPs).
                30 GPs actively offered PCC to all women aged 18 to 40 over a three-year period. GPs reviewed lists of these women and excluded women with adverse social circumstances. The remaining women received an invitation for PCC. They were requested to indicate whether they were interested in PCC, and if so, when they were contemplating pregnancy. Those both interested and contemplating pregnancy within one year were invited for PCC. All pregnancies occurring within one year of an invitation were monitored. Response rates and percentages of pregnancies preceded by an invitation or actual attendance to PCC were calculated.
                Overall, 72-75% of the interested responders, who returned the risk-assessment questionnaire (80%), actually attended PCC. However, the GPs excluded a large number of women. In 2002 27% of all pregnancies occurred in the group of women who had been interested and had indicated that they hoped to get pregnant within one year. Another 33% of the pregnancies occurred in the group of women who had been excluded, 13% in the group who had not responded, and 14% in the group who had not been interested.
                A quarter of the women who became pregnant in the year after the invitation were reached in time. In order to increase this number, methods should be developed to decrease the exclusion of women by the GPs and to increase women's response. A preconception care program has the potential to assist women who want to become pregnant by advising these women about risk factors, healthy lifestyles, and assessing readiness for pregnancy. We conducted a randomized controlled trial to determine whether comprehensive preconception risk assessment at the time of a negative pregnancy test followed by referral to primary care services is effective in initiating treatment for women with preconception risk factors.
                One hundred seventy women were offered preconception risk assessment following a negative pregnancy test. Women were assigned randomly either to a usual care group or an intervention group. Women in the latter group were informed about the risks identified and received an appointment with a primary care clinician who was also informed. Women in the usual care group and their clinicians received no feedback. All charts were reviewed and the women were contacted by telephone to determine if interventions to reduce risk were offered by clinicians during the year following the assessment.
                An average of 8.96 risks were identified per woman. The proportion of women having risks in each of 12 risk categories studied ranged from 19% to 71%. One hundred women (59%) made at least one visit during the subsequent year, thus allowing the opportunity for preconception care. The proportion of these women who had a risk addressed ranged from 18% for psychosocial risks to 48% for those with fetal exposures (smoking, alcohol, and drug use). There was no difference between groups in the percentage of risks addressed.
                The notification of women and their clinicians of identified preconception risks did not improve intervention rates. A more organized intervention system including office-based protocols is needed. To investigate the accuracy of interpretation of probabilistic screening information by different stakeholder groups and whether presentation as frequencies improves accuracy.
                Between participants experimental design; participants responded to screening information embedded in a scenario.
                Regional maternity service and national conferences and training days.
                43 pregnant women attending their first antenatal appointment in a regional maternity service; 40 companions accompanying the women to their appointments; 42 midwives; 41 obstetricians. Participation rates were 56%, 48%, 89%, and 71% respectively.
                Participants estimated the probability that a positive screening test result meant that a baby actually had Down's syndrome on the basis of all the relevant information, which was presented in a scenario. They were randomly assigned to scenarios that presented the information in percentage (n = 86) or frequency (n = 83) format. They also gave basic demographic information and rated their confidence in their estimate.
                Most responses (86%) were incorrect. Obstetricians gave significantly more correct answers (although still only 34% [corrected]) than either midwives (0%) or pregnant women (9%). Overall, the proportion of correct answers was higher for presentation as frequencies (24%) than for presentation as percentages (6%), but further analysis showed that this difference occurred only in responses from obstetricians. Many health professionals were confident in their incorrect responses.
                Most stakeholders in pregnancy screening draw incorrect inferences from probabilistic information, and health professionals need to be aware of the difficulties that both they and their patients have with such information. Moreover, they should be aware that different people make different mistakes and that ways of conveying information that help some people will not help others. To investigate the effect of clinical guidelines on the management of infertility across the primary care-secondary care interface.
                Cluster randomised controlled trial.
                General practices and NHS hospitals accepting referrals for infertility in the Greater Glasgow Health Board area. Participants: All 221 general practices in Glasgow; 214 completed the trial.
                General practices in the intervention arm received clinical guidelines developed locally. Control practices received them one year later. Dissemination of the guidelines included educational meetings.
                The time from presentation to referral, investigations completed in general practice, the number and content of visits as a hospital outpatient, the time to reach a management plan, and costs for referrals from the two groups.
                Data on 689 referrals were collected. No significant difference was found in referral rates for infertility. Fewer than 1% of couples were referred inappropriately early. Referrals from intervention practices were significantly more likely to have all relevant investigations carried out (odds ratio 1.32, 95% confidence interval 1.00 to 1.75, P=0.025). 70% of measurements of serum progesterone concentrations during the midluteal phase and 34% of semen analyses were repeated at least once in hospital, despite having been recorded as normal when checked in general practice. No difference was found in the proportion of referrals in which a management plan was reached within one year or in the mean duration between first appointment and date of management plan. NHS costs were not significantly affected.
                Dissemination of infertility guidelines by commonly used methods results in a modest increase in referrals having recommended investigations completed in general practice, but there are no detectable differences in outcome for patients or reduction in costs. Clinicians in secondary care tended to fail to respond to changes in referral practice by doctors. Guidelines that aim to improve the referral process need to be disseminated and implemented so as to lead to changes in both primary care and secondary care. Elective single embryo transfer (eSET) in a selected group of patients (i.e. young patients with at least one good quality embryo) reduces the number of multiple pregnancies in an IVF programme. However, the reduced overall multiple pregnancy rate (PR) is still unacceptably high. Therefore, a randomized controlled trial (RCT) was conducted comparing eSET and double embryo transfer (DET) in an unselected group of patients (i.e. irrespective of the woman's age or embryo quality).
                Consenting unselected patients were randomized between eSET (RCT-eSET) (n = 154) or DET (RCT-DET) (n = 154). Randomization was performed just prior to the first embryo transfer, provided that at least two 2PN zygotes were available. Non-participants received our standard transfer policy [SP-eSET in a selected group of patients (n = 100), otherwise SP-DET (n = 122)].
                The ongoing PR after RCT-eSET was significantly lower as compared with RCT-DET (21.4 versus 40.3%) and the twin PR was reduced from 21.0% after RCT-DET to 0% after RCT-eSET. The ongoing PRs after SP-eSET and SP-DET did not differ significantly (33.0 versus 30.3%), with an overall twin PR of 12.9%.
                To avoid twin pregnancies resulting from an IVF treatment, eSET should be applied in all patients. The consequence would be a halving of the ongoing PR as compared with applying a DET policy in all patients. The transfer of one embryo in a selected group of good prognosis patients leads to a less drastic reduction in PR but maintains a twin PR of 12.9%. We wanted to test the hypothesis that using abdominal ultrasound at the time of embryo transfer to guide replacement, improved pregnancy rates by at least 5%.
                An RCT in a large assisted conception unit. A pilot study and power calculation suggested that at least 2000 embryo transfers were required to demonstrate a difference of 5%, for a test with 80% power and Type 1 error 0.05. Randomization, data entry and analysis were arranged independently. Randomization was stratified for age and fresh/frozen embryo transfer. Analysis was by intention to treat.
                There was no difference in clinical pregnancy or live birth rates between the two groups. The clinical pregnancy rate for ultrasound-guided embryo transfer was 22% and for non-ultrasound-guided embryo transfer was 23% (odds ratio: 0.96; 95% confidence interval: 0.79-1.18).
                We set out to determine whether ultrasound-guided embryo transfer improved clinical pregnancy rates and live birth rates in assisted conception. We used an appropriately powered RCT design. We did not demonstrate a difference. This outcome is at odds with the UKs National Institute of Clinical Excellence recommendations for fertility treatment (Fertility Assessment and Treatment for People with Fertility Problems. London, UK: RCOG Press, 2004, 112.) which used a meta-analysis of four smaller trials (range 362-800 patients, totalling 2051 embryo transfers) to conclude that ultrasound should be offered. We suggest that the current Cochrane review should be updated with data from our trial and recommend that consideration is given to accounting for heterogeneity between the included trials. Although observational studies suggest that IVF is more effective than no treatment for women with Fallopian tube patency, this has not been tested rigorously in a randomized controlled trial (RCT).
                Eligible consenting couples planning their first treatment cycle in five Canadian fertility clinics received either IVF, within 90 days of randomization, or a period of 90 days with no treatment. Random allocation was stratified by female age and sperm quality, and administered using numbered, opaque, sealed envelopes. Follow-up assessed live birth and associated morbidity.
                Sixty-eight couples were randomized to a first cycle of IVF and 71 couples had 3 months without treatment. The live birth rates were 20/68 (29%) and 1/71 (1%), respectively. The single delivery in the untreated group was of twins, as were six of the 20 IVF deliveries (30%). An average of 2.0 embryos were transferred and no triplet pregnancies resulted. The relative likelihood of delivery after allocation to IVF was 20.9-fold higher than after allocation to no treatment [95% confidence interval (CI) 2.8-155]. The presence of abnormal sperm did not reduce this likelihood. Treating four women (95% CI 3-6) with one cycle of IVF is required to achieve a single additional birth.
                This study provides a valid and up-to-date comparison for policy makers and patients as they make choices around IVF, accurately measuring and confirming a major benefit from treatment. Inadequate reporting of randomized controlled trials (RCTs) is associated with biased estimates of treatment effects. The reporting quality of RCTs involving patients with polycystic ovary syndrome (PCOS) is unknown. The purpose of this study was to assess the reporting quality of RCTs involving patients with PCOS using a standardized tool based on the Consolidated Standards of Reporting Trials (CONSORT) statement.
                We searched PubMed database for English-language RCTs involving patients with PCOS. Quality of reporting was assessed using a 24-item questionnaire based on the revised CONSORT checklist. Reporting was evaluated overall, and for pre- and post-CONSORT periods. RCTs on PCOS associated with fertility and non-fertility disturbances were also evaluated separately.
                Nine of the 24 items were reported in less than 50% of the studies, while a significant improvement (P < 0.05) was detected in 12 of 24 items (50%) over the two CONSORT periods. The RCTs on PCOS with reference to fertility seem to have adhered better to CONSORT statement than RCTs not associated to fertility.
                There is empirical evidence of suboptimal reporting quality of RCTs in PCOS. Endorsement of the CONSORT statement may optimize the reporting quality and enhance the validity of research.
No RCTs were located that assessed the effects of preconception advice on the chance of a live birth or other fertility outcomes in people who perceived that they may be infertile and were investigating the possibility of medical treatment to address subfertility. Given the lack of RCTs evaluating the effectiveness of preconception lifestyle advice for people in the afore-mentioned population, this review cannot provide guidance for clinical practice in this area. However, it does highlight the need for further research into this important subject.