scholarly journals Predicting the chances of having a baby with or without treatment at different time points in couples with unexplained subfertility

2019 ◽  
Vol 34 (6) ◽  
pp. 1126-1138 ◽  
Author(s):  
D J McLernon ◽  
A J Lee ◽  
A Maheshwari ◽  
R van Eekelen ◽  
N van Geloven ◽  
...  
Keyword(s):  
Prediction Model ◽  
Live Birth ◽  
Prediction Models ◽  
Conflicts Of Interest ◽  
Intrauterine Insemination ◽  
Dynamic Assessment ◽  
Expectant Management ◽  
Fertility Treatment ◽  
In Vitro Fertilisation ◽  
Natural Conception

Abstract STUDY QUESTION Can we develop a prediction model that can estimate the chances of conception leading to live birth with and without treatment at different points in time in couples with unexplained subfertility? SUMMARY ANSWER Yes, a dynamic model was developed that predicted the probability of conceiving under expectant management and following active treatments (in vitro fertilisation (IVF), intrauterine insemination with ovarian stimulation (IUI + SO), clomiphene) at different points in time since diagnosis. WHAT IS KNOWN ALREADY Couples with no identified cause for their subfertility continue to have a realistic chance of conceiving naturally, which makes it difficult for clinicians to decide when to intervene. Previous fertility prediction models have attempted to address this by separately estimating either the chances of natural conception or the chances of conception following certain treatments. These models only make predictions at a single point in time and are therefore inadequate for informing continued decision-making at subsequent consultations. STUDY DESIGN, SIZE, DURATION A population-based study of 1316 couples with unexplained subfertility attending a regional clinic between 1998 and 2011. PARTICIPANTS/MATERIALS, SETTING, METHODS A dynamic prediction model was developed that estimates the chances of conception within 6 months from the point when a diagnosis of unexplained subfertility was made. These predictions were recomputed each month to provide a dynamic assessment of the individualised chances of conception while taking account of treatment status in each month. Conception must have led to live birth and treatments included clomiphene, IUI + SO, and IVF. Predictions for natural conception were externally validated using a prospective cohort from The Netherlands. MAIN RESULTS AND THE ROLE OF CHANCE A total of 554 (42%) couples started fertility treatment within 2 years of their first fertility consultation. The natural conception leading to live birth rate was 0.24 natural conceptions per couple per year. Active treatment had a higher chance of conception compared to those who remained under expectant management. This association ranged from weak with clomiphene to strong with IVF [clomiphene, hazard ratio (HR) = 1.42 (95% confidence interval, 1.05 to 1.91); IUI + SO, HR = 2.90 (2.06 to 4.08); IVF, HR = 5.09 (4.04 to 6.40)]. Female age and duration of subfertility were significant predictors, without clear interaction with the relative effect of treatment. LIMITATIONS, REASONS FOR CAUTION We were unable to adjust for other potentially important predictors, e.g. measures of ovarian reserve, which were not available in the linked Grampian dataset that may have made predictions more specific. This study was conducted using single centre data meaning that it may not be generalizable to other centres. However, the model performed as well as previous models in reproductive medicine when externally validated using the Dutch cohort. WIDER IMPLICATIONS OF THE FINDINGS For the first time, it is possible to estimate the chances of conception following expectant management and different fertility treatments over time in couples with unexplained subfertility. This information will help inform couples and their clinicians of their likely chances of success, which may help manage expectations, not only at diagnostic workup completion but also throughout their fertility journey. STUDY FUNDING/COMPETING INTEREST(S) This work was supported by a Chief Scientist Office postdoctoral training fellowship in health services research and health of the public research (ref PDF/12/06). B.W.M. is supported by an NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck, and Guerbet. None of the other authors declare any conflicts of interest.

scholarly journals Preconception leukocyte telomere length and pregnancy outcomes among women with demonstrated fecundity

2021 ◽  
Author(s):  
Alexandra C Purdue-Smithe ◽  
Keewan Kim ◽  
Victoria C Andriessen ◽  
Anna Z Pollack ◽  
Lindsey A Sjaarda ◽  
...  
Keyword(s):  
Telomere Length ◽  
Live Birth ◽  
Pregnancy Outcomes ◽  
Pregnancy Loss ◽  
Conflicts Of Interest ◽  
Cox Proportional Hazards ◽  
Fertility Treatment ◽  
Leukocyte Telomere Length ◽  
History Of ◽  
Natural Conception

Abstract STUDY QUESTION Is preconception leukocyte telomere length associated with fecundability, pregnancy loss and live birth among women attempting natural conception with a history of 1–2 prior pregnancy losses? SUMMARY ANSWER Preconception leukocyte telomere length is not associated with fecundability, pregnancy loss or live birth. WHAT IS KNOWN ALREADY As women increasingly delay childbearing, accessible preconception biomarkers to predict pregnancy outcomes among women seeking natural conception could improve preconception counseling. Findings of small case–control or cross-sectional studies suggest that telomere attrition is associated with adverse pregnancy outcomes among women undergoing fertility treatment, but prospective studies in non-clinical populations are lacking. STUDY DESIGN, SIZE, DURATION Participants included 1228 women aged 18–40 years with a history of 1–2 prior pregnancy losses who were recruited at four university medical centers (2006–2012). PARTICIPANTS/MATERIALS, SETTING, METHODS Preconception leukocyte telomere length was measured at baseline using PCR and reported as a ratio (T/S) in relation to population-specific standard reference DNA. Women were followed for up to six cycles while attempting to conceive. Associations of telomere length with fecundability, live birth and pregnancy loss were estimated using discrete Cox proportional hazards models and log-binomial models. MAIN RESULTS AND THE ROLE OF CHANCE After adjustment for age, BMI, smoking and other factors, preconception telomere length was not associated with fecundability (Q4 vs Q1 FOR = 1.00; 95% CI = 0.79, 1.27), live birth (Q4 vs Q1 RR = 1.00; 95% CI = 0.85, 1.19), or pregnancy loss (Q4 vs Q1 RR = 1.12; 95% CI = 0.78, 1.62). LIMITATIONS, REASONS FOR CAUTION Telomere length was measured in leukocytes, which is an accessible tissue in women attempting natural conception but may not reflect telomere length in oocytes. Most women were younger than 35 years, limiting our ability to evaluate associations among older women. Participants had a history of 1–2 prior pregnancy losses; therefore, our findings may not be widely generalizable. WIDER IMPLICATIONS OF THE FINDINGS Despite prior research suggesting that telomere length may be associated with pregnancy outcomes among women seeking fertility treatment, our findings suggest that leukocyte telomere length is not a suitable biomarker of pregnancy establishment or maintenance among women attempting natural conception. STUDY FUNDING/COMPETING INTEREST(S) This research was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (National Institutes of Health, Bethesda, MD, USA; contract numbers HHSN267200603423, HHSN267200603424 and HHSN267200603426). The authors have no conflicts of interest to disclose. TRIAL REGISTRATION NUMBER The trial was registered with ClinicalTrials.gov, number NCT00467363.

P–728 Can in couples with unexplained infertility the use of a prediction model to triage assisted reproduction technology save costs?

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
D K Nguyen ◽  
S OLeary ◽  
M A Gadalla ◽  
R Wang ◽  
W Li ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Prediction Model ◽  
Live Birth ◽  
Birth Rate ◽  
Prognostic Model ◽  
Live Birth Rate ◽  
Good Prognosis ◽  
Unexplained Infertility ◽  
Usual Model ◽  
Natural Conception

Abstract Study question Can in couples with unexplained infertility a prognosis-tailored management strategy, that delays treatment if natural conception prospects are good, reduce costs without affecting live-birth rate? Summary answer In couples with unexplained infertility, use of a prognostic tool for natural conception followed by expectant management in good-prognosis couples is cost-effective. What is known already Few countries have guidelines for the assessment of the likelihood of natural conception to determine access to publicly funded ART. In the Netherlands and New-Zealand, couples with unexplained infertility who have a good prognosis for natural conception are encouraged to delay starting ART. However, the cost-effectiveness of this prognosis-tailored treatment strategy has not been determined. Study design, size, duration We studied couples with unexplained infertility to compare a prognosis-tailored strategy to care-as-usual. In the prognosis-tailored strategy, couples were assessed using Hunault’s prediction model. In good-prognosis couples (12-months natural conception >40%), outcomes without ART were modelled by censoring observations after start of ART. We then assumed that poor-prognosis couples (<40% natural conception) were treated, while good-prognosis couples delayed the start of treatment for 12 months. Data for the care-as-usual model were based on real observations. Participants/materials, setting, methods We studied 272 couples with unexplained infertility. Costs of in vitro fertilisation (IVF) and intra-uterine insemination (IUI) were calculated based on the out-of-pocket costs and Australian Medicare costs. In a cost-effectiveness model, we compared costs and effects of both strategies. Main results and the role of chance The prognostic model classified 272 couples with unexplained infertility as favourable (N = 107 (39.3%) or unfavourable prognosis (N = 165 (60.7%)) for natural conception. In the prognosis-tailored strategy, the cumulative live-birth rate was 71.1% (95% CI 64.7% - 76.4%) while the number of ART cycles was 393 (353 IVF; 40 IUI). In care-as-usual strategy, the cumulative conception rate leading to live-birth for the cohort of 272 couples, who underwent a total of 398 IVF cycles and 48 IUI cycles, was 72.1% (95% CI 65.7% - 77.4%). Mean time to conception leading to live birth was 388 days in the prognosis-tailored strategy and 419 days in the care-as-usual strategy. This translated for the 272 couples into potential savings of 45 IVF cycles and eight IUI cycles, which cost a total of AUD$ 125,817 for out-of-pocket and AUD$ 264,497 for Australian Medicare. The average cost savings per couple was AUD$ 1,435 (out-of-pocket AUD$ 463 per couple and Australian Medicare AUD$ 962 per couple). The incremental cost-effectiveness ratio, which was calculated as the total costs per additional live-births, was AUD$ 143,497 per additional live birth. Limitations, reasons for caution This study was limited to couples at a single IVF clinic. The modelling was also based on several key assumptions, particularly the number of fresh and frozen embryo transfer cycles for each couple. Wider implications of the findings: Our results show that in couples with unexplained infertility the use of a prognostic model guiding the start of an IVF-treatment reduces costs without compromising live birth rates. Trial registration number Not applicable

scholarly journals A systematic review of the quality of clinical prediction models in in vitro fertilisation

2020 ◽  
Vol 35 (1) ◽  
pp. 100-116 ◽  
Author(s):  
M B Ratna ◽  
S Bhattacharya ◽  
B Abdulrahim ◽  
D J McLernon
Keyword(s):  
Systematic Review ◽  
Live Birth ◽  
Prediction Models ◽  
Conflicts Of Interest ◽  
External Validation ◽  
Post Treatment ◽  
Treatment Model ◽  
Clinical Prediction ◽  
Clinical Prediction Models

Abstract STUDY QUESTION What are the best-quality clinical prediction models in IVF (including ICSI) treatment to inform clinicians and their patients of their chance of success? SUMMARY ANSWER The review recommends the McLernon post-treatment model for predicting the cumulative chance of live birth over and up to six complete cycles of IVF. WHAT IS KNOWN ALREADY Prediction models in IVF have not found widespread use in routine clinical practice. This could be due to their limited predictive accuracy and clinical utility. A previous systematic review of IVF prediction models, published a decade ago and which has never been updated, did not assess the methodological quality of existing models nor provided recommendations for the best-quality models for use in clinical practice. STUDY DESIGN, SIZE, DURATION The electronic databases OVID MEDLINE, OVID EMBASE and Cochrane library were searched systematically for primary articles published from 1978 to January 2019 using search terms on the development and/or validation (internal and external) of models in predicting pregnancy or live birth. No language or any other restrictions were applied. PARTICIPANTS/MATERIALS, SETTING, METHODS The PRISMA flowchart was used for the inclusion of studies after screening. All studies reporting on the development and/or validation of IVF prediction models were included. Articles reporting on women who had any treatment elements involving donor eggs or sperm and surrogacy were excluded. The CHARMS checklist was used to extract and critically appraise the methodological quality of the included articles. We evaluated models’ performance by assessing their c-statistics and plots of calibration in studies and assessed correct reporting by calculating the percentage of the TRIPOD 22 checklist items met in each study. MAIN RESULTS AND THE ROLE OF CHANCE We identified 33 publications reporting on 35 prediction models. Seventeen articles had been published since the last systematic review. The quality of models has improved over time with regard to clinical relevance, methodological rigour and utility. The percentage of TRIPOD score for all included studies ranged from 29 to 95%, and the c-statistics of all externally validated studies ranged between 0.55 and 0.77. Most of the models predicted the chance of pregnancy/live birth for a single fresh cycle. Six models aimed to predict the chance of pregnancy/live birth per individual treatment cycle, and three predicted more clinically relevant outcomes such as cumulative pregnancy/live birth. The McLernon (pre- and post-treatment) models predict the cumulative chance of live birth over multiple complete cycles of IVF per woman where a complete cycle includes all fresh and frozen embryo transfers from the same episode of ovarian stimulation. McLernon models were developed using national UK data and had the highest TRIPOD score, and the post-treatment model performed best on external validation. LIMITATIONS, REASONS FOR CAUTION To assess the reporting quality of all included studies, we used the TRIPOD checklist, but many of the earlier IVF prediction models were developed and validated before the formal TRIPOD reporting was published in 2015. It should also be noted that two of the authors of this systematic review are authors of the McLernon model article. However, we feel we have conducted our review and made our recommendations using a fair and transparent systematic approach. WIDER IMPLICATIONS OF THE FINDINGS This study provides a comprehensive picture of the evolving quality of IVF prediction models. Clinicians should use the most appropriate model to suit their patients’ needs. We recommend the McLernon post-treatment model as a counselling tool to inform couples of their predicted chance of success over and up to six complete cycles. However, it requires further external validation to assess applicability in countries with different IVF practices and policies. STUDY FUNDING/COMPETING INTEREST(S) The study was funded by the Elphinstone Scholarship Scheme and the Assisted Reproduction Unit, University of Aberdeen. Both D.J.M. and S.B. are authors of the McLernon model article and S.B. is Editor in Chief of Human Reproduction Open. They have completed and submitted the ICMJE forms for Disclosure of potential Conflicts of Interest. The other co-authors have no conflicts of interest to declare. REGISTRATION NUMBER N/A

scholarly journals Infertility and the excruciating pursuit of motherhood

2021 ◽  
pp. 01-02
Author(s):  
Urmila G
Keyword(s):  
Intracytoplasmic Sperm Injection ◽  
Assisted Reproductive Technologies ◽  
Intrauterine Insemination ◽  
Reproductive Technologies ◽  
Infertility Treatment ◽  
In Vitro Fertilisation ◽  
Natural Conception ◽  
Graphic Description

What’s a Lemon Squeezer Doing in My Vagina? is a memoir of Rohini S Rajagopal’s excruciating five-year long fight with infertility and her journey to motherhood. After several failed attempts at natural conception and many negative home pregnancy tests, the author and her husband Ranjith visit a fertility centre in Bangalore. Rajagopal delivers a graphic description of the physical and emotional unpleasantness of her infertility treatment and also gives a vivid account of her experiences with the assisted reproductive technologies (ARTs) such as the intrauterine insemination (IUIs), in-vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). Intrauterine Insemination (IUI) is facilitated by directly injecting a man’s sperm into the woman’s uterus around the time the eggs emerge from the ovaries.

scholarly journals Cumulative live birth rates over multiple complete cycles of in vitro fertilisation cycles: ten-year cohort study of 20687 women following freeze-all strategy

2020 ◽  
Author(s):  
Qianqian Zhu ◽  
Bian Wang ◽  
Jiaying Lin ◽  
Mingru Yin ◽  
yun Wang ◽  
...  
Keyword(s):  
Cohort Study ◽  
Live Birth ◽  
Birth Rate ◽  
Prediction Models ◽  
Live Birth Rate ◽  
In Vitro Fertilisation ◽  
Cumulative Live Birth Rate ◽  
Complete Cycle ◽  
Cumulative Live Birth

Abstract Background For patients embarking on in vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI), one of the most concerned problems is their chance of a live-birth. The cumulative live birth rate (CLBR) after IVF has been reported in recent years; however these studies were all about conventional IVF strategy, the CLBRs following freeze-all strategy has not been reported. Methods This was a retrospective cohort study. A total of 20687 women undergoing their first and following IVF cycles during the period from January 1, 2007 through March 31, 2016 were included in this study. The primary Outcomes of the present study were presented in three types: the live birth rate per complete cycle, the conservative CLBR and the optimal CLBR. Results The CLBR increased from 50.74% for the first complete cycle to 64.41% after seven complete cycles,and varied by age category. The CLBR after five complete cycles declined from 77.11% for women younger than 31 years, to 8.63% for women older than 40 years. The predictors of live birth over multiple complete cycles for patients embarking on IVF following freeze-all strategy were women’s age and causes of infertility. In the model constructed for patients finishing the first complete cycle, the number of oocyte retrieved at complete cycle one also played an important predictive role. Conclusions Among women undergoing IVF following freeze-all strategy, the CLBR after seven complete IVF cycles was 84.77% if there were no barriers to continue the IVF treatment, with variation by age. Two prediction models were developed to estimate their probability of having a baby over multiple complete IVF cycles with freeze-all strategy among patients before starting IVF and patients after the first complete cycle, which is critical for patients to make treatment decisions and preparations physically, emotionally and financially.

Pregnancy Rates after Intrauterine Insemination in Moderate to Severe Endometriosis: A Systematic Review and Meta-analysis of Observational Studies

2017 ◽  
Vol 9 (3) ◽  
pp. 158-167
Author(s):  
Lisette E.E. Van Der Houwen ◽  
Anneke M.F. Schreurs ◽  
Roel Schats ◽  
Pam Kaspers ◽  
Cornells B. Lambalk ◽  
...  
Keyword(s):  
Systematic Review ◽  
Live Birth ◽  
Primary Outcome ◽  
Intrauterine Insemination ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Expectant Management ◽  
Pregnancy Rates ◽  
Clinical Pregnancy ◽  
Cochrane Library

To evaluate the efficacy and safety of intrauterine insemination (IUI) in moderate to severe endometriosis patients, a systematic review and meta-analysis was conducted since the role of this treatment strategy in these patients is a matter of debate in the literature. Systematic searches were performed in PubMed, EMBASE, Cinahl, and The Cochrane Library from inception to September 1, 2016. Studies including moderate to severe endometriosis patients reporting pregnancy rates after IUI were selected. The primary outcome was live birth after IUI treatment compared to expectant management. Secondary noncomparative outcomes were live birth and clinical pregnancy, which were presented as weighed mean pregnancy rates. Nineteen articles (2 unclear design, 11 retrospective, 6 prospective) were included for the analysis. Our primary outcome measure was only addressed by one study, showing an odds ratio of 1.77 (95% confidence interval [CI], 0.86–3.63) on live birth favoring IUI versus no treatment. The calculated weighed mean live birth and clinical pregnancy rate per patient was 20.3% (95% CI, 11.2–29.4) and 32.7% (95% CI, 21.3– 44.0), respectively. This meta-analysis of observational data showed that IUI could be a feasible treatment in moderate to severe endometriosis. Whether this treatment should be structurally offered prior to in vitro fertilization needs to be investigated in a randomized, controlled trial, including time-to-pregnancy, safety, and cost-effectiveness.

Unexplained infertility and expectant management in women aged 39 or above: is it acceptable to ask couples to wait one year before receiving IVF? A retrospective cohort study

2020 ◽  
Author(s):  
Andrea Roberto Carosso ◽  
Rik van EEKELEN ◽  
Alberto Revelli ◽  
Stefano CANOSA ◽  
Noemi MERCALDO ◽  
...  
Keyword(s):  
In Vitro Fertilization ◽  
Live Birth ◽  
Expectant Management ◽  
Unexplained Infertility ◽  
Vitro Fertilization ◽  
Age Related ◽  
Significant Difference ◽  
Natural Conception ◽  
One Year

Abstract Background: in older women, it is difficult to distinguish between ‘true’ unexplained infertility and age-related infertility. Unexplained infertile couples can have further expectant management before starting assisted reproductive treatments to avoid unnecessary, invasive and expensive treatment. However, ovarian reserve rapidly declines after 39 years or more, as the live birth rate after in vitro fertilization. It is thus uncertain if such a waiting policy, is also appropriate for women of advanced age.Methods: couples who had access to a waiting list for approximately one year before receiving reimbursed public IVF were compared with those paying for access to immediate private treatment at the IVF unit of S. Anna academic hospital and its private appendix. To allow for comparisons between these two strategies, we followed up couples who opted to pay for one year after the last embryo transfer from their first cycle. Clinical procedures regarding diagnosis and treatment were the same for both groups. We calculated the proportion of live births in both groups and compared these using a two-sample Z test for equality of proportions. The imbalance between these groups in terms of prognosis was accounted for using inverse probability weighting.Results: 635 couples were evaluated. Out of 359 couples in the immediate group, 70 (19.5%) had a live birth of which 11 after natural conception and 59 after IVF. Out of 276 couples in the waiting group, 57 (20.7%) had a live birth of which 37 after natural conception and 20 after IVF. There was no statistically significant difference between the two strategies in terms of the cLBR (19.5% immediate versus 20.7% waiting, 95% CI for difference: -0.07to 0.05), also after weighting (16.8% immediate versus 26.6% waiting, bootstrap 95%, CI for difference: -0.20 to 0.01).Conclusion(s): the cLBR for the ‘waiting before in vitro fertilization’ and the ‘immediate’ strategies were similar. Further studies are necessary to validate these findings and to better characterize these patients in order to individualize treatment and optimize economic resources, particularly in a setting of publicly-funded IVF.Trial registration: retrospectively registered

P–753 A randomised controlled trial comparing expectant management versus intrauterine insemination in couples with unexplained subfertility and a poor prognosis for natural conception

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
J Wessel ◽  
M Mochtar ◽  
H Verhoeve ◽  
J Maas ◽  
J P D Bruin ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Poor Prognosis ◽  
Intrauterine Insemination ◽  
Controlled Trial ◽  
Expectant Management ◽  
Pregnancy Rates ◽  
Ongoing Pregnancy ◽  
Management Group ◽  
Natural Conception ◽  
Randomised Controlled

Abstract Study question Does 6 months expectant management reduces ongoing pregnancy rates compared to intrauterine insemination with ovarian stimulation (IUI-OS) in couples with unexplained subfertility? Summary answer In couples with unexplained subfertility and a poor prognosis for natural conception, 6 months of expectant management decreases ongoing pregnancy rates as compared to IUI-OS. What is known already In couples with unexplained subfertility and a poor prognosis, IUI-OS is a first line treatment. We have previously shown that in couples with unexplained subfertility and a good prognosis for natural conception (>30% in 12 months), 6 months expectant management does not reduce pregnancy changes. However, in couples with a poor prognosis for natural conception, effectiveness of IUI-OS is uncertain. Study design, size, duration We performed a non-inferiority multicentre randomised controlled trial (RCT) within the infrastructure of the Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynaecology. We studied couples with unexplained subfertility and a poor prognosis for natural conception. The couples were allocated in a 1:1 ratio to six months expectant management or six months IUI-OS with either clomiphene citrate or gonadotrophins. Participants/materials, setting, methods We intended to include 1091 couples. The trial was halted pre-maturely due to slow inclusion after randomisation of 178 couples. The primary outcome was ongoing pregnancy leading to a live birth with multiple pregnancy and miscarriage rate as important secondary outcomes. We calculated relative risks with 95% CI and a corresponding hazard-rate for ongoing-pregnancy-over-time based on intention-to-treat. Main results and the role of chance Between October 2016 and September 2020 92 couples were allocated to expectant management and 86 to IUI-OS. Baseline characteristics were equally distributed. Mean female age was 34 years, median duration of subfertility was 21 months. Within 6 months after randomisation, women allocated to expectant management had a lower ongoing pregnancy rate than women allocated to IUI-OS (12/92 [13.0%] vs 29/86 women [33.7%], risk ratio 0.39 (95%CI 0.21 to 0.71)). There were two ongoing twin pregnancies in the expectant management group versus none in the IUI-OS group. Of 15 clinical pregnancies in the expectant management group three miscarried (20%), of 36 clinical pregnancies in the IUI-OS group seven miscarried (19.4%) (RR 1.03 (95% CI 0.31 to 3.45)). For the outcome ongoing pregnancy, the hazard ratio for expectant management versus IUI-OS was 0.34 (95%CI 0.18 to 0.67). Limitations, reasons for caution Our trial did not reach the planned sample size and therefore the results are limited by the number of participants. As 8 women are still pregnant, in this abstract we report ongoing pregnancy rates. Live birth rates will be presented at the conference. Wider implications of the findings: In couples with unexplained subfertility and a poor prognosis for natural conception, expectant management is inferior to IUI-OS. We advise the basic work-up for subfertility to contain a prognostic assessment, and when subfertility is unexplained and natural fertility prospects are poor IUI-OS should be the preferred treatment. Trial registration number NTR5599

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