Study question What cancelation policy in controlled ovarian stimulation-intrauterine insemination (COS-IUI) cycles allows to lower the multiple pregnancy rate (MPR) without decreasing the live birth rate (LBR)? Summary answer An algorithm based on the woman’s age, serum Estradiol level and number of follicles ≥14 mm on trigger day reduces the MPR without impacting LBR. What is known already While the MPR in IVF cycles has significantly decreased in the past decades, it has remained stable and relatively high in COS-IUI cycles, at around 10-15%. The main reason behind this continuously high MPR in COS-IUI cycles has been the relative inability to lower it without significantly decreasing the overall pregnancy rates. Several risk factors are associated with MP in COS-IUI cycles, and recommendations have varied between the different scientific societies, but to date, there is no consensus on the best strategy to decrease the risk of MP in COS-IUI cycles without compromising the pregnancy and live birth rates. Study design, size, duration A bicentric observational cohort study at the Angers University Hospital (group A) and the Besançon University Hospital (group B) between January 2011 to December 2019. Approximately 350-400 IUI cycles are performed yearly in each center. All patients who had a clinical pregnancy following COS-IUI during the study period were included. Our main outcome measure was the MPR and our secondary outcome measures were the clinical pregnancy (CP), miscarriage and LBR. Participants/materials, setting, methods In group A, the starting gonadotropin dose was 50-100 IU/day, and the algorithm for cycle cancelation was based on the woman’s age, serum Estradiol (E2) level, and number of follicles ≥14 mm on trigger day. In group B, the starting gonadotropin dose was 100-150 IU/day and the cancelation policy was case-by-case and physician dependent, based on the woman’s age, number of follicles ≥15 mm, and number of previous failed COS-IUI cycles, without predefined cut-offs. Main results and the role of chance We included 6582 COS-IUI cycles (3387 in group A and 3195 in group B) that resulted in 884 clinical pregnancies (790 singletons, 86 twins and 8 triplets). The MPR was significantly lower in group A compared to group B (8.1% vs 13.3%, p = 0.01). The CPR (13.4% vs 13.4%, p = 0.99), the miscarriage rate (14.5% vs 15.6%, p = 0.64) and the LBR (10.8% vs 11.9%, p = 0.16) were comparable between groups A and B. Univariate analysis showed the following factors to be predictive of the risk of MP: the treatment center (OR = 1.73 [1.12-2.68]), the number of follicles ≥10 mm (OR = 1.22 [1.11-1.36]) and ≥14 mm on trigger day (OR = 1.43[1.20-1.70]). Multivariate analysis also showed the following factors to be predictive of the MP risk: the treatment center (aOR=1.63 [1.02-2.60]), the number of follicles ≥ 10 mm (aOR=1.20 [1.07-1.34]) and ≥14 mm on trigger day (aOR=1.39 [1.16-1.66]). The cycle cancelation rate was comparable between groups A and B (7.2% vs 7.2%, p = 0.93), while cycle cancelation rate for excessive response to COS was significantly lower in group A compared to group B (19.3% vs 35.9%, p < 0.001). The rate of divergence from cancelation protocol was significantly lower in group A compared to group B (0.09% vs 1.1% p < 0.001) Limitations, reasons for caution The main limitation of our study is the retrospective design. The algorithm needs to be tested in other populations for further validation. Wider implications of the findings The use of low starting doses of gonadotropins (50-100 IU/day), and the application of a strict algorithm that takes into account the woman’s age, serum E2 level and number of follicles ≥14 mm on trigger day allows to optimize the success rates of COS-IUI cycles Trial registration number Not applicable
Study question Does an oocyte retrieval simulation training program (ORSTP) improve the clinical performance of residents ? Summary answer The ORSTP does not improve the residents’ clinical performance, but it helps lower their stress and improve their confidence during training. What is known already Simulation training currently plays an important role in medical education, and is recommended for residents and fellows in training by many international societies. Oocyte retrieval (OR) is an invasive procedure that has a direct impact on the success rate of an IVF cycle. Studies have shown that residents and fellows favor an ORSTP and find it beneficial, but few studies have assessed the actual impact of that training on their performance in clinical practice. Study design, size, duration We performed a prospective comparative study at the Angers university Hospital. We included all OR performed by residents between May 2017 and November 2020. The Simulation (S) group included OR performed by residents who had undergone an ORSTP before performing them on patients (n = 422), and the control (C) group included OR performed by residents who had not received simulation training, but had started practicing progressively on patients with attending physicians (n = 329). Participants/materials, setting, methods Residents in the S group answered a questionnaire about their impressions at the end of the rotation. Our main outcome measures were the OR rate (ORR) (number of oocytes collected/number of follicles aspirated) during the first 3 months of the rotation (total rotation duration is 6 months) in the two groups, and the satisfaction rate of residents in the S group. Secondary outcomes included ORR during each month and at the end of the rotation. Main results and the role of chance In the S group, 6 residents aspirated 657 ovaries while in the C group, 5 residents aspirated 508 ovaries. The mean ORR during the first 3 months of rotation were comparable between the S and C groups (59% vs 58%, p = 0.68). ORR during the first and second month, and at the end of the rotation were also comparable between the S and C groups (54% vs 63% (p = 0.13), 58% vs 59% (p = 0.82) et 58% vs 58% (p = 0.9), respectively). There was no significant difference in the rate of failed OR (3.3% vs 1.8%, p = 0.13) between the S and C group. There was one case of hemoperitoneum in both groups (p = 0.81). Finally, the satisfaction rate of residents in the S group was 83%. Out of the 6 residents in the S group, only one reported being stressed before the OR, and 5 were confident about the outcomes of their retrievals. Limitations, reasons for caution Our study is limited by the monocentric design and the limited number of residents included. Wider implications of the findings Even though the ORSTP did not improve the residents’ clinical performance, it had a positive psychological impact. Our findings need to be confirmed on a larger scale and in different settings in order to establish whether the ORSTP should be systematically added to the residents training programs. Trial registration number NCT0370025
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