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An Observational Retrospective Cohort Trial on 4,828 IVF Cycles Evaluating Different Low Prognosis Patients Following the POSEIDON Criteria.

ABSTRACT: Objective: To study the actual controlled ovarian stimulation (COS) management in women with suboptimal response, comparing clinical outcomes to the gonadotropins consume, considering potential role of luteinizing hormone (LH) addition to follicle-stimulating hormone (FSH). Design: Monocentric, observational, retrospective, real-world, clinical trial on fresh intra-cytoplasmic sperm injection (ICSI) cycles retrieving from 1 to 9 oocytes, performed at Humanitas Fertility Center from January 1st, 2012 to December 31st, 2015. Methods: COS protocols provided gonadotropin releasing-hormone (GnRH) agonist long, flare-up, short and antagonist. Both recombinant and urinary FSH were used for COS and LH was added according to the clinical practice. ICSI outcomes considered were: gonadotropins dosages; total, mature, injected and frozen oocytes; cumulative, transferred and frozen embryos; implantation rate; pregnancy, delivery and miscarriage rates. Outcomes were compared according to the gonadotropin regimen used during COS. Results: Our cohort showed 20.8% of low responders, defined as 1-3 oocytes retrieved and 79.2% of "suboptimal" responders, defined as 4-9 oocytes retrieved. According to recent POSEIDON stratification, cycles were divided in group 1 (6.9%), 2 (19.8%), 3 (11.7%), and 4 (61.5%). The cohort was divided in 3 groups, according to the gonadotropin's regimen. Women treated with FSH plus LH showed worst prognostic factors, in terms of age, basal FSH, AMH, and AFC. This difference was evident in suboptimal responders, whereas only AMH and AFC were different among treatment groups in low responders. Although a different result, in terms of oocytes and embryos detected, major ICSI outcomes (i.e., pregnancy and delivery rates) were similar among groups of COS treatment. Outcomes were significantly different among Poseidon groups. Implantation, pregnancy and delivery rates were significantly higher in Poseidon group 1 and progressively declined in other POSEIDON groups, reaching the worst percentage in group 4. Conclusions: In clinical practice, women with worst prognosis factors are generally treated with a combination of LH and FSH. Despite low prognosis women showed a reduced number of oocytes retrieved, the final ICSI outcome, in terms of pregnancy, is similarly among treatment group. This result suggests that the LH addition to FSH during COS could improve the quality of oocytes retrieved, balancing those differences that are evident at baseline. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03290911.

SUBMITTER: Levi-Setti PE

PROVIDER: S-EPMC6517844 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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An Observational Retrospective Cohort Trial on 4,828 IVF Cycles Evaluating Different Low Prognosis Patients Following the POSEIDON Criteria.

Levi-Setti Paolo Emanuele PE Zerbetto Irene I Baggiani Annamaria A Zannoni Elena E Sacchi Laura L Smeraldi Antonella A Morenghi Emanuela E De Cesare Raffaella R Drovanti Alessandra A Santi Daniele D

Frontiers in endocrinology 20190508

<b>Objective:</b> To study the actual controlled ovarian stimulation (COS) management in women with suboptimal response, comparing clinical outcomes to the gonadotropins consume, considering potential role of luteinizing hormone (LH) addition to follicle-stimulating hormone (FSH). <b>Design:</b> Monocentric, observational, retrospective, real-world, clinical trial on fresh intra-cytoplasmic sperm injection (ICSI) cycles retrieving from 1 to 9 oocytes, performed at Humanitas Fertility Center from ...[more]

PMID: 31139146

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Project description:Recently, perinatal outcomes and cumulative live birth rate (CLBR) have widely been utilized to assess the fertility outcomes and safety of assisted reproductive technology (ART), but more robust research is needed to address the success rates of live-healthy births resulting from this procedure, particularly for patients with low prognosis. This study aims to assess and comparative perinatal outcomes and CLBR per cycle of in vitro fertilization/Intracytoplasmic sperm injection (IVF/ICSI) between four groups of low prognosis characterized by POSEIDON criteria. A retrospective assessment was done among infertile women with a low prognosis undergoing IVF/ICSI at a reproductive center in China. Data were collected between January 2011 and December 2015 with a follow-up of at least two years, and censoring was defined by three-cycle completion, discontinuation, or having a live birth. Participants were grouped into 4 groups according to the POSEIDON classification (POSEIDON1, POSEIDON2, POSEIDON3, and POSEIDON4). The main outcomes were perinatal and obstetric outcomes with CLBR per cycle after IVF/ICSI procedure. And IVF/ICSI-technique outcomes as a secondary outcome. Statistical analyses were performed by SPSS, and a p value of < 0.05 was considered significant. A total of 461 eligible participants underwent a total of 825 IVF/ICSI cycles. POSEIDON1 had the best perinatal outcomes in terms of live births (≥ 28w) (54.8%). POSEIDON4 had a higher risk for perinatal and obstetric complications with abortion rate (9.8%); LBW (11.7%), PTD (23.5%), PROM (11.7%), and gestational diabetes (17.6%). POSEIDON2 had a high rate for malpresentation (14.2%), and cesarean delivery(57.2%), while POSEIDON3 was much associated with the occurrences of placenta previa (9.3%) compared to other groups (p value = 0.001). After adjusting odds ratio by age and BMI, POSEIDON4 had the least odds for biochemical pregnancy (p value = 0.019); and the least odds for clinical pregnancy (p value = 0.001) of the four groups. CLBR per cycle was better in POSEIDON1 and increased with an increasing number of cycles in all groups during the three cycles. Conservative CLBR after three complete cycles were 77.27%, 42.52%, 51.4% and 22.34%, while optimistic CLBR were 79.01%, 51.19%, 58.59% and 34.46% in POSEIDON1 to POSEIDON4, respectively. Younger women with low prognosis and normal ovarian reserve have a higher probability for live births and better perinatal outcomes compared with older women with poor or normal ovarian reserve. Besides, young women with low prognosis, despite ovarian reserve status, can increase their probability of conception and get relatively higher CLBR by undergoing multiple cycles of IVF/ICSI. Age is therefore considered as a critical parameter in predicting the perinatal outcome and CLBR.

Project description:OBJECTIVE:To compare success rates, associated risks and cost-effectiveness between intrauterine insemination (IUI) and in vitro fertilisation (IVF). DESIGN:Retrospective observational study. SETTING:The UK from 2012 to 2016. PARTICIPANTS:Data from Human Fertilisation and Embryology Authority's freedom of information request for 2012-2016 for IVF/ICSI (intracytoplasmic sperm injection)and IUI as practiced in 319 105 IVF/ICSI and 30 669 IUI cycles. Direct-cost calculations for maternal and neonatal expenditure per live birth (LB) was constructed using the cost of multiple birth model, with inflation-adjusted Bank of England index-linked data. A second direct-cost analysis evaluating the incremental cost-effective ratio (ICER) was modelled using the 2016 national mean (baseline) IVF and IUI success rates. OUTCOME MEASURES:LB, risks from IVF and IUI, and costs to gain 1 LB. RESULTS:This largest comprehensive analysis integrating success, risks and costs at a national level shows IUI is safer and more cost-effective than IVF treatment.IVF LB/cycle success was significantly better than IUI at 26.96% versus 11.49% (p<0.001) but the IUI success is much closer to IVF at 2.35:1, than previously considered. IVF remains a significant source of multiple gestation pregnancy (MGP) compared with IUI (RR (Relative Risk): 1.45 (1.31 to 1.60), p<0.001) as was the rate of twins (RR: 1.58, p<0.001).In 2016, IVF maternal and neonatal cost was £115 082 017 compared with £2 940 196 for IUI and this MGP-related perinatal cost is absorbed by the National Health Services. At baseline tariffs and success rates IUI was £42 558 cheaper than IVF to deliver 1LB with enhanced benefits with small improvements in IUI. Reliable levels of IVF-related MGP, OHSS (ovarian hyperstimulation syndrome), fetal reductions and terminations are revealed. CONCLUSION:IUI success rates are much closer to IVF than previously reported, more cost-effective in delivering 1 LB, and associated with lower risk of complications for maternal and neonatal complications. It is prudent to offer IUI before IVF nationally.

Project description:Study questionDo live birth outcomes differ when Patient-Oriented Strategy Encompassing IndividualizeD Oocyte Number (POSEIDON) stratified groups are compared with women with good prognosis (non-POSEIDON group) undergoing ART?Summary answerThe current study showed no significant difference in the live birth rates (LBRs) per embryo transfer between POSEIDON groups 1 and 2 when compared with women in the non-POSEIDON group undergoing ART.What is known alreadyRecently, there has been a lot of focus on the POSEIDON classification for low prognosis women undergoing ART and various management options have been advocated. For POSEIDON groups 1 and 2, low starting dose and gonadotrophin receptor polymorphism have been suggested as possible reasons for a hyporesponse, and increasing the starting gonadotrophin dose, the addition of recombinant LH and dual stimulation have been suggested as treatment options. Most of these treatment options are hypothetical in nature and need validation.Study design size durationIn the current cohort study, a total of 1425 cycles were analyzed retrospectively following a single cycle fresh embryo transfer. The study period was from January 2013 to June 2018.Participants/materials setting methodsWomen undergoing ART at a tertiary level infertility clinic were included. Clinical and treatment-related details were obtained from the hospital's electronic medical records. The ART outcomes in a non-POSEIDON group (women with an adequate ovarian reserve and/or optimal ovarian response i.e. >9 oocytes retrieved in the previous ART cycle) and a low prognosis group stratified by POSEIDON criteria were compared. We also examined the effectiveness of the modifications made in the current ART treatment protocols among women with an adequate ovarian reserve who had a history of poor/suboptimal response (POSEIDON 1 and 2).Main results and the role of chanceThere was no statistically significant difference in the LBR per embryo transfer in POSEIDON group 1 (32/109, 29%) and group 2 (17/58, 29%) when compared with the non-POSEIDON group (340/1041, 33%) (adjusted odds ratio (aOR) 0.69; 95% CI 0.37-1.27 and aOR 0.93, 95% CI 0.43-1.97, respectively), while significantly lower LBR were observed in POSEIDON groups 3 (17/97, 17.5%) and 4 (12/120, 10%) (aOR 0.49; 95% CI 0.28-0.89 and aOR 0.38, 95% CI 0.19-0.74, respectively). The gonadotrophin dose alone was increased in one-quarter of the cycles and in another 27% the dose was increased along with the protocol change among POSEIDON group 1. In POSEIDON group 2, a change in the dose alone and in combination with protocol change was performed in 5 and 41% of cycles, respectively.Limitations reasons for cautionA limitation of our study is the retrospective nature of the study with an inherent risk of unknown confounders influencing the outcomes. Other limitations are the lack of cumulative live birth data and the relatively small sample within POSEIDON group 2, which could lead to a type II error.Wider implications of the findingsThe current study showed no significant difference in the LBR between the POSEIDON groups 1 and 2 when compared with the non-POSEIDON group of women, while groups 3 and 4 had significantly lower LBR. The simple gonadotrophin/protocol changes in groups 1 and 2 resulted in LBRs comparable to women with good prognosis. These findings call for revisiting the proposed treatment strategies for POSEIDON groups 1 and 2.Study funding/competing interestsNo funding was obtained. There are no competing interests to declare.

Dataset Information

An Observational Retrospective Cohort Trial on 4,828 IVF Cycles Evaluating Different Low Prognosis Patients Following the POSEIDON Criteria.

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An Observational Retrospective Cohort Trial on 4,828 IVF Cycles Evaluating Different Low Prognosis Patients Following the POSEIDON Criteria.

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