Improving Reporting of Clinical Studies Using the POSEIDON Criteria: POSORT Guidelines

Esteves, Sandro C.; Conforti, Alessandro; Sunkara, Sesh Kamal; Carbone, Luigi; Picarelli, Silvia; Vaiarelli, Alberto; Cimadomo, Danilo; Rienzi, Laura; Ubaldi, Filippo Maria; Zullo, Fulvio; Andersen, Claus Yding; Orvieto, Raoul; Humaıdan, Peter

doi:10.3389/fendo.2021.587051

Cited by 19 publications

(11 citation statements)

References 84 publications

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“…POSEIDON patients are presumed to be at a higher risk of failing to achieve a live birth after IVF/ICSI treatment than normal responders with an adequate ovarian reserve. The cumulative delivery rate (CDR) per initiated/aspiration cycle after the transfer of all fresh and frozen–thawed/warmed embryos has been suggested to be the critical endpoint that sets these groups apart ( Esteves et al , 2021a ). This metric is increasingly being recognized to be an appropriate way to report ART success ( Moragianni and Penzias, 2010 ; Maheshwari et al , 2015 ) and has been selected as a critical efficacy outcome in the ESHRE 2019 guideline on ovarian stimulation for IVF/ICSI (Ovarian Stimulation TEGGO et al , 2020).…”

Section: Introductionmentioning

confidence: 99%

Cumulative delivery rate per aspiration IVF/ICSI cycle in POSEIDON patients: a real-world evidence study of 9073 patients

Esteves¹,

Yaralı́

Vuong

et al. 2021

Human Reproduction

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STUDY QUESTION What is the cumulative delivery rate (CDR) per aspiration IVF/ICSI cycle in low-prognosis patients as defined by the Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number (POSEIDON) criteria? SUMMARY ANSWER The CDR of POSEIDON patients was on average ∼50% lower than in normal responders and varied across POSEIDON groups; differences were primarily determined by female age, number of embryos obtained, number of embryo transfer (ET) cycles per patient, number of oocytes retrieved, duration of infertility, and BMI. WHAT IS KNOWN ALREADY The POSEIDON criteria aim to underline differences related to a poor or suboptimal treatment outcome in terms of oocyte quality and quantity among patients undergoing IVF/ICSI, and thus, create more homogenous groups for the clinical management of infertility and research. POSEIDON patients are presumed to be at a higher risk of failing to achieve a live birth after IVF/ICSI treatment than normal responders with an adequate ovarian reserve. The CDR per initiated/aspiration cycle after the transfer of all fresh and frozen–thawed/warmed embryos has been suggested to be the critical endpoint that sets these groups apart. However, no multicenter study has yet substantiated the validity of the POSEIDON classification in identifying relevant subpopulations of patients with low-prognosis in IVF/ICSI treatment using real-world data. STUDY DESIGN, SIZE, DURATION Multicenter population-based retrospective cohort study involving 9073 patients treated in three fertility clinics in Brazil, Turkey and Vietnam between 2015 and 2017. PARTICIPANTS/MATERIALS, SETTING, METHODS Participants were women with infertility between 22 and 42 years old in their first IVF/ICSI cycle of standard ovarian stimulation whose fresh and/or frozen embryos were transferred until delivery of a live born or until all embryos were used. Patients were retrospectively classified according to the POSEIDON criteria into four groups based on female age, antral follicle count (AFC), and the number of oocytes retrieved or into a control group of normal responders (non-POSEIDON). POSEIDON patients encompassed younger (<35 years) and older (35 years or above) women with an AFC ≥5 and an unexpected poor (<4 retrieved oocytes) or suboptimal (4–9 retrieved oocytes) response to stimulation, and respective younger and older counterparts with an impaired ovarian reserve (i.e. expected poor responders; AFC <5). Non-POSEIDON patients were those with AFC ≥5 and >9 oocytes retrieved. CDR was computed per one aspirated cycle. Logistic regression analysis was carried out to examine the association between patient classification and CDR. MAIN RESULTS AND ROLE OF CHANCE The CDR was lower in the POSEIDON patients than in the non-POSEIDON patients (33.7% vs 50.6%; P < 0.001) and differed across POSEIDON groups (younger unexpected poor responder [Group 1a; n = 212]: 27.8%, younger unexpected suboptimal responder [Group 1b; n = 1785]: 47.8%, older unexpected poor responder [Group 2a; n = 293]: 14.0%, older unexpected suboptimal responder [Group 2b; n = 1275]: 30.5%, younger expected poor responder [Group 3; n = 245]: 29.4%, and older expected poor responder [Group 4; n = 623]: 12.5%. Among unexpected suboptimal/poor responders (POSEIDON Groups 1 and 2), the CDR was twice as high in suboptimal responders (4–9 oocytes retrieved) as in poor responders (<4 oocytes) (P = 0.0004). Logistic regression analysis revealed that the POSEIDON grouping, number of embryos obtained, number of ET cycles per patient, number of oocytes collected, female age, duration of infertility and BMI were relevant predictors for CDR (P < 0.001). LIMITATIONS, REASONS FOR CAUTION Our study relied on the antral follicle count as the biomarker used for patient classification. Ovarian stimulation protocols varied across study centers, potentially affecting patient classification. WIDER IMPLICATIONS OF THE FINDINGS POSEIDON patients exhibit lower CDR per aspirated IVF/ICSI cycle than normal responders; the differences are mainly determined by female age and number of oocytes retrieved, thereby reflecting the importance of oocyte quality and quantity. Our data substantiate the validity of the POSEIDON criteria in identifying relevant subpopulations of patients with low-prognosis in IVF/ICSI treatment. Efforts in terms of early diagnosis, prevention, and identification of specific interventions that might benefit POSEIDON patients are warranted. STUDY FUNDING/COMPETING INTEREST(S) Unrestricted investigator-sponsored study grant (MS200059_0013) from Merck KGaA, Darmstadt, Germany. The funder had no role in study design, data collection, analysis, decision to publish or manuscript preparation. S.C.E. declares receipt of unrestricted research grants from Merck and lecture fees from Merck and Med.E.A. H.Y. declares receipt of payment for lectures from Merck and Ferring. L.N.V. receives speaker fees and conferences from Merck, Merck Sharp and Dohme (MSD) and Ferring and research grants from MSD and Ferring. J.F.C. declares receipt of statistical services fees from ANDROFERT Clinic. T.M.H. received speaker fees and conferences from Merck, MSD and Ferring. P.H. declares receipt of unrestricted research grants from Merck, Ferring, Gedeon Richter and IBSA and lecture fees from Merck, Gedeon Richter and Med.E.A. C.A. declares receipt of unrestricted research grants from Merck and lecture fees from Merck. The remaining authors have no conflicts of interest to disclose. TRIAL REGISTRATION NUMBER N/A.

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Section: Introductionmentioning

confidence: 99%

Cumulative delivery rate per aspiration IVF/ICSI cycle in POSEIDON patients: a real-world evidence study of 9073 patients

Esteves¹,

Yaralı́

Vuong

et al. 2021

Human Reproduction

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“…Groups 1 and 2 comprise patients with unexpected POR due to abnormal ovarian Gn response, while groups 3 and 4 comprise POR patients with a low ovarian reserve. It is better to select individualized ovulation induction regimens for different types of POR patients (8).…”

Section: With the Rapid Socioeconomic Development And Thementioning

confidence: 99%

Efficacy of progestin-primed ovarian stimulation (PPOS) versus minimal stimulation in women of advanced maternal age with poor ovarian response under the Patient-Oriented Strategies Encompassing Individualized Oocyte Number (POSEIDON) criteria

Zhao

Wang

2023

Ann Palliat Med

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Background: We investigated the efficacy of progestin-primed ovarian stimulation (PPOS) and minimal stimulation using clomiphene citrate (CC) + gonadotropin (Gn) for in-vitro fertilization-embryo transfer (IVF-ET) in advanced maternal age (AMA) women with poor ovarian response (POR) according to the Patient-Oriented Strategies Encompassing Individualized Oocyte Number (POSEIDON) criteria.Methods: A retrospective analysis was performed using the data of AMA patients who had received IVF-ET due to a low ovarian reserve. The enrolled patients were screened according to the POSEIDON group 4 criteria. 102 patients were included in the study, including 52 in the PPOS group and 50 in the minimal stimulation group (who received CC + Gn). The duration of Gn administration, Gn dose, estradiol (E2), and luteinizing hormone (LH) levels on the day of trigger, the cancellation rate of the oocyte retrieval cycle, the number of oocytes retrieved, the number of metaphase II (MII) oocytes, and IVF laboratory outcomes during ovarian stimulation were compared between the 2 groups.Results: No significant differences were found in terms of age, infertility, body mass index (BMI), and basal follicle-stimulating hormone, LH, E2, AFC, and AMH between the 2 groups (all P>0.05). The duration of ovarian stimulation [(9.43±2.44) vs. (7.48±3.09) days, P<0.05] was significantly longer and the total Gn dose [(2,423.22±738.66) vs. (1,579.68±728.86) IU, P<0.05] were significantly higher in the PPOS group than the minimal stimulation group. The LH value on the day of trigger in the PPOS group (3.28 mIU/mL) was significantly lower than that in the minimal stimulation group (5.57 mIU/mL) (P<0.05). The number of oocytes retrieved, normal fertilization rate, number of good-quality embryos on day 3, number of transferable embryos, and number of frozen blastocysts did not differ significantly between the 2 groups (all P>0.05). The proportion of MII oocytes was significantly higher in the PPOS group than the minimal stimulation group (94.05% vs. 81.40%, P<0.05).Conclusions: For patients in the POSEIDON group 4, PPOS effectively blocked the premature LH surge and increased the proportion of mature oocytes. Thus, it is a feasible ovulation stimulation protocol for AMA women with POR.

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“…Nonetheless, the quality of association studies in Reproductive Genetics should take into account selection bias, different treatments and differential follow-ups among IVF centers. In addition, the use of check-list proposed STROBE or GRACE guidelines should be encouraged to increase the overall quality of published articles (21,83,84).…”

Section: Future Researchmentioning

confidence: 99%

“…For instance, a subgroup of women with normal ovarian reserve but suboptimal or poor response (hyporesponders) have been described (17)(18)(19). These patients have an "unexpected" reduced response to ovarian stimulation and are characterized by low prognosis to ART (17,20,21). The mechanisms underlying this unexpected ovarian resistance to ovarian stimulation are not fully understood, but it is believed that an individual's genetics play a significant role (17,22).…”

Section: Introductionmentioning

confidence: 99%

Effect of Genetic Variants of Gonadotropins and Their Receptors on Ovarian Stimulation Outcomes: A Delphi Consensus

et al. 2022

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BackgroundA Delphi consensus was conducted to evaluate the influence of single nucleotide polymorphisms (SNPs) in genes encoding gonadotropin and gonadotropin receptors on clinical ovarian stimulation outcomes following assisted reproductive technology (ART) treatment.MethodsNine experts plus two Scientific Coordinators discussed and amended statements plus supporting references proposed by the Scientific Coordinators. The statements were distributed via an online survey to 36 experts, who voted on their level of agreement or disagreement with each statement. Consensus was reached if the proportion of participants agreeing or disagreeing with a statement was >66%.ResultsEleven statements were developed, of which two statements were merged. Overall, eight statements achieved consensus and two statements did not achieve consensus. The statements reaching consensus are summarized here. (1) SNP in the follicle stimulating hormone receptor (FSHR), rs6166 (c.2039A>G, p.Asn680Ser) (N=5 statements): Ser/Ser carriers have higher basal FSH levels than Asn/Asn carriers. Ser/Ser carriers require higher amounts of gonadotropin during ovarian stimulation than Asn/Asn carriers. Ser/Ser carriers produce fewer oocytes during ovarian stimulation than Asn/Asn or Asn/Ser carriers. There is mixed evidence supporting an association between this variant and ovarian hyperstimulation syndrome. (2) SNP of FSHR, rs6165 (c.919G>A, p.Thr307Ala) (N=1 statement): Few studies suggest Thr/Thr carriers require a shorter duration of gonadotropin stimulation than Thr/Ala or Ala/Ala carriers. (3) SNP of FSHR, rs1394205 (−29G>A) (N=1 statement): Limited data in specific ethnic groups suggest that A/A allele carriers may require higher amounts of gonadotropin during ovarian stimulation and produce fewer oocytes than G/G carriers. (4) SNP of FSH β-chain (FSHB), rs10835638 (−211G>T) (N=1 statement): There is contradictory evidence supporting an association between this variant and basal FSH levels or oocyte number. (5) SNPs of luteinizing hormone β-chain (LHB) and LH/choriogonadotropin receptor (LHCGR) genes (N=1 statement): these may influence ovarian stimulation outcomes and could represent potential future targets for pharmacogenomic research in ART, although data are still very limited.ConclusionsThis Delphi consensus provides clinical perspectives from a diverse international group of experts. The consensus supports a link between some variants in gonadotropin/gonadotropin receptor genes and ovarian stimulation outcomes; however, further research is needed to clarify these findings.

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Improving Reporting of Clinical Studies Using the POSEIDON Criteria: POSORT Guidelines

Cited by 19 publications

References 84 publications

Cumulative delivery rate per aspiration IVF/ICSI cycle in POSEIDON patients: a real-world evidence study of 9073 patients

Cumulative delivery rate per aspiration IVF/ICSI cycle in POSEIDON patients: a real-world evidence study of 9073 patients

Efficacy of progestin-primed ovarian stimulation (PPOS) versus minimal stimulation in women of advanced maternal age with poor ovarian response under the Patient-Oriented Strategies Encompassing Individualized Oocyte Number (POSEIDON) criteria

Effect of Genetic Variants of Gonadotropins and Their Receptors on Ovarian Stimulation Outcomes: A Delphi Consensus

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