A retrospective evaluation of prognosis and cost-effectiveness of IVF in poor responders according to the Bologna criteria
- PMID: 25432927
- DOI: 10.1093/humrep/deu319
A retrospective evaluation of prognosis and cost-effectiveness of IVF in poor responders according to the Bologna criteria
Abstract
Study question: Do the Bologna criteria for poor responders successfully identify women with poor IVF outcome?
Summary answer: The Bologna criteria effectively identify a population with a uniformly low chance of success.
What is already known: Women undergoing IVF who respond poorly to ovarian hyper-stimulation have a low chance of success. Even if improving IVF outcome in this population represents a main priority, the lack of a unique definition of the condition has hampered research in this area. To overcome this impediment, a recent expert meeting in Bologna proposed a new definition of poor responders ('Bologna criteria'). However, data supporting the relevance of this definition in clinical practice are scanty.
Study design, size, duration: Retrospective study of women undergoing IVF-ICSI between January 2010 and December 2012 in two independent infertility units. Women could be included if they fulfilled the definition of poor ovarian response (POR) according to Bologna criteria prior to initiation of the cycle. Women were included only for one cycle. The main outcome was the live birth rate per started cycle. The perspective of the cost analysis was the one of the health provider.
Participants/materials, setting, methods: Three-hundred sixty-two women from two independent Infertility Units were selected. A binomial distribution model was used to calculate the 95% CI of the rate of success. Characteristics of women who did and did not obtain a live birth were compared. A logistic regression model was used to adjust for confounders. The economic analysis included costs for pharmacological compounds and for the IVF procedure. The benefits were estimated on quality-adjusted life years (QALY). To develop the model, we used the local life-expectancy tables, we applied a 3% discount of life years gained and we used a 0.07 improvement in quality of life associated with parenthood. Sensitivity analyses were performed varying the improvement of the quality of life and including/excluding the male partner. The reference values for cost-effectiveness were the Italian and the local (Lombardy) gross domestic product (GDP) pro capita per year in the studied period and the upper and lower limits suggested by NICE.
Main results and the role of chance: Overall, 23 women had a live birth (6%, 95% CI: 4-9%), in line with the previous evidence. This proportion did not significantly differ in the different subgroups of poor responders. Positive predictive factors of success were previous deliveries (adjusted OR = 3.0, 95% CI: 1.1-8.7, P = 0.039) and previous chemotherapy (adjusted OR = 13.9, 95% CI: 2.5-77.2, P = 0.003). Age, serum AMH, serum FSH and antral follicle count were not significantly associated with live birth. The total cost per live birth was 87 748 Euros, corresponding to 49 919 Euros per QALY. This is above both the limits suggested by NICE for cost-effectiveness and the Italian and local GDP pro capita. Sensitivity analyses mainly support the robustness of the conclusion.
Limitations, reasons for caution: We lack a control group and we cannot thus exclude that an alternative definition of poor responders may be equally if not more valid. Moreover, independent validations are warranted prior to concluding that IVF is not cost-effective. Women should thus not be denied treatment based on our findings. Noteworthy, there is also not yet a consensus on the most appropriate economic model to be used.
Wider implications of the findings: We recommend the use of the Bologna criteria when designing future studies on poor responders. Large multi-centred international studies are now required to draw definite conclusions on the economic profile of IVF in this situation.
Keywords: Bologna criteria; cost-effectiveness; poor responder.
© The Author 2014. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
Similar articles
-
Live birth rates following natural cycle IVF in women with poor ovarian response according to the Bologna criteria.Hum Reprod. 2012 Dec;27(12):3481-6. doi: 10.1093/humrep/des318. Epub 2012 Aug 30. Hum Reprod. 2012. PMID: 22940767
-
Live birth rates after modified natural cycle compared with high-dose FSH stimulation using GnRH antagonists in poor responders.Hum Reprod. 2015 Oct;30(10):2321-30. doi: 10.1093/humrep/dev198. Epub 2015 Aug 25. Hum Reprod. 2015. PMID: 26307091
-
Corifollitropin alfa compared with follitropin beta in poor responders undergoing ICSI: a randomized controlled trial.Hum Reprod. 2015 Feb;30(2):432-40. doi: 10.1093/humrep/deu301. Epub 2014 Dec 9. Hum Reprod. 2015. PMID: 25492411 Clinical Trial.
-
Prognosis and cost-effectiveness of IVF in poor responders according to the Bologna Criteria.Minerva Ginecol. 2018 Feb;70(1):89-98. doi: 10.23736/S0026-4784.17.04132-6. Epub 2017 Sep 12. Minerva Ginecol. 2018. PMID: 28895678 Review.
-
Trends in 'poor responder' research: lessons learned from RCTs in assisted conception.Hum Reprod Update. 2016 Apr;22(3):306-19. doi: 10.1093/humupd/dmw001. Epub 2016 Feb 2. Hum Reprod Update. 2016. PMID: 26843539 Review.
Cited by
-
Update on the management of poor ovarian response in IVF: the shift from Bologna criteria to the Poseidon concept.Ther Adv Reprod Health. 2020 Jul 31;14:2633494120941480. doi: 10.1177/2633494120941480. eCollection 2020 Jan-Dec. Ther Adv Reprod Health. 2020. PMID: 32844159 Free PMC article. Review.
-
Reply: The low responder according to the POSEIDON criteria: is the prognosis really poor?Hum Reprod. 2019 Dec 1;34(12):2557-2558. doi: 10.1093/humrep/dez195. Hum Reprod. 2019. PMID: 31756245 Free PMC article. No abstract available.
-
Double or dual stimulation in poor ovarian responders: where do we stand?Ther Adv Reprod Health. 2021 Jun 30;15:26334941211024172. doi: 10.1177/26334941211024172. eCollection 2021 Jan-Dec. Ther Adv Reprod Health. 2021. PMID: 34263172 Free PMC article. Review.
-
Defining Low Prognosis Patients Undergoing Assisted Reproductive Technology: POSEIDON Criteria-The Why.Front Endocrinol (Lausanne). 2018 Aug 17;9:461. doi: 10.3389/fendo.2018.00461. eCollection 2018. Front Endocrinol (Lausanne). 2018. PMID: 30174650 Free PMC article. Review.
-
The effect of the pooling method on the live birth rate in poor ovarian responders according to the Bologna criteria.Turk J Obstet Gynecol. 2018 Mar;15(1):39-45. doi: 10.4274/tjod.62447. Epub 2018 Mar 29. Turk J Obstet Gynecol. 2018. PMID: 29662715 Free PMC article.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical
Research Materials