Abstract: Introduction: The 2024 Australian evidence-based guideline for unexplained infertility provides clinicians with evidence-based recommendations for the optimal diagnostic workup for infertile couples to establish the diagnosis of unexplained infertility and optimal therapeutic approach to treat couples diagnosed with unexplained infertility in the Australian health care setting. The guideline recommendations were adapted for the Australian context from the rigorous, comprehensive European Society of Human Reproduction and Embryology (ESHRE) 2023 Evidence-based guideline: unexplained infertility, using the ADAPTE process and have been approved by the Australian National Health and Medical Research Council.
Main Recommendations: The guideline includes 40 evidence-based recommendations, 21 practice points and three research recommendations addressing: definition - defining infertility and frequency of intercourse, infertility and age, female and male factor infertility; diagnosis - ovulation, ovarian reserve, tubal factor, uterine factor, laparoscopy, cervical/vaginal factor, male factor, additional testing for systemic conditions; and treatment - expectant management, active treatment, mechanical-surgical procedures, alternative therapeutic approaches, quality of life. CHANGES IN ASSESSMENT AND MANAGEMENT RESULTING FROM THE GUIDELINE: This guideline refines the definition of unexplained infertility and addresses basic diagnostic procedures for infertility assessment not considered in previous guidelines on unexplained infertility. For therapeutic approaches, consideration of evidence quality, efficacy, safety and, in the Australian setting, feasibility, acceptability, cost, implementation and ultimately recommendation strength were integrated across multidisciplinary expertise and consumer perspectives in adapting recommendations to the Australian context by using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework, which had not been used in past guidelines on unexplained infertility to formulate recommendations. The Australian process also included an established data integrity check to ensure evidence could be trusted to guide practice. Practice points were added and expanded to consider the Australian setting. No evidence-based recommendations were underpinned by high quality evidence, with most having low or very low quality evidence. In this context, research recommendations were made including those for the Australian context. The full guideline and technical report are publicly available online and can be accessed at https://www.monash.edu/medicine/mchri/infertility and are supported by extensive translation resources, including the free patient ASKFertility mobile application (https://www.askfertility.org/).
(© 2024 The Author(s). Medical Journal of Australia published by John Wiley & Sons Australia, Ltd on behalf of AMPCo Pty Ltd.)
References: Practice Committee of the American Society for Reproductive Medicine. Evidence‐based treatments for couples with unexplained infertility: a guideline. Fertil Steril 2020; 113: 305‐322.
Zegers‐Hochschild F, Adamson GD, Dyer S, et al. The international glossary on infertility and fertility care, 2017. Fertil Steril 2017; 108: 393‐406.
Buckett W, Sierra S. The management of unexplained infertility: an evidence‐based guideline from the Canadian Fertility and Andrology Society. Reprod Biomed Online 2019; 39: 633‐640.
National Health and Medical Research Council. NHMRC levels of evidence and grades for recommendations for developers of guidelines. Canberra: NHMRC, 2009. https://www.mja.com.au/sites/default/files/NHMRC.levels.of.evidence.2008‐09.pdf (viewed June 2024).
Costello MF, Teede H, Farquhar C, et al. Australian evidence‐based guideline for unexplained infertility: ADAPTE process from the ESHRE evidence‐based guideline on unexplained infertility 2024 [website]. Melbourne: Monash University, 2024. https://bridges.monash.edu/articles/online_resource/Australian_evidence‐based_guideline_for_unexplained_infertility_ADAPTE_process_from_the_ESHRE_evidence‐based_guideline_on_unexplained_infertility_2024_/26061295 (viewed June 2024).
Guideline Group on Unexplained Infertility; Romualdi D, Ata B, Bhattacharya S, et al. Evidence‐based guideline: unexplained infertility. European Society of Human Reproduction and Embryology, 2023. https://www.eshre.eu/guideline/UI (viewed Aug 2024).
Guideline Group on Unexplained Infertility; Romualdi D, Ata B, Bhattacharya S, et al. Evidence‐based guideline: unexplained infertility†. Hum Reprod 2023; 38: 1881‐1890.
ADAPTE Collaboration (2009). The ADAPTE Process: resource toolkit for guideline adaptation; version 2.0. Guideline International Network, 2010. https://g‐i‐n.net/wp‐content/uploads/2021/05/ADAPTE‐Resource‐toolkit‐V2.1‐March‐2010‐updated‐disclaimer.pdf](viewed Aug 2024).
Mousa A, Le Clef N, Costello M, et al. Technical report for the Australian Adaptation of the ESHRE Evidence‐based guideline for unexplained infertility 2024. Melbourne: Monash University, 2024. https://bridges.monash.edu/articles/report/Technical_Report_for_the_Australian_Adaptation_of_the_ESHRE_Evidence‐based_guideline_for_unexplained_infertility_2024_/26299363 (viewed June 2024).
Brouwers MC, Kho ME, Browman GP, et al. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ 2010; 182: E839‐E842.
Higgins J, Thomas J, Chandler J, et al; editors. Cochrane handbook for systematic reviews of interventions version 6.4 [updated Aug 2023]. Cochrane, 2023. https://training.cochrane.org/handbook/current (viewed Aug 2024).
Mousa A, Flanagan M, Tay CT, et al. Research Integrity in Guidelines and evIDence synthesis (RIGID): a framework for assessing research integrity in guideline development and evidence synthesis. Lancet eClinicalMedicine 2024; https://doi.org/10.1016/j.eclinm.2024.102717.
Mol BW, Lai S, Rahim A, et al. Checklist to assess Trustworthiness in RAndomised Controlled Trials (TRACT checklist): concept proposal and pilot. Res Integr Peer Rev 2023; 8: 6.
Lazzari E, Baffour B, Chambers GM. Residential proximity to a fertility clinic is independently associated with likelihood of women having ART and IUI treatment. Hum Reprod 2022; 37: 2662‐2671.
Gilbert E, Walker R, Simon D, et al. “We are only looking at the tip of the iceberg in infertility”: perspectives of health providers about fertility issues and management among Aboriginal and Torres Strait Islander people. BMC Health Serv Res 2021; 21: 704.
Clarke M, Whitson N, Williams C, Robson SJ. A silent burden‐prolapse, incontinence, and infertility in Australian Aboriginal and Torres Strait Islander women: a systematic search and narrative review. Int J Gynaecol Obstet 2021; 155: 268‐274.
Keller E, Botha W, Chambers GM. What features of fertility treatment do patients value? Price elasticity and willingness‐to‐pay values from a discrete choice experiment. Appl Health Econ Health Policy 2023; 21: 91‐107.
World Health Organization. WHO laboratory manual for the examination and processing of human semen. Geneva: WHO, 2021. https://www.who.int/publications/i/item/9789240030787 (viewed Aug 2024).
Goth C, Godehardt D, Godehardt E, et al. Time to pregnancy: results of the German prospective study and impact on the management of infertility. Hum Reprod 2003; 18: 1959‐1966.
Björndahl L, Kirkman Brown J; Editorial Board Members of the WHO Laboratory Manual for the Examination and Processing of Human Semen. The sixth edition of the WHO Laboratory Manual for the Examination and Processing of Human Semen: ensuring quality and standardization in basic examination of human ejaculates. Fert Steril 2022; 117: 246‐251.
Wessel JA, Mochtar MH, Besselink DE, et al. Expectant management versus IUI in unexplained subfertility and a poor pregnancy prognosis (EXIUI study): a randomized controlled trial. Hum Reprod 2022; 37: 2808‐2816.
Lai S, Wang R, van Wely M, et al. IVF versus IUI with ovarian stimulation for unexplained infertility: a collaborative individual participant data meta‐analysis. Hum Reprod Update 2024; 30: 174‐185.
Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci 2022; 17: 75.
Au LS, Feng Q, Shingshetty L, et al. Evaluating prognosis in unexplained infertility. Fertil Steril 2024; 121(5): 717‐729.
Norman RJ. Prophecy, prediction, and prognosis — can we improve the advice we give on the chance of pregnancy and treatment options for infertility? Fertil Steril 2024; 121: 715‐716.
Bensdorp AJ, van der Steeg JW, Steures P, et al. A revised prediction model for natural conception. Reprod Biomed Online 2017; 34: 619‐626.
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