Australia Issues New Guidelines for Unexplained Infertility

Monash University

A new Guideline for health professionals treating people affected by unexplained infertility aims to enable them to better inform patients and increase the chances of pregnancy.

Led by experts at the University of Adelaide, UNSW Sydney and Monash University, the evidence-based Australian Guideline has been published in the Medical Journal of Australia alongside the launch of consumer resources including a new Monash Ask Fertility App*.

Up to 30 per cent of infertile heterosexual couples are affected by 'unexplained' infertility, which cannot be assigned a direct cause.

The diagnosis is made when no abnormalities of the female or male reproductive systems are clearly identified, mostly by excluding possible causes such as the absence of ovulation or low sperm count.

The Centre for Research Excellence in Women's Health in Reproductive Life (CRE WHiRL), which is administered by Monash University, partnered with the European Society of Human Reproduction and Embryology (ESHRE) in developing the international Guidelines, then engaged Australian experts and consumers to adapt these for use in Australia.

CRE WHiRL is funded by the Australian National Health and Medical Research Council (NHMRC). The adapted Guideline is approved by NHMRC and endorsed by The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the Fertility Society of Australia and New Zealand (FSANZ).

The Australian Evidence-based Guideline for unexplained infertility advances our understanding of infertility prognosis and treatment and has new evidence-based recommendations so that women and their partners can make informed decisions and avoid expensive, often ineffective, or unproven treatments.

Consumers, including Indigenous and women from culturally and linguistically diverse (CALD) backgrounds, have been engaged in guideline development and translation.

CRE WHiRL is led by Monash University's Professor Helena Teede, who joined University of Adelaide Professor Robert Norman and UNSW Sydney's Dr Michael Costello as the experts leading the Guideline.

Professor Teede said the Guideline was developed using the most robust processes, involved all stakeholders including those with lived experience of infertility, and was approved by the NHMRC, so the community could be reassured it was trustworthy.

"Unexplained infertility greatly impacts quality of life, and it is important to ensure those affected receive the best advice and care for optimal outcomes, whilst avoiding rapidly rising use of often unproven treatments, increasing costs and inequity seen in Australia for those with unexplained infertility," Professor Teede said.

Professor Norman added: "This new guideline will help to streamline and simplify treatments, potentially reducing cost and increasing equity, by avoiding complex testing and treatments that were not necessarily evidence-based. The Guideline's evidence-based advice will play an important role in improving health outcomes for those with unexplained infertility and is adapted for the Australian health system and context."

Infertility is defined as the inability to achieve pregnancy after 12 months of regular unprotected intercourse and affects around 15 per cent of couples. It is increasing due to ecosocial factors including advancing maternal age and rising weight, both of which adversely affect fertility.

"This year, IVF is estimated to cost the government $500 million through Medicare, with another $200 million at a cost for consumers in out-of-pocket expenses. If fully implemented, this Guideline could potentially save more than $100 million in unnecessary health procedure costs annually, while maintaining current pregnancy chances and widening access to treatment," Professor Norman said.

Dr Costello said until now, this had been compounded by a lack of evidence-based guidelines and limited independent consumer information and empowerment strategies. "The ESHRE and Australian Guideline uses the best available scientific evidence to guide health professionals in diagnosing and treating those with unexplained infertility," he said.

The Guideline outlines the definition of unexplained infertility, diagnostic tests, treatments and differences between explained and unexplained infertility.

It is aimed at but not limited to general practitioners, gynaecologists, andrologists, infertility specialists, reproductive surgeons and those with unexplained infertility.

"The Guideline aims to assist healthcare professionals and couples in appropriate and effective management of the condition, acknowledging that each medical decision must consider individual characteristics, preferences, socioeconomic status, beliefs and values," Dr Costello said.

"It should also be acknowledged that couples with unexplained infertility may experience considerable impact on their quality of life and they can be offered support and therapeutic counselling."

Professor Norman and Dr Costello are presenting an outline of the Guideline, for the first time, to the FSANZ Society on Tuesday, 17 September in Perth.

*Ask Fertility helps women with infertility find information of the highest quality from leading experts and includes self-care and shared decision-making tools: www.askfertility.org

About the unexplained fertility Guideline

The Australian Evidence-based Guideline for Unexplained Infertility: Adapted from the ESHRE Evidence-based Guideline for Unexplained Infertility was developed in response to a priority from the State and Federal Governments with growing concern about evidence-based practice in the fertility industry, and an increasing cost to government and consumers.

Administered by Monash University's Monash Centre for Health Research and Implementation (MCHRI), the NHMRC Centre for Research Excellence in Women's Reproductive Life (CRE-WHiRL) coordinated the project with national and international collaborators. In 2023, with 39 societies and more than 100 multidisciplinary and lived-experience experts, CRE-WHiRL also released the International Evidence-based Guideline for the assessment and management of polycystic ovary syndrome 2023. The PCOS Guideline is used in 195 countries, won the Engagement Australia 2023 International Excellence Award and scaled up the Ask PCOS App, which has more than 70,000 users globally.

Professor Teede is part of the Monash Women's Health Alliance (MWHA) , which channels and leverages our network of over 185 research leaders, over 50 specialist research groups, data sets, registries, biobanks and clinical trial footprint, to lead a step change in prevention, public health and clinical practice, for women, girls and gender diverse people of all ages.

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