Developing a core outcome set for future infertility research: an international consensus development study

Study Question

Can a core outcome set to standardize outcome selection, collection, and reporting across future infertility research be developed?

Summary Answer

A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCT) and systematic reviews evaluating potential treatments for infertility.

What is Known Already

Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions, and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret.

Study Design, Size, Duration

A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries).

Participants/Materials, Setting, Methods

Healthcare professionals, researchers, and people with fertility problems were brought together in an open and transparent process using formal consensus science methods.

Main Results and the Role of Chance

The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin, and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth, and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable.

Limitations, Reasons for Caution

We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition, and an arbitrary consensus threshold.

Wider Implications of the Findings

Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection, and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Ferility and Sterility, and Human Reproduction, have committed to implementing this core outcome set.