This guideline document was generated using a systematic review and meta-analysis of the relevant literature, followed by evidence grading.
1. Registration, reporting, and patient and public involvement
Following the preregistration of the entire project on creating Egyptian IVF laboratory guidelines with the Centre for Open Science (https://doi.org/10.17605/OSF.IO/23KBU) on 21 February 2024, we proceeded to implement the appropriate methodology for studying the impact of AOA on reproductive outcomes as outlined in the guidelines. We documented the findings in accordance with the prescribed protocols. We did not involve patients or the public in any aspect of the design or implementation of this review.
2. Literature search strategy and selection
We formulated an all-encompassing search plan for the pertinent databases: Cochrane Library, PubMed, and Scopus. The search encompassed keywords and different forms of terms associated with 'AOA', 'sperm abnormalities', 'assisted reproduction', 'IVM oocytes', 'ART', 'in vitro fertilisation', 'Intracytoplasmic sperm injection', 'testicular sperm', 'fertilisation failure', 'embryo development', 'pregnancy outcomes', 'embryo implantation', 'live birth', 'neonatal outcomes', and 'birth defects'. We systematically searched for studies examining the correlation between AOA and outcomes of assisted reproduction. Our search was limited to studies conducted in English and involving human subjects. We conducted a comprehensive examination of the references cited in the selected reviews. We conducted a literature search until the date of March 1, 2024. Information regarding the literature search, reviewers, and other relevant details will be documented in separate publications that undergo peer review. The reviewers convened a meeting to establish a standardised selection strategy. Once the eligible citations were identified as duplicates, the full texts were thoroughly examined, and relevant data was extracted.
3. Synthesis of the evidence
We exclusively incorporated primary studies
that contained quantitative data. We employed a random-effects model to
calculate the magnitude of the association using the odds ratio (OR) across all
studies. We utilised the Hartung–Knapp–Sidik–Jonkman method, which is regarded
as superior when heterogeneity exists [14].
We classified the evidence using the GRADE (http://www.gradeworkingroup.org)
framework, along with a more extensive set of criteria that had been previously
published [15, 16]. The WHO Handbook for Guidelines employs the
GRADE (Grading of Recommendations, Assessment, Development and Evaluation)
approach to evaluate the quality of evidence, create recommendations, and
present them [17]. The World Health Organisation (WHO) utilises
GRADE methods due to their status as globally recognised standards for
generating clear and consensus-based recommendations. Comprehensive information
regarding GRADE can be found on the following websites:
■ GRADE working group: http://www.gradeworkingroup.org
■ GRADE online training modules: http://cebgrade.mcmaster.ca/
■ GRADE profile software: http://ims.cochrane.org/revman/gradepro
Table 1 Quality of Evidence in GRADE
Quality level |
Definition |
High |
We are very confident that the true effect lies close to that of the estimate of the effect.
|
Moderate |
We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
|
Low |
Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
|
Very low |
We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. |
GRADE: Grading of Recommendations Assessment, Development and Evaluation. |
Table 2 Significance of the four levels of evidence
Quality |
Definition
|
Implications
|
High |
The guideline development group is very confident that the true effect lies close to that of the estimate of the effect |
Further research is very unlikely to change confidence in the estimate of effect |
Moderate
|
The guideline development group is moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different |
Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate |
Low
|
Confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the true effect |
Further research is very likely to have an important impact on confidence in the estimate of effect and is unlikely to change the estimate |
Very low
|
The group has very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of the effect |
Any estimate of effect is very uncertain |