Identifying essential information for a valid informed consent of egg donors: an international Delphi study

What information does an international group of professionals and egg donors consider relevant and morally necessary for prospective egg donors to provide valid informed consent?

Participants considered 80% of all concrete information items (CIIs) to be relevant (e.g. all legal aspects) and 67% to be morally necessary.

Studies indicate that egg donors are not always adequately informed and have expressed a desire for more comprehensive information. This highlights the need for a comprehensive guideline of essential information for prospective egg donors.

This modified Delphi study used a survey in an iterative process of three rounds to reach a consensus on what information items are relevant and morally necessary for a valid informed consent of candidate egg donors. Invitations to participate were sent out in November 2023 and the final round closed in November 2024.

The 35 participants were experienced egg donors and professionals from a range of disciplines (social and medical sciences, bioethics, psychology, fertility medicine and law) from 14 countries. The survey consisted of 13 categories and 133 CIIs, which participants scored for relevance via a 4-point Likert scale and moral necessity on a dichotomous scale (yes/no). Content Validity Index (CVI) was calculated for measuring relevance and percentage of agreement for moral necessity. A comment section was available.

Consensus was indicated as an I-CVI (CVI per item) of 0.78 or higher. The same cut-off was used to indicate consensus for moral necessity. For 27 out of 133 CIIs, the I-CVI was lower than 0.78. The percentage of moral necessity was below 0.78 for 44 CIIs. Four CIIs reached a I-CVI of 1: all experts thought it was relevant for a candidate donor to know (i) the need to undergo ovarian stimulation and (ii) a retrieval procedure, as well as (iii) her legal rights over the donated eggs after the retrieval procedure and (iv) her legal right to withdraw consent. The latter is the only CII that scored 100% on moral necessity. The CII with the lowest I-CVI is 'The family type and characteristics of the potential recipients of the donor eggs' (0.32). The CII with the lowest percentage of agreement for moral necessity was 'An egg donor's social circle might give negative feedback/opinions on the donation' (36.36%). In several categories (e.g. 'Physical side-effects and risks'), almost all CIIs reached a consensus among experienced egg donors, bioethicists, and humanities and social sciences experts, while hardly any CII reached a consensus among fertility experts, lawyers, and academic medical doctors.

Despite our efforts, we were unable to obtain input from registered nurses and midwives. Not all participants remained engaged through all the iterative rounds, which may weaken the results of the study. However, the dropout rates between rounds in this study were within the acceptable 20-30% range.

Our results give fertility professionals a standard of essential information to make sure that prospective egg donors are adequately informed and know what to expect when they decide to donate. It also gives researchers a potential standard to evaluate the quality of the information provision in fertility clinics.

This study is funded by the Special Research Fund, Bijzonder Onderzoeksfonds of Ghent University (BOFSTG2020000901). The authors declare that they have no competing interests.

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