STUDY TITLE: Evaluation of Diamine Oxidase (DAO) Deficiency in Infertile Women.


PROMOTER: DR Healthcare S.L.U.



We are reaching out to you to provide information about a research study in which you are invited to participate. The study has been approved by a Research Ethics Committee in accordance with current legislation, the Biomedical Research Law 14/2007.

Our intention is solely to ensure that you receive accurate and sufficient information to assess whether you wish to participate in this study or not. Please read this information paper carefully, and we will address any questions you may have afterwards. Additionally, you are free to consult with individuals you deem appropriate.


You should be aware that your participation in this study is voluntary, and you may decide not to participate or change your decision and withdraw your consent at any time without affecting your relationship with your physician or causing any problem to your treatment.


The enzyme DAO (Diamine Oxidase) regulates histamine levels in the body. Having a DAO deficiency results in increased histamine levels. This deficiency affects the menstrual cycles in healthy women and plays a significant role in pregnancy. As of today, it has not been investigated whether women with histamine intolerance, low DAO activity, or genetic DAO deficiency before becoming pregnant could be associated with having difficulty conceiving, experiencing complicated pregnancies, or facing a higher risk of miscarriage.

Therefore, you are invited to participate in a study with the objective of estimating the prevalence of DAO deficiency in infertile women attending fertility clinics.

This clinical study will include 150 women with fertility issues who visit the fertility center.

The study consists of a single consultation where sociodemographic data will be collected, and an oral saliva sample will be taken for the analysis of DAO deficiency markers. This sample can be stored for up to a year in case a new analysis is needed and will then be destroyed. The preservation of the sample is VOLUNTARY.

In the future, your physician may contact you again to offer the opportunity to participate in new studies on DAO deficiency. Permission for contact and the sharing of contact information is VOLUNTARY


The data collected through your participation may generate new insights into the influence of DAO deficiency on infertility. Furthermore, having this result can potentially be beneficial in the case of genetic DAO deficiency, as enzyme DAO supplementation is available.

No risks of any kind have been observed due to the tests conducted because of the study.


The study promoter holds an insurance policy that complies with current legislation and will provide compensation and indemnification in the event of harm to your health or injuries that may occur regarding your participation in the study.


The processing, communication, and sharing of personal data of all participants will comply with Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016, concerning the protection of natural persons regarding the processing of personal data, and the free movement of such data, which is mandatory as of May 25, 2018. The legal basis justifying the processing of your data is the consent you give at this moment, as stipulated in Article 9 of Regulation (EU) 2016/679

The data collected for these studies will be identified only by a code, so no information that could identify participants will be included. Only the study’s medical staff and their collaborators with specific permission will be able to link your data collected in the study to your medical history.

Your identity will not be accessible to anyone else except in the case of a medical emergency or legal requirement. Your personally identifiable information may be accessed by health authorities, the Research Ethics Committee, and staff authorized by the study promoter when necessary to verify data and study procedures, while always maintaining confidentiality in accordance with current legislation.

Only encoded data, which in no case will contain information that can directly identify the participant (such as name, initials, address, social security number, etc.), will be shared with third parties and other countries. In the event of such sharing, it will be for the same purpose as described in the study and confidentiality will be assured.

If there is a transfer of encoded data outside the EU, whether to entities related to the hospital where you are participating, service providers, or researchers collaborating with your physician, your data will be protected by safeguards such as contracts or other mechanisms established by data protection authorities.

In addition to the rights already provided for in previous legislation (access, modification, opposition, and cancellation of data, which is now referred to as “erasure” in the new Regulation), you can now also limit the processing of incorrect data, request a copy of the data, or request that the data you have provided for the study be transferred to a third party (data portability). To exercise these rights or if you wish to learn more about confidentiality, you should contact the main researcher of the study or the Data Protection Officer of Institut Marquès at You also have the right to contact the Data Protection Agency in case you are not satisfied.

Data that has already been collected cannot be deleted even if you decide to leave the study to ensure the validity of the research and comply with legal obligations and drug authorization requirements. However, no new data will be collected if you choose to stop participating.

The Researcher and the Promoter are obliged to retain the data collected for the study for at least 10 years after its completion. Subsequently, personal information will only be retained by the healthcare center for your health care and by the promoter for other scientific research purposes if the patient has given consent for this and if it is permitted by law and applicable ethical requirements.


The study promoter is responsible for managing the funding of the study. To conduct the study, the promoter has signed a contract with the center where it will be conducted and with the study’s physician.


Participation in this study involves obtaining oral mucosal samples during the study visit. In accordance with the provisions of Law 14/2007 on biomedical research and Royal Decree 1716/2011, which regulates the use of biological samples in research, by signing this document, you agree that the samples obtained will be used for the purposes of this study

The samples will be analyzed, and any remaining samples will be stored at Echevarne Laboratories. Once the study is completed, any remaining samples will be destroyed unless you sign a specific consent for them to be stored and used in future research

A code will be used to identify your sample and no data that could reveal your identity will be used. Only the study’s physician and their collaborators will be able to link the sample to you.

Data derived from the use of these samples will be treated in the same way as other data obtained during this study.

The donation of biological samples for this study is free and voluntary. This means that you will not have any rights to potential commercial benefits from discoveries that may result from biomedical research.

If any relevant information that could affect your health or that of your family members is obtained, you will be notified. In case it is necessary to contact you, the data in your medical history will be used. However, your right to decide not to receive this information will be respected and you can indicate your preference by ticking such option on the consent form.


Any new information regarding the treatment used in the study that may affect your willingness to participate, discovered during your participation, will be communicated to you by your physician as soon as possible.

If you decide to withdraw your consent to participate in this study, no new data will be added to the database, and you may request the destruction of all previously retained identifiable samples to prevent further analysis.

You should also be aware that you may be excluded from the study if the study promoter or researchers deem it necessary, either for safety reasons, due to any adverse events resulting from the study medication, or because they believe you are not complying with established procedures. In any case, you will receive a proper explanation of the reason for your withdrawal from the study.

By signing the attached consent form, you commit to complying with the study procedures that have been explained to you.

Upon completion of your participation, you will receive the best available treatment that your physician deems most suitable for your condition.