Confidentiality and data protection

The study doctor and his/her staff will use care to keep your name and other personal information that identifies you confidential. The study doctor or study staff will assign a randomly selected identification number to each man enrolled into the study. During and after the study, you will be identified only by this identification number. Your, your partner’s and your baby’s study records will, therefore, be “coded”. A list linking the name and other personal information of each man enrolled into the study with the randomly selected identification number (the “code-list”) will be kept for at least 25 years to make it possible to link your study records back to you in the future. The coded study records may be kept for longer than 25 years if doing so is required by law. It may not be possible to delete the coded study records before the end of these time periods. After the time for keeping the records ends, the records will be destroyed. Your coded study records will be used and shared only for purposes of

• Conducting the research as described in this informed consent form;
• Complying with applicable laws;
• Including (non-personally identifiable) information in study-related scientific publications;
• Monitoring the study for safety and verification reasons, including retaining study data in accordance with laws and regulations;
• Developing, marketing, and labelling of the sponsor’s product being tested in this study; and
• Conducting future research in the area of infertility or pursuing exploratory purposes compatible with the purposes of this study.

Your coded study records will be shared with the sponsor and its existing or future affiliates, research partners and authorised representatives of the sponsor, study monitors, members of Ethics Committees /Institutional Review Boards and regulatory authorities. Furthermore, to the extent necessary for the sponsor’s compliance with regulatory obligations and solely for the purpose of verifying the collected study data, your medical records will be made available to authorised representatives of the sponsor and study monitors and may also be made available to members of Ethics Committees /Institutional Review Boards and regulatory authorities. Some of those whom your information is shared with may be located in countries outside of Europe (in particular, the European Economic Area or “EEA”). The privacy and data protection laws in countries outside the EEA may not protect personal information in the same way as the laws in your own country. If your information is transferred to a country outside of the EEA, Ferring will make sure that there are sufficient security measures in place so that your information is protected as well as it is in your own country. For instance, by written agreements, and by data encryption and protection with a password that is shared via a separate channel before the data are transferred over the internet or via another electronic media.

You have the right to withdraw your consent to participate in this study at any time. In that case, however, all data and information collected about you in the study before the time of your withdrawal will remain part of the study data base, may not be removed, and can still be used by the sponsor as provided in this informed consent form.

You have certain rights in respect of your personal information. In particular, you have a right to withdraw your consent to the collection, use and disclosure of your information. In this case, no new information about you will be collected for purposes of this study. However, the information that was already collected will continue to be used in order to ensure the integrity of the study records as required by law. If you withdraw your consent to the collection, use and disclosure of your data, you will not be able to continue participating in this study, but this will not involve any penalty or loss of benefit to which you are otherwise entitled. You also have a right to access, rectification and deletion of your personal information, subject to limitations provided for in law. You understand that for this study, your right to access will be postponed in so far as necessary to preserve the integrity of the study, for example, to protect the blinded nature of the study. If you do not accept this, you may not be able to participate in the study.

If you wish to withdraw your consent or exercise your rights, please contact your study doctor. If you are concerned about the collection and use of your personal information, you can contact the authority responsible for privacy and data protection in the country where you live. Also, Ferring has a Data Protection Officer, who can be contacted at: https://ferring.ethicspoint.eu/custom/ferring/forms/data/form_data.asp.

A description of this study will be publicly available on http://www.ClinicalTrials.gov, a U.S. website used by the sponsor and www.clinicaltrialsregister.eu which is the EU Clinical Trials Register. None of these websites will include information that can identify you. At most, at the end of the study, the websites will include a summary of the general study results. You can search these websites at any time. Study registration may also occur in other registries in accordance with local regulatory requirements. A summary of the study results is made publicly available in accordance with applicable regulatory requirements