Informed Consent form for fertility hormone study

Principal Investigator: Amy Beckley

Organization: MFB Fertility, Inc.

Introduction

Proov tests are fertility tracking tests. They are used for monitoring ovulation at home. These tests measure one or more hormones. These hormones can predict and confirm ovulation. They can also assess when a woman will enter into menopause. Tracking these hormones can help a woman understand if she is ovulating. They can also help identify problems that could be preventing pregnancy.

Purpose of the research

This study is to determine if certain patterns of hormone levels over the cycle are correlated with different pregnancy outcomes.

Duration of Research

Research will be conducted on cycles tracked using the Proov App from March 2020 until April 2023.

Research Procedure

• You will give permission for us to access your testing history collected in the Proov app from March 2020 to April 2023.

• You will complete an online survey about your pregnancy and fertility test results. You will also be asked your age, race, smoking status, and BMI.

Time commitment

• Your test results logged in the Proov app will be shared automatically. Itrequires no additional time from you.

• You will need 10-20 minutes to fill out the fertility survey.

Participant selection

You are being invited because you either used the Proov app and logged at least one complete cycle or were invited by your healthcare provider to participate. We are seeking up to 5,000 volunteers for this study.

Voluntary Participation

Your participation in this research is entirely voluntary. It is your choice whether to participate or not. You may change your mind later and stop even if you agreed earlier.

Funding

The US Department of Defense and MFB Fertility are providing support for this research.

Risks

There is a small risk that a data breach could occur by using the Proov app. You might feel a little discomfort answering survey questions.

Costs

There are no costs to participate in this study.

Benefits

There is no direct benefit to you for enrolling in this study

Reimbursements

You will be emailed a $10 Amazon electronic gift card after enrollment. All gift cards will be sent within 60 day of enrollment.

Confidentiality

All information from this study will be kept confidential. All information will be stored in a secure online database and no one but the researchers will be able to see it. You will use your email address used for your Proov App to fill out the survey responses. You will not submit results with your name. Only the researchers will have access to the data from the Proov app. It will not be shared with or given to anyone except the PI and medical doctors that will review the aggregated study data.

Sharing the Results

You will receive the results of this study via email before it is shared with the public. Private information will not be shared. Study results will be shared via research publications or white papers. Preliminary results are expected in 2021. Final results will be shared in 2022. The US Department of Defense personnel responsible for the protection of human subjects will have access to research records.

Right to Refuse or Withdraw

You have the right to refuse to participate. You may also stop participating at anytime you choose. We may remove you from the study at any time. If you are no longer participating, your data will be removed from this study. To withdraw from this study please contact Amy Beckley at info@proovtest.com or 1-833-776-6848 to ask to be removed. There are no consequences associated with withdrawing from the study.

Who to Contact

If you have any questions, concerns, or complaints about this research study, please contact us at info@mfbfertility.com or MFB Fertility, Inc., 1630A 30th St PMB 143, Boulder CO 80301 at any time.

Conflict of Interest

This study is conducted by and partially funded by MFB Fertility, Inc., which owns the Proov test devices being utilized in this study and thus has a financial interest in the outcome of the study. The investigator, Dr. Amy Beckley, owns equity in MFB Fertility, Inc. An institutional review board has reviewed this proposal. Their goal is to make sure that you are not harmed during this study. If you have any questions about your rights as a study participant, you may contact Solutions IRB at 1-855-226-4472 or by email: participants@solutionsirb.com

By answering the screening survey that follows, you agree:

1. You understand the purpose of the study

2. You are over the age of 18

3. You agree to participate in the study

If you have any questions please contact info@proovtest.com or 1-833-776-6848. We recommend you print a copy of this consent for your records.

Protocol Number: 2021/03/29

Approved: 04/06/2023

Expires: 04/16/2024