We are inviting you to take part in a research study investigating a new use for an FDA-approved drug as a pre-treatment to potentially improve the chances of pregnancy for women with Endometriosis who are undergoing IVF/ET treatment.
The PREGnant Study will enroll about 400 women with Endometriosis who are planning to undergo IVF treatment within the next year. The study will not require you to travel to any other clinic, aside from your reproductive endocrinologist; any data required will be digitally requested through your provider and/or laboratory. This study involves taking the investigational pre-treatment drug (or placebo), twice daily for approximately two months prior to your IVF/ET procedure.
There is no cost to take part in the PREGnant Study. In addition, participants will receive up to $100 for participation, which will last for about six months. Participation in this study does not cover the cost of IVF procedures. No health insurance is required to participate.
You may qualify for the PREGnant Study if you:
- Are between the ages of 18 to 40 years old, (inclusive)
- Have a diagnosis of Endometriosis
- Are planning or thinking of undergoing In vitro fertilization (IVF) – Embryo Transfer (ET) to become pregnant within the next year
Sign Up
What happens if I sign up? We will let you know immediately if you pre-qualify to participate or notify you if/when a spot becomes available. The study team will then contact you and you may have the opportunity to participate if qualified.
If you think you might like to participate in the PREGnant Study or would like more information, please enter your information below so we can see if you may qualify and can contact you about the study. Keep in mind that participation is entirely voluntary. If you do decide to take part in a study, you may change your mind about participating at any time.
About Endometriosis and Pregnancy
Endometriosis is a fairly common condition and has been estimated to affect up to 10-15% of reproductive aged women.1 Symptoms commonly present during the reproductive years, being most widespread between 25–35 years of age.2
The association between Endometriosis and infertility is well documented, however a definite cause-effect relationship is still unknown. The prevalence of Endometriosis in women experiencing infertility is 25-50%, where 30–50% of women with Endometriosis have infertility.3
Endometriosis can cause severe pain and infertility in 35-50% of women.3 IVF is a common, effective technique used to treat infertility due to many conditions, including endometriosis. However, pregnancy rates in women who have infertility due to endometriosis are low in comparison to infertility caused by other conditions.3
Frequently Asked Questions
What is a research study?
A research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug – these may include how well an investigational study drug works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients, including new uses for drugs that are already FDA approved.
Why are research studies important?
A research study is the process by which new and innovative medications, interventions, and treatments are approved and brought to market, so people can live happier and healthier lives. Even over-the-counter medications, such as NSAIDs, you may have used to counteract a headache, have gone through the clinical research study process before it was available at your local pharmacy.
What is the purpose of the PREGnant Study?
The PREGnant Study is investigating a new use for an FDA-approved drug as pre-treatment for women with Endometriosis who are undergoing IVF/ET treatment, to see if it can improve the chances of pregnancy when taken alongside IVF/ET.
What will the PREGnant Study involve?
The PREGnant Study will enroll about 400 participants with Endometriosis who are planning to undergo IVF treatment to become pregnant within the next year.
The study will not require you to travel to any other clinic, aside from your reproductive endocrinology provider; any data required will be digitally requested through your reproductive endocrinology provider and/or laboratory. This study involves taking the investigational pre-treatment drug (or placebo), twice daily for approximately two months prior to your IVF procedure.
Will I receive compensation?
Those who qualify and take part in the study will receive up to $100. Please discuss this with the study team when they contact you.
Is there a cost to participate?
There is no cost to participate in the PREGnant Study. If you qualify, you will receive all study-related care from a dedicated team of medical professionals, including the investigational pre-treatment drug, at no cost.
What else do I need to consider?
The research team will be able to explain more about what the PREGnant Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
About the PREGnant Study
The PREGnant Study will enroll about 400 participants with Endometriosis who are planning to undergo In vitro Fertilization (IVF) – Embryo Transfer (ET) treatment to become pregnant within the next year.
The study will include up to 5 visits to your reproductive endocrinologist provider over approximately 6 months.
The study will not require you to travel to any other clinic, aside from your reproductive endocrinology provider; any data required will be digitally requested through your reproductive endocrinologist provider and/or laboratory. This study involves taking the investigational pre-treatment drug (or placebo), twice daily for approximately two months prior to your IVF/transfer procedure.
Who can take part in the PREGnant Study?
You may qualify for the PREGnant Study if you:
- Are between the ages of 18 to 40 years old, (inclusive)
- Have a diagnosis of Endometriosis
- Are planning or thinking of undergoing In vitro fertilization (IVF) – Embryo Transfer (ET) to become pregnant within the next year
Participants will receive up to $100 for taking part in the PREGnant Study. Participation in this study does not cover the cost of IVF procedures. Insurance is not required to participate in the study. All study-related care, including the FDA-approved drug, to be investigated as a pre-treatment, is provided at no cost.
You will receive study-related care throughout the study from a team of experienced doctors and nurses prior to your scheduled treatment with your reproductive endocrinology team.
The PREGnant Study is investigating a new use for an FDA-approved drug as pre-treatment for women with Endometriosis who are undergoing IVF/ET treatment, to see if it can improve the chances of pregnancy when taken alongside IVF/ET.