iNEST FAQ

What is the iNEST Study of Infertility and Miscarriage?

iNEST stands for the International NaProTechnology (NPT) Evaluation and Surveillance of Treatment. The purpose of the study is to investigate what happens to patients who inquire about treatment with NPT to help them conceive or maintain a pregnancy. We want to know what happens to these patients with treatment, or even if they decide not to undergo NPT treatment, decide against any treatment at all or choose another form of treatment all together.

What is NaProTechnology?

Natural Procreative Technology (NaProTechnology or NPT) is a standardized approach to infertility that identifies abnormalities of reproductive function and then applies medical or surgical interventions to maximize the chances of conception through normal sexual intercourse. It also includes medical support to maintain pregnancy. All therapy is monitored and adjusted based on tracking biomarkers of fertility, called NaProTracking, based on the Creighton Model Fertility Care system. Through NaProTracking, couples are taught to understand their own fertility cycles, and are empowered to manage their own fertility with medical support.

Why is this study important?

So far, studies of NPT effectiveness and outcomes have been done in individual centers. Working together will allow us to enroll a larger number of patients in a shorter time making it possible to better understand how well NPT works in different types of patients. This knowledge will allow us to continue to improve NPT care. This is similar to databases collected on other infertility treatments in some countries (see USA CDC and UK HFEA ), although iNEST will collect more detailed clinical information. In addition, iNEST will collect data from centers throughout the world offering NPT.

What do the researchers hope to learn?

We ask patients to provide us with a great deal of information about their treatment and their experiences. This will help us understand more about how infertility or miscarriage affects people, as well as what impact treatment has on them. We are obviously very interested in knowing how many people are able to conceive and have a live birth. We also are interested in knowing if there are any problems during the pregnancy or after. Again, we want to know this information not only for patients who are treated with NPT, but for those who use other treatments or who decided not to have any treatment at all.

Who is doing the study?

This study is being coordinated by the International Institute of Restorative Reproductive Medicine (International IRRM). The International IRRM is an organization of physicians and researchers dedicated to conducting and promoting research for restoring normal reproductive function. The principal investigator is Joseph B. Stanford, MD, MSPH, at the University of Utah, Salt Lake City, Utah, USA.

Who is eligible for the study?

All couples who inquire about undergoing NPT treatment to help conceive or maintain pregnancy from a participating physician are eligible for the study, whether or not they ultimately receive NPT treatment. We hope to enroll patients from all countries in which NPT is offered.

Is the study ethically approved?

Yes. The study has been approved by the Institutional (Ethics) Review Board at the University of Utah. As well, participating clinics obtain approval from the relevant local Ethics Review Board.

How big is the study?

It is hoped to enroll a thousand patients per year in the study.

How long will the study continue?

This is long-term evaluation of NPT treatment for infertility and miscarriage as it continues to improve over time. The study is planned to continue enrolling new couples for at least 20 years.

Where is the study being done?

The study is an international study and is available in most countries where NPT is offered. Currently, this includes practices in the USA, Canada, Europe, and Australia.

FAQs FOR PATIENTS

I am interested in being in the study, what do I do?

Please contact us and we will put you in touch with the IIRRM Member nearest to you. They will tell you how to enroll on the study.

What if I’m not sure if I want to receive NPT treatment?

You can still participate. Again, we want to know what happens to anyone who experiences infertility or miscarriage, whether you decide to pursue NPT treatment, some other kind of treatment, or even if you decide you do not want to have any type of treatment.

How long will I be in the study?

Couples enrolling in iNEST will be followed for 3 years from when they sign the consent form, whether or not they continue with treatment and whether or not they have a child. In addition, you may be contacted for future studies of long-term outcomes, such as child development. It will be your choice as to whether to participate in any additional follow-up studies. You may also withdraw from the iNEST study at any time you wish to do so.

What does participation involve?

You will need to sign a consent form that describes your participation in the study. There are separate detailed questionnaires for the woman and the man. You will then receive follow-up questionnaires every 6 months (for 3 years). Nothing further is required of you.

Why do I need to fill out questionnaires?

This study is about recording what happens to people who feel they need help to conceive or maintain pregnancy. We are interested in both medical and social factors. The best way to understand these issues is to ask you directly.

What if I don’t want to answer some of the questions?

You are free to answer, or not answer, any question on the questionnaire. Of course, complete answers will make your information more valuable for the study.

What if some of the questions don’t apply to me?

If you feel that a question does not apply to you, please simply draw a line through it. Writing a brief comment about why it does not apply to you would be very helpful to understand your situation.

What if I forget to return the questionnaire?

We will try to contact you and make certain that you are reminded about the questionnaires so that this doesn’t happen. You can also contact us and we will be happy to send you another questionnaire.

Will you collect any other information for the study?

As part of the study, we will ask you to sign a medical records release form. We will obtain and use medical information about your NPT treatment (if applicable). We may also obtain important information about other treatments or previous treatments.

Why do you need access to my medical information?

If you are receiving medical evaluation and treatment, we need specialized information that we don’t necessarily expect you to remember (such as dates and details of blood tests and other tests).

Will my information be safe?

The information is only made available to a very limited number of researchers. All analysis is done with de-identified data (no names or any other identifying information). Appropriate research procedures are followed to ensure that your privacy is maintained at all times.

Does participation in iNEST affect my NPT treatment?

Participating in the study in no way effects your NPT treatment, or any other kind of treatment you may have; the study is only meant to record and analyze what happens as a result of the treatment you and your doctor decide on.

Do I have to have blood tests?

Not for the iNEST study. NPT evaluation and treatment does involve blood tests. However, the iNEST study only records information and your experience; it doesn’t change the treatment or care you receive.

Will other tests be needed?

Again, not for the iNEST study, which only observes and records what tests are done. What tests you have depends on what decisions you make with your physician(s).

Is there any way I can get updates on what’s happening in the study?

Yes. We will provide regular progress notes on the study through this website.

Are there costs to be in the study?

No. Participating in iNEST will cost you nothing, nor will you receive any financial benefit as a result of being involved. There may, however, be costs associated with the treatment that you choose. You should ask your physician and center for details on this.

What are the benefits to being in this study?

There are no direct benefits to you for participation in iNEST. By sharing your experiences, you will help researchers better understand what happens to people who seek help conceiving or maintaining a pregnancy. This information will help doctors discover how effective NPT treatment is for different kinds of patients.

What are the risks of participating in iNEST?

The study itself only observes and records what happens and, thus has no known risks associated with it. Medical treatment of any sort may have some risks. You should consult your physician and the clinic providing care to be sure you understand the risks of any treatment that you choose.

Can I quit the study if I want to?

Yes. Any participant who wants to stop participating in the study may do so by contacting the study staff or principal investigator.

FAQs FOR PHYSICIANS

Who is funding this study?

At this time, the study is being supported through a small research grants from the University of Utah, International IRRM membership fees and donations in-kind from the researchers themselves. We are currently seeking additional sources of funding.

I’m an NPT doctor, how do I get involved?

Please join the International IRRM. You can then review the study protocol from the website. The next step is to send an email expressing your interest to our research director. A study representative will then contact you.

I’ve never heard of NPT. Can you tell me more about it?

Natural Procreative Technology (NaProTechnology or NPT) is a restorative approach to reproductive health, including treatment of infertility and prevention of miscarriage. NPT uses a standardized approach to infertility, by timing tests and interventions around a specialized fertility chart, which tracks biomarkers of ovulation and bleeding patterns. NPT uses standard fertility medications for luteal phase support, mucus enhancement, or ovulation induction, but does so in a way that is 1) timed to the patient’s natural fertility cycle (menstrual cycle); 2) closely monitored by hormonal assays each cycle; 3) adjusted to optimize ovulation and reproductive hormonal function. The purpose is to allow for restoration of reproductive function and in vivo conception. Information about scientific publications and training in NPT is available in our General FAQ’s.

What is the International IRRM?

The International IRRM is an organization of physicians and professional researchers dedicated to conducting and promoting research on medical and surgical methods to restore normal reproductive function. More information is available on this website.

How can I found out more?

Additional questions can be directed to study staff or principal investigator.

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