CompletedNot Applicable

International NaProTechnology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (iNEST)

United States, Canada, Poland834 participantsStarted 2006-01

Plain-language summary

NaProTechnology (NPT) is a treatment option for infertility or miscarriage that identifies issues in a couple's fertility and fixes them to the extent possible by medical intervention. An important part of NPT is teaching couples to monitor the signs and symptoms of the woman's fertility cycle (menstrual cycle) with the Creighton Model FertilityCare System (CrMS). The purpose of the study is to look at outcomes among couples who consider or get NPT treatment to help them have a live birth. Results from the study will be used to answer questions such as: How many couples who use NPT get pregnant and have a baby? How can NPT treatment be improved? Does NPT treatment have fewer long-term health risks for the resulting children than other fertility treatments? What types of characteristics or environmental exposures influence whether NPT will be successful for a specific couple? To be eligible for the iNEST study, a couple must have a consultation with a NPT-trained clinician who is participating in iNEST.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All couples who are considering NPT treatment to help them conceive or maintain a pregnancy and who present to participating physicians or providers during the time of the study. Exclusion Criteria: * Inability to communicate in English. * Ineligibility for NPT evaluation and treatment, including menopause or ovarian failure (women)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NPT Live Birth Rate

Timeframe: 3 years

Trial details

NCT IDNCT01363596

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Infertility trials