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

April 25, 2023 updated by: University of Utah

International Natural Procreative Technology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (iNEST)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infertility is a common problem. Natural procreative technology (NaProTechnology, NPT) is a standardized approach to the treatment of infertility that seeks to correct underlying reproductive problems. NPT incorporates many standard infertility treatments (e.g., drugs to stimulate ovulation, natural hormones, and other medical and surgical interventions) to maximize the probability of pregnancy from normal sexual intercourse. NPT evaluation identifies abnormalities of the woman's reproductive cycle (menstrual cycle) that may be correctable by medical intervention. The male is also evaluated.

An integral part of NPT is teaching women to observe and chart the biomarkers of their fertility (menstrual) cycle, based on changes in vaginal discharge (resulting from uterine bleeding and cervical fluid production). This charting of fertility biomarkers is done according to the Creighton Model FertilityCare System (CrM). The CrM alerts women when ovulation is approaching within the next few days and therefore intercourse is most likely to result in pregnancy, even for subfertile couples. The CrM also gives the physician or provider a record that can be used as a standardized basis for doing diagnostic tests timed in reference to ovulation. The physician can also employ medications to enhance ovulation, ovarian hormonal production, or cervical fluid production, and use the CrM chart to assess the immediate response of the woman to treatment. Where appropriate, NPT may also include medical treatment for male factor infertility, and for prior miscarriage.

Formal evaluation of the outcomes of NPT in medical practice has been done in a few studies based on single medical practices. This is a multi-national prospective observational study to measure the generalizability of this approach to multiple populations and settings, and characteristics of patients that may correlate with the likelihood of treatment success.

This is an observational study. Patients will receive whatever care they choose to receive. Couples receiving NPT treatment will be compared to those declining NPT treatment, waiting for NPT treatment, receiving other treatment, or stopping treatment. Interventions received, conceptions, and outcomes of conceptions will be followed for up to 3 years for each couple entering the study.

Study Type

Observational

Enrollment (Actual)

834

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Etobicoke, Ontario, Canada, M9W 6N5
        • Etobicoke Urgent Care Centre Family Practice
  • Poland
      • Lublin, Poland
        • Macierzyństwo i Życie Przychodnia Specjalistyczna
  • United Kingdom
    • Warwickshire
      • Leamington Spa, Warwickshire, United Kingdom, CV31 1ES
        • Life FertilityCare Clinic
  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Family Health Center - St. James Place
    • Massachusetts
      • Gardner, Massachusetts, United States, 01440
        • In His Image Family Medicine
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Medical Center
    • New Jersey
      • Clinton, New Jersey, United States, 08867
        • MorningStar Family Health Center
    • Utah
      • Salt Lake City, Utah, United States, 84095
        • South Jordan Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Couples eligible for this study will be 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 their participation in the study.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Natural Procreative Technology (NPT)
Patients who are treated or who consider being treated with Natural Procreative Technology (NPT) for infertility or history of spontaneous abortion.
Other: Creighton Model System in conjunction with Natural Procreative Technology (NPT)
Patients will learn the Creighton Model System to chart their fertility biomarkers, and this information will then be used by their physician in conjunction with Natural Procreative Technology (NPT) to evaluated and treat infertility or history of spontaneous abortion.
Other Names:
  • Ovulation Method
  • Fertility Awareness
  • NaProTechnology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NPT Live Birth Rate
Time Frame: 3 years
The main outcome of this study is the proportion of subjects that had a live birth at various time points up to three years after beginning treatment with NPT, compared to couples who do not receive NPT treatment, or who cease to receive NPT treatment.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NPT Conception Rate
Time Frame: 3 years
A secondary outcome of this study is the proportion of subjects that conceived (clinical pregnancy) at various time points up to three years after beginning treatment with NPT, compared to couples who do not receive NPT treatment, or who cease to receive NPT treatment.
3 years
Conception Outcomes
Time Frame: 3 years
A secondary outcome of this study is to explore outcomes of conceptions and determine what proportion had a live birth, spontaneous abortion, or other pregnancy outcome.
3 years
Environmental Exposures
Time Frame: 3 years
A secondary outcome of this study is to determine the association of environmental exposures with successful or unsuccessful treatment for infertility.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

International Institute for Restorative Reproductive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

May 27, 2011

First Posted (Estimate)

June 1, 2011

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00014070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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