International NaProTechnology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (iNEST)
iNEST
International Natural Procreative Technology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (iNEST)
1 other identifier
observational
834
4 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2006
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 27, 2023
February 1, 2022
10.9 years
May 27, 2011
April 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NPT Live Birth Rate
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 Outcomes (3)
NPT Conception Rate
3 years
Conception Outcomes
3 years
Environmental Exposures
3 years
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Inability to communicate in English.
- Ineligibility for NPT evaluation and treatment, including menopause or ovarian failure (women)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Family Health Center - St. James Place
Baton Rouge, Louisiana, 70808, United States
In His Image Family Medicine
Gardner, Massachusetts, 01440, United States
Mercy Medical Center
St Louis, Missouri, 63141, United States
MorningStar Family Health Center
Clinton, New Jersey, 08867, United States
South Jordan Health Center
Salt Lake City, Utah, 84095, United States
Etobicoke Urgent Care Centre Family Practice
Etobicoke, Ontario, M9W 6N5, Canada
Macierzyństwo i Życie Przychodnia Specjalistyczna
Lublin, Poland
Life FertilityCare Clinic
Royal Leamington Spa, Warwickshire, CV31 1ES, United Kingdom
Related Publications (1)
Stanford JB, Parnell T, Kantor K, Reeder MR, Najmabadi S, Johnson K, Musso I, Hartman H, Tham E, Winter I, Galczynski K, Carus A, Sherlock A, Golden Tevald J, Barczentewicz M, Meier B, Carpentier P, Poehailos K, Chasuk R, Danis P, Lipscomb L. International Natural Procreative Technology Evaluation and Surveillance of Treatment for Subfertility (iNEST): enrollment and methods. Hum Reprod Open. 2022 Aug 9;2022(3):hoac033. doi: 10.1093/hropen/hoac033. eCollection 2022.
PMID: 35974874DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph B Stanford, MD, CFCMC
University of Utah
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2011
First Posted
June 1, 2011
Study Start
January 1, 2006
Primary Completion
December 1, 2016
Study Completion
December 1, 2020
Last Updated
April 27, 2023
Record last verified: 2022-02