International NaProTechnology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (iNEST)
NCT ID: NCT01363596
Last Updated: 2023-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
834 participants
OBSERVATIONAL
2006-01-31
2020-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Ineligibility for NPT evaluation and treatment, including menopause or ovarian failure (women)
18 Years
50 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Principal Investigators
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Joseph B Stanford, MD, CFCMC
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Family Health Center - St. James Place
Baton Rouge, Louisiana, United States
In His Image Family Medicine
Gardner, Massachusetts, United States
Mercy Medical Center
St Louis, Missouri, United States
MorningStar Family Health Center
Clinton, New Jersey, United States
South Jordan Health Center
Salt Lake City, Utah, United States
Etobicoke Urgent Care Centre Family Practice
Etobicoke, Ontario, Canada
Macierzyństwo i Życie Przychodnia Specjalistyczna
Lublin, , Poland
Life FertilityCare Clinic
Royal Leamington Spa, Warwickshire, United Kingdom
Countries
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References
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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.
Related Links
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iNEST Study Main Webpage
Other Identifiers
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00014070
Identifier Type: -
Identifier Source: org_study_id
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