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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
International Institute for Restorative Reproductive Medicine
Information provided by (Responsible Party):
Joseph B. Stanford, MD, MSPH, University of Utah
ClinicalTrials.gov Identifier:
NCT01363596
First received: May 27, 2011
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Infertility
Miscarriage
Other: Creighton Model System in conjunction with Natural Procreative Technology (NPT)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Natural Procreative Technology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (iNEST)

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • NPT Live Birth Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • NPT Conception Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.

  • Conception Outcomes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.

  • Environmental Exposures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    A secondary outcome of this study is to determine the association of environmental exposures with successful or unsuccessful treatment for infertility.


Estimated Enrollment: 15000
Study Start Date: January 2006
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2026 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • NaProTechnology
  • Ovulation Method
  • Fertility Awareness

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363596

Locations
United States, Louisiana
Family Health Center - St. James Place
Baton Rouge, Louisiana, United States, 70808
United States, Massachusetts
In His Image Family Medicine
Gardner, Massachusetts, United States, 01440
United States, Missouri
Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, New Jersey
MorningStar Family Health Center
Clinton, New Jersey, United States, 08867
United States, Utah
South Jordan Health Center
Salt Lake City, Utah, United States, 84095
Canada, Ontario
Etobicoke Urgent Care Centre Family Practice
Etobicoke, Ontario, Canada, M9W 6N5
Poland
Macierzyństwo i Życie Przychodnia Specjalistyczna
Lublin, Poland
United Kingdom
Life FertilityCare Clinic
Leamington Spa, Warwickshire, United Kingdom, CV31 1ES
Sponsors and Collaborators
University of Utah
International Institute for Restorative Reproductive Medicine
Investigators
Principal Investigator: Joseph B Stanford, MD, CFCMC University of Utah
  More Information

Additional Information:
No publications provided

Responsible Party: Joseph B. Stanford, MD, MSPH, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01363596     History of Changes
Other Study ID Numbers: 14070
Study First Received: May 27, 2011
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Infertility
Fertility
Reproductive Medicine
Pregnancy
Conception
Miscarriage
Ovulation Detection
Cervical Mucus
IVF Alternative

Additional relevant MeSH terms:
Infertility
Abortion, Spontaneous
Genital Diseases, Male
Genital Diseases, Female
Pregnancy Complications

ClinicalTrials.gov processed this record on September 16, 2014