InfertilityiNESTNCT01363596
International NaProTechnology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (iNEST)
An observational study of Infertility and Miscarriage, run by University of Utah at 8 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Infertility, Miscarriage
- What is being tested?
- Creighton Model System in conjunction with Natural Procreative Technology (NPT)
- How many people
- 834 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Jan 2006to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Inability to communicate in English.
- Ineligibility for NPT evaluation and treatment, including menopause or ovarian failure (women)
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States5 sites
Family Health Center - St. James Place
Baton Rouge, Louisiana, 70808
MorningStar Family Health Center
Clinton, New Jersey, 08867
In His Image Family Medicine
Gardner, Massachusetts, 01440
South Jordan Health Center
Salt Lake City, Utah, 84095
Mercy Medical Center
St Louis, Missouri, 63141
Canada1 site
Etobicoke Urgent Care Centre Family Practice
Etobicoke, Ontario, M9W 6N5
United Kingdom1 site
Life FertilityCare Clinic
Royal Leamington Spa, Warwickshire, CV31 1ES
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Infertility, Miscarriage
- Being tested
- Creighton Model System in conjunction with Natural Procreative Technology (NPT)
- Keywords
- Infertility, Fertility, Reproductive Medicine, Pregnancy, Conception, Miscarriage, Ovulation Detection, Cervical Mucus, IVF Alternative
- Medical subject headings
- Infertility, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creighton Model System in conjunction with Natural Procreative Technology (NPT)Other
Also called NaProTechnology, Ovulation Method, Fertility Awareness
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Creighton Model System in conjunction with Natural Procreative Technology (NPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
NPT Conception Rate
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.
Measured: 3 years
Conception Outcomes
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.
Measured: 3 years
Environmental Exposures
A secondary outcome of this study is to determine the association of environmental exposures with successful or unsuccessful treatment for infertility.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startJan 2006
- Primary completionDec 2016
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 834 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph B Stanford, MD, CFCMC, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363596
- Sponsor's protocol ID
- 00014070
- Acronym
- iNEST
- Status last verified
- Feb 2022
- First submitted
- 27 May 2011
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35974874
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Natural Procreative Technology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (iNEST)
- ClinicalTrials.gov ID
- NCT01363596
- Acronym / sponsor ID
- iNEST / 00014070
- Conditions
- Infertility, Miscarriage
- Keywords
- Infertility, Fertility, Reproductive Medicine, Pregnancy, Conception, Miscarriage, Ovulation Detection, Cervical Mucus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 834 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natural Procreative Technology (NPT) | – | Other: Creighton Model System in conjunction with 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to communicate in English.
- Ineligibility for NPT evaluation and treatment, including menopause or ovarian failure (women)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creighton Model System in conjunction with Natural Procreative Technology (NPT)Also: NaProTechnology, Ovulation Method, Fertility AwarenessPatients 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 | Natural Procreative Technology (NPT) |
Primary outcome
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 secondary outcomes
NPT Conception Rate
Time frame: 3 years
Conception Outcomes
Time frame: 3 years
Environmental Exposures
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Derived from this study: PubMed 35974874Stanford 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.
- iNEST Study Main WebpageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph B Stanford, MD, CFCMC principal investigator
University of Utah
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Miscarriage, run by University of Utah at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, Poland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPT Live Birth Rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01363596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.