Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01363596 |
| Other study ID # |
00014070 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2006 |
| Est. completion date |
December 2020 |
Study information
| Verified date |
February 2022 |
| Source |
University of Utah |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
