Clinical trial NCT01363596: International NaProTechnology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (iNEST)
Official title: International Natural Procreative Technology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (iNEST)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Miscarriage
Keywords: Infertility
Fertility
Reproductive Medicine
Pregnancy
Conception
Miscarriage
Ovulation Detection
Cervical Mucus
IVF Alternative
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-06-01
Enrollment: 834
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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)

Primary outcomes:
measure: NPT Live Birth Rate
timeFrame: 3 years
Secondary outcomes:
measure: NPT Conception Rate
timeFrame: 3 years
measure: Conception Outcomes
timeFrame: 3 years
measure: Environmental Exposures
timeFrame: 3 years
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Family Health Center - St. James Place
state: Louisiana
city: Gardner
country: United States
facility: In His Image Family Medicine
state: Massachusetts
city: Saint Louis
country: United States
facility: Mercy Medical Center
state: Missouri
city: Clinton
country: United States
facility: MorningStar Family Health Center
state: New Jersey
city: Salt Lake City
country: United States
facility: South Jordan Health Center
state: Utah
city: Etobicoke
country: Canada
facility: Etobicoke Urgent Care Centre Family Practice
state: Ontario
city: Lublin
country: Poland
facility: Macierzyństwo i Życie Przychodnia Specjalistyczna
city: Leamington Spa
country: United Kingdom
facility: Life FertilityCare Clinic
state: Warwickshire
Study officials:
affiliation: University of Utah
name: Joseph B Stanford, MD, CFCMC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.