International NaProTechnology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (iNEST)
Condition: Infertility; Miscarriage
MeSH terms: Infertility; Abortion, Spontaneous
Study type: Observational

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.
    

Intervention name(s): Creighton Model System in conjunction with Natural Procreative Technology (NPT)
Intervention type(s): Other
Intervention description(s): 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 name(s): NaProTechnology; Ovulation Method; Fertility Awareness
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.
      
Keywords: Infertility; Fertility; Reproductive Medicine; Pregnancy; Conception; Miscarriage; Ovulation Detection; Cervical Mucus; IVF Alternative