Natural Procreative Technology Evaluation and Surveillance of Treatment for Infertility and Miscarriage (Fertility)

September 9, 2020 updated by: Patrick Yeung Jr., MD, St. Louis University

This study involves research, and the purpose of this study is to evaluate live birth rates among couples who are treated by Natural procreative technology, (NPT) for infertility and miscarriage.

Comparisons will be made to those declining NPT treatment, waiting for NPT treatment, receiving other treatment, or stopping treatment. The investigator seeks to document specific pregnancy rates for different factors such as age and type of infertility diagnosis. Investigators will also assess characteristics of environmental exposures that may be associated with infertility. Couples will be followed for up to three years, regardless of when they begin NPT treatment, or whether they continue treatment. Data from all couples will be useful for this study, regardless of their individual circumstances or actual treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a prospective cohort observational study. Couples presenting for possible treatment with NPT will be recruited for participation in the study. No randomization will occur. If a couple agrees to participate, investigators will collect information in three ways:

  1. Questionnaires. (standard of care) These will be done at entry (SOC) to the study, on an annual basis for up to three years (research related), for any pregnancy, or whenever a patient exits the study. Questionnaires may be done by mail, email, or telephone. Each questionnaire has a woman's and a man's version, except the pregnancy questionnaire, which only has a woman's version. Each questionnaire will take approximately 30-45 minutes to complete.
  2. The subject's own Creighton Model fertility charts. (standard of care)
  3. Information about NPT treatment and pregnancies from the medical records of their NPT physician(s). (standard of care)

Study Type

Observational

Enrollment (Actual)

46

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Couples seeking NPT treatment or consultation to achieve pregnancy, to maintain pregnancy, or for fertility-related health issues will recruited from our practice. Providers will present the study information to the patients at their initial visit. No recruitment by phone or mail will be done.

Description

Inclusion Criteria:

  • Couple or women, seeking NPT treatment or consultation to achieve pregnancy, to maintain pregnancy, or for fertility-related health issues.
  • Couple or women who is seeking pregnancy WITHIN the coming year.

Exclusion Criteria:

  • Couple or women is not a candidate for NPT for pregnancy (for example, couple or women is medically sterile or medically too high risk for pregnancy).
  • Couple or women is not able to provide informed consent (for example, language barriers).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rates over time for patients who are treated with natural procreative technology
Time Frame: 3 years
to determine what the live birth rates are over time for patients who are treated with natural procreative technology (NPT) for infertility or history of spontaneous abortion, and how the live birth rate may vary by patient characteristics, especially the age of the woman, prior pregnancy, and underlying diagnoses
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis University

Investigators

  • Principal Investigator: Patrick Yeung, MD, St. Louis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

September 10, 2020

Study Completion (Actual)

September 10, 2020

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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