Natural Procreative Technology Evaluation and Surveillance of Treatment for Infertility and Miscarriage

NCT ID: NCT02925390

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-09-10

Brief Summary

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.

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)

Conditions

Infertility and Miscarriage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Patrick Yeung Jr., MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Yeung, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

26221

Identifier Type: -

Identifier Source: org_study_id