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

NCT02925390 | Completed

• 1 other identifier: 26221
• Study Type: observational
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility and Miscarriage

Outcome Measures

Primary Outcomes (1)

• live birth rates over time for patients who are treated with natural procreative technology

  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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• St. Louis University: lead

MeSH Terms

Conditions

Infertility; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Patrick Yeung, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 5, 2016
• Study Start: September 1, 2016
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share