Internet-based Study of Fertility and Early Pregnancy (PEEPS)

Infertility Clinical Trial

— PEEPS  

Official title:

Prospective Evaluation of the Elements of Pregnancy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904669
• Other study ID #: 2012H0128
• Secondary ID: 1R03HD073504-01
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: October 26, 2015
• Start date: July 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment with women completing daily journals for up to 12 months while trying to conceive and weekly through pregnancy if it occurs.

Description:

There is a dearth of knowledge regarding the role that preconception health plays in fertility and early pregnancy loss. Classical methods of conducting prospective pregnancy studies with preconception enrollment to answer these questions are time-consuming in terms of recruitment efforts and expensive to carry out. The purpose of this project is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment in the United States using the gold standard data collection approach of daily diaries during the trying to conceive period. We will accomplish this by enrolling 200 females of reproductive age who attempting to conceive and following them for up to 12 months and through pregnancy for those who become pregnant. Feasibility will be assessed by measuring: the number of women who screen eligible, the number of women who enroll, and compliance with journal use over time. We will also estimate the incidence of infertility, pregnancy and pregnancy loss as well as compare the demographics of women who enroll to the demographics of women who participate in community-based prospective pregnancy studies with preconception enrollment. The data from this project will be used to assess the feasibility of launching a larger prospective pregnancy study that is appropriately powered to examine the impact of preconceptional lifestyle factors on the incidence of infertility and early pregnancy loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Women

• Ages 18-44

• In a stable relationship

• Sexually active with a male partner

• Reliable daily access to the Internet

Exclusion Criteria:

• Woman or her partner has a known fertility problem

• Trying to conceive for three or more months.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Fertility
• Infertility
• Pregnancy

Locations

Country	Name	City	State
United States	The Ohio State University College of Medicine	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Courtney D.Lynch, PhD MPH	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number enrolled		One year	No
Secondary	Completeness of data collection	Percentage of the study that the participant completed: baseline questionnaire (Y/N); daily trying to conceive journals (%); weekly pregnancy journals (%); and delivery information (%).	Following 9-21 months of data collection	No