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

Courtney D.Lynch, PhD MPH

Status: Completed

Conditions: Infertility; Fertility; Abortion, Spontaneous; Pregnancy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01904669

2012H0128

1R03HD073504-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

161 participants in 1 patient group

Women who are trying to conceive

Description:

Women ages 18-44 without a history of fertility problems who are in a stable relationship with a male partner who have regular access to the Internet and have been trying to conceive \<3 months.