NCT01404858

Brief Summary

The purpose of this study is to prospectively examine the impact of various lifestyle habits in both men and women on the outcome of in vitro fertilization. There are 25 infertility centers in the United States which use the electronic medical record collection entity eIVF, made by Practice Highway, to collect medical and demographic information on the patients who are undergoing treatment at these centers. Information on every aspect of each cycle is also electronically collected daily during each cycle. Demographic and lifestyle information will be collected on all patients prior to cycle start and lifestyle habit information will be collected each time a patient logs onto the patient portal, which averages every few days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

2.4 years

First QC Date

July 27, 2011

Last Update Submit

February 3, 2016

Conditions

Infertility

Keywords

IVFLifestyle habits

Outcome Measures

Primary Outcomes (1)

  • Clinical Pregnancy Rates

    Approximately 28 days (1 IVF cycle)

Study Arms (1)

Patients undergoing IVF

Behavioral: There is no intervention; this is a survey only study

Interventions

There is no intervention; this is a survey only studyBEHAVIORAL

There is no intervention; this is a survey only study

Patients undergoing IVF

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women undergoing IVF at a infertility clinic who uses eIVF, an electronic medical record collection entity specifically for IVF patients

You may qualify if:

  • Eligible patients include, any patient whose:
  • infertility clinic uses eIVF
  • is scheduled to undergo an IVF cycle
  • has access to the internet on a daily basis
  • can read and understand English
  • logs onto the patient portal on eIVF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Alice D Domar, PhD

    Boston IVF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Alice D. Domar, PhD

Study Record Dates

First Submitted

July 27, 2011

First Posted

July 28, 2011

Study Start

September 1, 2011

Primary Completion

February 1, 2014

Study Completion

November 1, 2014

Last Updated

February 4, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)