NCT01119391

Brief Summary

Many women undergoing in vitro fertilization (IVF) ask their doctor if there are any behaviors they should avoid, or any behaviors they should emphasize during their IVF cycle. This study examines the effects of health habits surrounding exercise, smoking, alcohol, sleep, caffeine, herbal medications, acupuncture, and diet on pregnancy rates during IVF cycles. The purpose of this study is to determine if lifestyle behaviors have a significant impact on pregnancy rates during treatment with IVF. This is an observational study conducted at a private academically-affiliated infertility clinic and includes 118 women ages 44 and below scheduled to undergo IVF treatment. All subjects were asked to complete a health history survey at the time of enrollment and a daily survey during each day of their IVF cycle. The primary outcome is clinical pregnancy rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

May 5, 2010

Last Update Submit

February 3, 2016

Conditions

Keywords

IVFLifestyle habits

Outcome Measures

Primary Outcomes (1)

  • Clinical Pregnancy Rates

    Approximately 28 days (1 IVF cycle)

Study Arms (1)

Patients undergoing IVF

Women undergoing an in vitro fertilization cycle

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

Interventions

There was no intervention; this was a survey only study

Patients undergoing IVF

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women about to undergo an in vitro fertilization cycle at Boston IVF

You may qualify if:

  • Female Boston IVF infertility patient undergoing IVF treatment
  • Age 18-44 years
  • Able to read, understand and sign the informed consent in English
  • Willing and able to comply with study requirements
  • Must be well versed in using a personal computer and the internet and must have access to an internet-connected computer seven days per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

Related Publications (1)

  • Domar AD, Conboy L, Denardo-Roney J, Rooney KL. Lifestyle behaviors in women undergoing in vitro fertilization: a prospective study. Fertil Steril. 2012 Mar;97(3):697-701.e1. doi: 10.1016/j.fertnstert.2011.12.012. Epub 2012 Jan 3.

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

May 5, 2010

First Posted

May 7, 2010

Study Start

July 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 4, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations