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The Impact of Lifestyle Behaviors on In Vitro Fertilization (IVF) Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01119391
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Alice D. Domar, PhD, Boston IVF

Tracking Information
First Submitted Date May 5, 2010
First Posted Date May 7, 2010
Last Update Posted Date February 4, 2016
Study Start Date July 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2010)
Clinical Pregnancy Rates [ Time Frame: Approximately 28 days (1 IVF cycle) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Impact of Lifestyle Behaviors on In Vitro Fertilization (IVF) Outcome
Official Title The Impact of Lifestyle Behaviors on IVF Outcome
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Women about to undergo an in vitro fertilization cycle at Boston IVF
Condition Infertility
Intervention Behavioral: There was no intervention; this was a survey only study
There was no intervention; this was a survey only study
Study Groups/Cohorts Patients undergoing IVF
Women undergoing an in vitro fertilization cycle
Intervention: Behavioral: There was no intervention; this was a survey only study
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 6, 2010)
118
Original Actual Enrollment Same as current
Actual Study Completion Date April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01119391
Other Study ID Numbers 20091005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Alice D. Domar, PhD, Boston IVF
Original Responsible Party Same as current
Current Study Sponsor Boston IVF
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Alice D Domar, PhD Boston IVF
PRS Account Boston IVF
Verification Date February 2016