The Impact of Lifestyle Behaviors on In Vitro Fertilizati... | NCT01119391

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

NCT01119391

Sponsor

Boston IVF

Status

Completed

Last Update Posted

Feb 4, 2016Estimated

Enrollment

118Actual

Phase

Not provided

Conditions

Infertility

Interventions

There was no intervention; this was a survey only study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

May 5, 2010

First Submission Date that Met QC Criteria

May 6, 2010

First Posted Date

May 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2016

Last Update Posted Date

Feb 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing IVF		Women undergoing an in vitro fertilization cycle	Behavioral: There was no intervention; this was a survey only study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
There was no intervention; this was a survey only study	Behavioral	There was no intervention; this was a survey only study	Patients undergoing IVF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Pregnancy Rates		Approximately 28 days (1 IVF cycle)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alice D Domar, PhD	Boston IVF	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston IVF		Waltham	Massachusetts	02451	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22217965	Derived	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.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases