The Association Between Physical Activity and Pregnancy R... | NCT02451644

Studies
The Association Between Physical Activity and Pregnancy Rate Following Embryo Transfer

NCT02451644

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Apr 24, 2018Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Pregnancy

Interventions

pedometer

Countries

Israel

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

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jul 2019Estimated

Completion Date

Jul 2019Estimated

First Submitted Date

May 9, 2015

First Submission Date that Met QC Criteria

May 21, 2015

First Posted Date

May 22, 2015Estimated

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

Apr 21, 2018

Last Update Posted Date

Apr 24, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Shalom Mazaki-Tovi MD, Director of high risk Department, Sheba Medical CenterPrincipal Investigator

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Not provided

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

The study examines the association between the amount of physical activity of the patient, ie the number of steps daily / weekly, and the pregnancy rate after embryo transfer.

Detailed Description

Many studies have investigated the matter until today and still no reliable information about the relationship between physical activity and / or its intensity and the pregnancy rate after embryo transfer.

All patients that would take part in the study will be given a pedometer to measure steps for a month.

Measuring steps will begin preparation for embryo transfer and two weeks after. Collected information about pregnancy rate (BHCG positive or negative).

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high risk for PTD with pedometer	Experimental	Patient with high risk for preterm delivery including short cervix or rapture of membranes	Device: pedometer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pedometer	Device	patient will cary pedometer	high risk for PTD with pedometer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physical activity as assessed by number of steps recorded by pedometer		4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant speaks Hebrew or English speakers
The participant is eligible to legally provide informed consent

Exclusion Criteria:

The Subject in the wheelchair-bound or limited walking
Participant refuses to give informed consent

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shalom Mazaki tovi	Recruiting	Ramat Gan			Israel