NCT01958424

Brief Summary

The purpose of this study is to examine the effect of metabolic syndrome in over-weight women on IVF treatment outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

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

First Submitted

Initial submission to the registry

October 6, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 11, 2016

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

October 6, 2013

Last Update Submit

May 10, 2016

Conditions

Metabolic Syndrome

Keywords

metabolic syndromein vitro fertilizationc reactive proteinover-weight womenovarian stimulation

Outcome Measures

Primary Outcomes (1)

  • success or failure of ivf treatment

    success or failure of a treatment will be determined by beta-Human chorionic gonadotropin test, number of oocyte retrieved or fertilized and embryos quality.

    within 1 year from intiation of ivf treatment

Secondary Outcomes (2)

  • blood levels of C-reactive protein

    within 1 year from initiation of ivf treatment

  • follicle liquid levels of C-reactive protein

    within 1 year from initiation of ivf treatment

Study Arms (2)

women with metabolic syndrome

women undergoing ivf treatment who have BMI\>25 and meet the criteria for metabolic syndrome

women without metabolic syndrome

women undergoing ivf treatment who have BMI\>25 and who do not meet the criteria for metabolic syndrome

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women undergoing ivf treatment in "Meir" medical center in "Kfar-Saba, Israel

You may qualify if:

  • women undergoing ivf treatment

You may not qualify if:

  • inflammatory disease
  • acute conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapir Medical Center, Meir Hospital

Kfar Saba, Israel, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Amir Waiser, M.D

    "Meir", Medical centere

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2013

First Posted

October 9, 2013

Study Start

April 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 11, 2016

Record last verified: 2013-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)