Influence of Heavy Metals Exposure on in Vitro Fertilizat... | NCT02971280

Studies
Influence of Heavy Metals Exposure on in Vitro Fertilization (IVF) Outcome

NCT02971280

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Nov 22, 2016Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Fertilization in Vitro

Interventions

Not provided

Countries

Not provided

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Nov 2017Estimated

Completion Date

Not provided

First Submitted Date

Nov 14, 2016

First Submission Date that Met QC Criteria

Nov 21, 2016

First Posted Date

Nov 22, 2016Estimated

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

Nov 21, 2016

Last Update Posted Date

Nov 22, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shahar Kol MD, Director IVF Unit, principal investigator, Assistant clinical Professor, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

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

Exposure to heavy metals may interfere with basic cellular functions, including DNA synthesis.

The aim of the study is to correlate heavy metals concentration in body fluids of reproductive importance and IVF outcome.

Detailed Description

Concentration of heavy metals will be measured in blood, urine, semen fluid and follicular fluid of IVF patients.

Study group: poor prognosis patients: repeated IVF failure, implantation failure, poor ovarian response, low sperm quality (according to WHO criteria) Control group: Good prognosis patients. Normal sperm count. Heavy metals concentrations will be measured using atomic absorption spectrometer, and will be correlated with IVF outcomes: number of mature oocytes obtained, fertilizations, embryos quality, and reproductive outcome post embryo transfer.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Live birth rate ("take-home baby")	IVF cycle resulting in pregnancy that ends in a live birth.	9 months from embryo transfer

Secondary Outcomes

Measure	Description	Time Frame
Clinical pregnancy rate	Gestational sac(s) seen by ultrasound 1 month after embryo transfer.	1 month from embryo transfer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Age of female patients: <=39
Age of male patients: 18-50

Exclusion Criteria:

Smoking
Alcohol/drug abuse
Long-term/chronic medications
Severe health/mental problems
Dental or other transplants
Fragile X mutations
Fertility preservation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

IVF patients (women and men)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shahar Kol, MD	Contact	97247773232		skol@rambam.health.gov.il

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Data will be published in scientific journal. Individual researchers will have access to source data anonymously.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided