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

NCT ID: NCT02971280

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Fertilization in Vitro

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Shahar Kol MD

Director IVF Unit, principal investigator, Assistant clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Shahar Kol, MD

Role: CONTACT

Phone: 97247773232

Email: [email protected]

Other Identifiers

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0008-16-RMB

Identifier Type: -

Identifier Source: org_study_id