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

• Conditions: Fertilization in Vitro

• Registration Number: NCT02971280
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-21
• Last Update Submitted: 2016-11-21
• Study First Posted: 2016-11-22
• Last Update Posted: 2016-11-22
• Primary Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	1 month from embryo transfer	Gestational sac(s) seen by ultrasound 1 month after embryo transfer.