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

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.

Study Overview

• Status: Unknown
• Conditions: Fertilization in Vitro

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Shahar Kol, MD; Phone Number: 97247773232; Email: skol@rambam.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

IVF patients (women and men)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 22, 2016

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 0008-16-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be published in scientific journal. Individual researchers will have access to source data anonymously.