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NCT02971280 Clinical Trial

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

Fertilization in Vitro Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02971280
Other study ID # 0008-16-RMB
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 14, 2016
Last updated November 21, 2016
Start date November 2016

Study information
Verified date November 2016
Source Rambam Health Care Campus
Contact Shahar Kol, MD
Phone 97247773232
Email skol@rambam.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Outcome
Type Measure Description Time frame Safety issue
Primary Live birth rate ("take-home baby") IVF cycle resulting in pregnancy that ends in a live birth. 9 months from embryo transfer No
Secondary Clinical pregnancy rate Gestational sac(s) seen by ultrasound 1 month after embryo transfer. 1 month from embryo transfer No
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