Influence of Pb&Cd Seminal Plasma Level & ICSI

July 22, 2021 updated by: Shaimaa Mostafa Atef Abdul-Rahman, Assiut University

The Influence of Lead and Cadmium Seminal Plasma Level on Intracytoplasmic Sperm Injection (ICSI) Outcome

To evaluate the influence of lead (pb) and cadmium (cd) seminal plasma level on embryo development and pregnancy rate during intracytoplasmic sperm injection (ICSI).

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The inability to have children, both by natural procreation and medically assisted reproduction, is not only a challenge for medical science but also an economic and social problem. Infertility is a complex disorder with multiple genetic and environmental causes (Gill et al.,2018) One of the factors that may be responsible for this phenomenon is contamination of the environment with heavy metals Two of the most widely-recognized reproductive toxins are lead (Pb) and cadmium (Cd) (Wdowiak et al., 2018).

Food, water and tobacco and smoking are the primary source of baseline exposure to lead and cadmium (Tong et al., 2000; Bernard, 2008) Each of cadmium and lead were inversely correlated with semen parameters as, ejaculate volume, sperm count, sperm concentration, live sperms and rapid mobility. ( Zaki et al.,2018).

Reproductive contaminants found in follicular fluid (FF) and seminal plasma may compromise the quality of oocytes and or sperm, which may become one of the risk factors for reproductive outcome. The data available suggests certain chemicals or their metabolite reaches the seminal plasma and/or FF, indicating their possible impact in In Vitro fertilization (IVF) outcome ,However, more studies are needed with regard to relationship between exposure level and affected parameters. (Kumar et al., 2010).

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

prospective cohort study to evaluate seminal plasma lead and cadmium level affects intracytoplasmic sperm injection out come

Description

Inclusion Criteria:

  • Isolated male infertility (oligozoospermia, astenozoospermia, teratozoospermia)
  • First ICSI cycle
  • Female partner ≤ 35 y-old

Exclusion Criteria:

  • • Wife age > 35 years

    • Frozen semen samples
    • Male partner with severe oligoasthenoteratozoospermia <5 × 106 / mL and 5% progressive motility, included globozoospermia and pinhead samples, and surgically retrieved sperms
    • Poor responder women
    • Women with abnormal endometrium at hCG trigger day.
    • Women with BMI > 31
    • Women with PCOS
    • Previous failed ICSI
    • OHSS)overian hyperstimulation syndrome)
    • Patients with systemic diseases affecting fertility
    • Patients on radiotherapy or receiving medications with gonadotoxic effect eg., chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The influence of lead and cadmium seminal plasma level on intracytoplasmic sperm injection (ICSI) outcome
Time Frame: baseline
evaluate the influence of lead (pb) and cadmium (cd) seminal plasma level on embryo development and pregnancy rate during intracytoplasmic sperm injection (ICSI).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pb&Cd seminal level&ICSI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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