Influence of Pb&Cd Seminal Plasma Level & ICSI

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04286633
Collaborator
(none)
50
7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Influence of Lead and Cadmium Seminal Plasma Level on Intracytoplasmic Sperm Injection (ICSI) Outcome
    Anticipated Study Start Date :
    May 1, 2022
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. The influence of lead and cadmium seminal plasma level on intracytoplasmic sperm injection (ICSI) outcome [baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Shaimaa Mostafa Atef Abdul-Rahman, Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04286633
    Other Study ID Numbers:
    • Pb&Cd seminal level&ICSI
    First Posted:
    Feb 27, 2020
    Last Update Posted:
    Jul 23, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 23, 2021