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Status unknownNCT04286633Updated Jul 23, 2021

Influence of Pb&Cd Seminal Plasma Level & ICSI

An observational study in Infertility, Male, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-23.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 75 Years
Sex
All
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Study 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).

Read the 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).

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Conditions studied

  • Infertility, Male
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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 50 is below the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

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

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

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Bernard A. Cadmium & its adverse effects on human health. Indian J Med Res. 2008 Oct;128(4):557-64. PubMed 19106447 ↗
  • Gill K, Rosiak A, Gaczarzewicz D, Jakubik J, Kurzawa R, Kazienko A, Rymaszewska A, Laszczynska M, Grochans E, Piasecka M. The effect of human sperm chromatin maturity on ICSI outcomes. Hum Cell. 2018 Jul;31(3):220-231. doi: 10.1007/s13577-018-0203-4. Epub 2018 Mar 29. PubMed 29594950 ↗
  • Wdowiak A, Wdowiak E, Bojar I. Evaluation of trace metals in follicular fluid in ICSI-treated patients. Ann Agric Environ Med. 2017 Jun 23;25(2):213-218. doi: 10.26444/aaem/75422. Epub 2017 Jun 23. PubMed 29936824 ↗
  • Kumar S, Mishra VV. Review: Toxicants in reproductive fluid and in vitro fertilization (IVF) outcome. Toxicol Ind Health. 2010 Sep;26(8):505-11. doi: 10.1177/0748233710373081. Epub 2010 Jun 7. PubMed 20529961 ↗
  • Kruger TF, Menkveld R, Stander FS, Lombard CJ, Van der Merwe JP, van Zyl JA, Smith K. Sperm morphologic features as a prognostic factor in in vitro fertilization. Fertil Steril. 1986 Dec;46(6):1118-23. doi: 10.1016/s0015-0282(16)49891-2. PubMed 2946611 ↗
  • Tong S, Von Schirnding YE, Prapamontol T. [Environmental lead exposure: a public health problem with global dimensions]. Servir. 2000 Jan-Feb;49(1):35-43. No abstract available. Portuguese. PubMed 12029976 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04286633
Lead sponsor
Assiut University
Responsible party
Shaimaa Mostafa Atef Abdul-Rahman (Doctor, Assiut University) — Principal investigator
First posted
Feb 27, 2020
Start date
May 1, 2022 (estimated)
Primary completion
Nov 1, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Jul 23, 2021

Study contacts

Shaimaa Abdul-Rahman, master student
Contact
dr.shaimaa2021@gmail.com
01129239512
Ali Mahran, professor doctor
Contact
alimahran@aun.adu.eg
01223971344

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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