Influence of Pb&Cd Seminal Plasma Level & ICSI

NCT ID: NCT04286633

Last Updated: 2021-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-12-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Infertility, Male

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Mostafa Atef Abdul-Rahman

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Shaimaa Abdul-Rahman, master student

Role: CONTACT

01129239512

Ali Mahran, professor doctor

Role: CONTACT

01223971344

References

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Bernard A. Cadmium & its adverse effects on human health. Indian J Med Res. 2008 Oct;128(4):557-64.

Reference Type BACKGROUND
PMID: 19106447 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29594950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29936824 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20529961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2946611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12029976 (View on PubMed)

Other Identifiers

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Pb&Cd seminal level&ICSI

Identifier Type: -

Identifier Source: org_study_id

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