Infertility, MaleNCT04286633
Influence of Pb&Cd Seminal Plasma Level & ICSI
An observational study of Infertility, Male, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Infertility, Male
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: prospective cohort study to evaluate seminal plasma lead and cadmium level affects intracytoplasmic sperm injection out come
Who may be able to join
- Isolated male infertility (oligozoospermia, astenozoospermia, teratozoospermia)
- First ICSI cycle
- Female partner ≤ 35 y-old
Who cannot join
- • 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
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).
- Conditions
- Infertility, Male
- Medical subject headings
- Infertility, Male
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 May 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mostafa Atef Abdul-Rahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286633
- Sponsor's protocol ID
- Pb&Cd seminal level&ICSI
- Status last verified
- Jul 2021
- First submitted
- 25 Feb 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bernard A. Cadmium & its adverse effects on human health. Indian J Med Res. 2008 Oct;128(4):557-64.
PubMed 19106447Gill 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 29594950Wdowiak 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 29936824Kumar 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 20529961Kruger 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 2946611Tong 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Lead and Cadmium Seminal Plasma Level on Intracytoplasmic Sperm Injection (ICSI) Outcome
- ClinicalTrials.gov ID
- NCT04286633
- Acronym / sponsor ID
- Pb&Cd seminal level&ICSI
- Conditions
- Infertility, Male
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- prospective cohort study to evaluate seminal plasma lead and cadmium level affects intracytoplasmic sperm injection out come
Key inclusion criteria (3 listed)
- Isolated male infertility (oligozoospermia, astenozoospermia, teratozoospermia)
- First ICSI cycle
- Female partner ≤ 35 y-old
Key exclusion criteria (11 listed)
- • Wife age > 35 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Background: PubMed 19106447Bernard A. Cadmium & its adverse effects on human health. Indian J Med Res. 2008 Oct;128(4):557-64.
- Background: PubMed 29594950Gill 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.
- Background: PubMed 29936824Wdowiak 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.
- Background: PubMed 20529961Kumar 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.
- Background: PubMed 2946611Kruger 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.
- Background: PubMed 12029976Tong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Male, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa Abdul-Rahman, master student (01129239512, dr.shaimaa2021@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influence of lead and cadmium seminal plasma level on intracytoplasmic sperm injection (ICSI) outcome (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04286633, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.