The Effect of Aflatoxin Metabolites Concentration in Follicular Fluid on Laboratory and Clinical Outcomes in ICSI

May 8, 2025 updated by: Romany Hany, Assiut University

The Effect of Aflatoxin Metabolites Concentration in Follicular Fluid on Laboratory and Clinical Outcomes in Intracytoplasmic Sperm Injection Cycles

Mycotoxins are secondary toxic metabolites produced by Aspergillus, Penicillium, and Fusarium species of fungi, when they infect and proliferate on various agricultural commodities either in the field and/or during storage. The well-known detrimental health effects of mycotoxins in humans include liver cancer, Balkan endemic nephropathy, child growth impairment, immune suppression, neural tube defects and death in acute exposure. However, growing evidence also suggests that mycotoxins may negatively influence human fertility.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Aflatoxins (AFs) contaminate different types of food and feed commodities, especially in hot and humid regions of the world . The major AFs are characterized as B1, B2, G1 and G2, among these four, B1 is best known because of its hepatocarcinogenic nature ]. AFs M1 and M2 are produced by biological metabolism of AFB1 and AFB2 from contaminated feed used by animals and excreted in milk and dairy products.

Natural occurrence of mycotoxins is present in a large part of the world food supply and bear potential threat to food safety and food security . From global perspective of food safety and food security, mycotoxins contamination of foods has gained much attention as potential health hazards for humans and animals.

Studies using animal and cell models indicate that zearalenone, deoxynivalenol, ochratoxin A and aflatoxin B1 can adversely affect fertility, mainly through damage to sex organs, gametes and disruption of steroidogenesis. For instance, animal models have indicated that exposure to the aforementioned mycotoxins can promote adverse effects on spermatozoa, sertoli and Leydig cell function, oocyte maturation, and uterine and ovarian development and function, both in vivo and ex vivo. They may also induce oxidative stress resulting in sperm DNA damage and subsequently, reduced fertilisation rates and lower embryo quality. Furthermore, mycotoxins may act as endocrine disrupters, altering the steroid hormone homeostasis, consequently leading to subfertility or infertility. In humans, zearalenone has been linked to precocious puberty in girls, correlating with extremely high serum oestrogen levels whereas aflatoxin B1 has been linked to poor sperm quality in infertile males. Considering that multiple exposures to these mycotoxins have been reported in humans and that there is a homology in organ systems between animals and humans, these findings may have clinical relevance in human infertility.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiu University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women undergoing IVF with ICSI as the method of insemination

Description

  1. Inclusion criteria:

    • Infertile women undergoing in vitro fertilization with intracytoplasmic sperm injection (IVF/ICSI) and fresh embryo transfer at the Unit aged between 18 and 39 years
    • Indications for IVF will be either ovulatory disorders, tubal disorders, or unexplained infertility.
    • All down-regulation protocols and all types of gonadotropins for ovarian stimulation will be included.

  2. Exclusion criteria:

    • Patients who refuse to participate in clinical research
    • Significant medical disease (hypertension, diabetes mellitus, cardiac disease, blood disease, etc.)
    • Male factor infertility.
    • Women with confirmed intrauterine lesions, i.e. polyps, submucous myomas, adhesions, septa or hydrosalpinges. Women with these lesions will be only included if corrected.
    • Women with expected poor response to ovarian stimulation; defined as antral follicle count less than 5, anti-mullerian hormone (AMH) less than 0.8 ng/mL or a history of previous IVF cycle that yielded less than 5 oocytes.
    • Women undergoing IVF not ICSI as the method of insemination for all retrieved oocytes.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
- Clinical pregnancy
Time Frame: 4 weeks from embryo transfer
- Clinical pregnancy: the presence of gestational sac and fetal pole with visible pulsations after 4 weeks from embryo transfer.
4 weeks from embryo transfer

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biochemical pregnancy
Time Frame: 2weeks from embryo transfer
positive bHCG in the serum measured 2 weeks after embryo transfer
2weeks from embryo transfer
Oocyte quality
Time Frame: Immediately after ovum pick up
Percentage of good quality oocytes: the number of good quality oocytes divided by the total number of retrieved oocytes x 100
Immediately after ovum pick up
Fertilization rate
Time Frame: 16-18 hours after insimination
the number of fertilized oocytes divided by the total number of injected oocytes x 100
16-18 hours after insimination
Embryo quality
Time Frame: 3-5 days after ovum pick up
- Percentage of good-quality embryos: the number of good-quality embryos divided by the total number of injected oocytes x 100 assessed on the day of embryo transfer
3-5 days after ovum pick up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Romany H Gerges, Resident, Assiut university

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Aflatoxins effect in ICSI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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