Characterization of Methylation Pattern in Human Germ Cells of Patients Undergoing ICSI Treatment

April 11, 2024 updated by: Infertility Treatment Center Dortmund

Characterization of Methylation Pattern in Human Germ Cells of Patients With the Desire to Have Children Undergoing Intracytoplasmic Sperm Injection Treatment

There is increasing evidence that exposure to environmental factors in early development is associated with an increased risk of metabolic and other common diseases. These increased disease risks are likely due to environmental-induced epigenetic changes leading to dysregulation of genes and signaling cascades. The best studied epigenetic modification in this context is DNA methylation. Preliminary studies have already shown that an increased father age or intracytoplasmic sperm injection affects methylation pattern in sperm or umbilical cord blood of children. Unlike sperm, less is known about the methylation of human oocytes and their susceptibility to environmental factors. The aim of this study is to analyze the methylation pattern of immature oocytes of women with decreased fertility. Based on the results of a large number of oocytes from different women, risk assessments could be made for individual factors such as the age of the patient, as well as correlations between the occurrence of changes in gene expression and the unfulfilled desire to have children. In addition, the methylation patterns in sperm from 20 patients are to be examined as reference patterns.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Although more than five million children have been conceived worldwide through Assisted Reproduction Techniques (ARTs), little is known about potential effects of ART in later life. So far, the focus of reproductive research is based on the success rate of infertility treatment. There is increasing evidence that exposure to environmental substances, age of the patient or in vitro culture conditions in early development is associated with a life-long increased risk of metabolic and other common diseases. These increased disease risks are likely due to environmental-induced epigenetic changes leading to dysregulation of genes and signaling cascades. These include Beckwith-Wiedemann and Angelman syndrome.

The best studied epigenetic modification in this context is DNA methylation, which regulates the gene expression in a temporally and highly coordinated manner. Preliminary studies have already shown that an increased father age influences the pattern of methylation in the sperm and umbilical cord blood of children. Moreover, intracytoplasmic sperm injection (ICSI) also leaves epigenetic signatures in umbilical cord blood. Unlike sperm, little is known about the methylation of human oocytes and their susceptibility to environmental factors. The main reason for this is the difficulty of collecting human oocytes in sufficient numbers for genome-wide analysis. The aim of this study is to analyze the methylation pattern of immature oocytes, which are not suitable for further ICSI treatment, of women with decreased fertility. The products of gene expression and also the methylation of the DNA itself can be investigated using newly developed DNA sequencing methods. Based on the results of a large number of oocytes from different women, risk assessments could be made for individual factors such as the age of the patient, as well as correlations between the occurrence of changes in gene expression and the unfulfilled desire to have children. In addition, the methylation patterns in sperms from 20 patients are to be examined as reference.

Study Type

Observational

Enrollment (Estimated)

200

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 Locations

  • Germany
    • NRW
      • Dortmund, NRW, Germany, 44135
        • Recruiting
        • Infertility treatment center Dortmund
        • Contact:
          • Stefan Dieterle
          • Phone Number: 00492315575450
        • Principal Investigator:
          • Stefan Dieterle

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

female patients seeking ICSI treatment because of male subfertility

Description

Inclusion Criteria:

- healthy females without sterility factors

Exclusion Criteria:

  • Endometriosis
  • Polycystic ovary syndrome (PCO)
  • Neoplasia (ovary, Uterus, breast)
  • Anti-Müllerian hormone (AMH) <1 ng/ml

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: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Female Patients
ICSI treatment because of male subfertility

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Methylation pattern
Time Frame: 1 day (Directly after oocyte pick-up)
Analysis of methylation pattern in immature oocytes (not suitable for further ICSI treatment). Methylation will be pointed out as number of methylated gene loci in comparison to the overall amount of analyzed gene loci.
1 day (Directly after oocyte pick-up)
Gene expression
Time Frame: 1 day (Directly after oocyte pick-up)
Analysis of gene expression in immature oocytes (not suitable for further ICSI treatment) will be done by quantification of selected gene transcripts (in picogram).
1 day (Directly after oocyte pick-up)

Collaborators and Investigators

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

Sponsor

Infertility Treatment Center Dortmund

Collaborators

University of Wuerzburg

Investigators

  • Principal Investigator: Stefan Dieterle, MD, Infertility treatment center Dortmund

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)

July 1, 2018

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Methylation in Germ cells

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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