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

NCT03565107 | Completed

• 1 other identifier: Methylation in Germ cells
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Female Infertility; Gene Deregulation

Keywords

Epigenetic; Female age; Gene regulation; Methylation pattern

Outcome Measures

Primary Outcomes (2)

• Methylation pattern

  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

  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)

Study Arms (1)

Female Patients

ICSI treatment because of male subfertility

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

female patients seeking ICSI treatment because of male subfertility

You may qualify if:

• \- healthy females without sterility factors

You may not qualify if:

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

Sponsors & Collaborators

• Infertility Treatment Center Dortmund: lead
• University of Wuerzburg: collaborator

Study Sites (1)

Infertility treatment center Dortmund

Dortmund, North Rhine-Westphalia, 44135, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Immature oocytes

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Stefan Dieterle, MD

  Infertility Treatment Center Dortmund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 21, 2018
• Study Start: July 1, 2018
• Primary Completion: July 17, 2024
• Study Completion: October 31, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)