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Completed

NCT Number: NCT04256668

Human Sperm Epigenetics in Embryonic Development.

A total of 60 men (40 with a history of infertility and treatment with assisted reproduction and 20 infertile controls achieving conception naturally) will be asked to provide at least one semen sample each for conventional semen analysis including measurement of DNA-fragmentation and semen preparation with swim-up. The prepared semen sample will then analyzed by comprehensive microscopy analyses aiming at identifying distinct subpopulations of spermatozoa based on chromatin density and composition, mitochondrial and acrosome function and epigenetic markers. In addition, spermatozoa samples of selected individuals will be subjected to comprehensive analyses of the chromatin and RNA expression status using epigenomic approaches.

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Key information

Conditions

Male Infertility Epigenetic Disorder Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

28 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Basel, 4031, Switzerland

About this study

Hitherto male infertility has been defined by conventional semen analysis only, which mainly consists of determining concentration, progressive mobility and morphology of spermatozoa. However, the diagnostic accuracy of conventional semen analysis is poor and has very limited relationship with the outcome of assisted reproductive medicine. Preliminary data suggest that differences in chromatin density and epigenetic status of sperm may be more relevant, in particular with respect to the growth and differentiation of early embryos.

Chromatin density, morphology, mitochondrial status and epigenetic state in sperm of infertile men with disturbances of early embryo development in vitro will be compared with those of infertile men with normal embryo development and with fertile controls.

Primary outcome:

Features of chromatin density will be determined through staining of large numbers of spermatozoa. Differences in the staining results will be compared with known fertility outcome.

Secondary outcome:

Development of significant staining parameters towards the selection against sperm with reduced embryonic competence and/or in favor of sperm supporting embryonic development after assisted reproduction, thereby using flow cytometry and sorting (FACS) .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men with a history of infertility. Sperm concentration must be >15 millions per ml.

Exclusion criteria

  • No vulnerable persons will be invited to participate.

Treatment and study plan

Obtaining one or semen samples

Diagnostic Test

Through staining of semen samples with sets of dyes to measure features of chromatin density, nuclear morphology and mitochondrial status in large numbers of single spermatozoa and to compare differences in the staining results with known fertility outcome. Through comprehensive comparative epigenetic studies we anticipate to explain different efficiencies of sperm from men with seemingly normal semen quality in driving embryonic development.

Other names: Semen analysis

Primary outcomes

  1. Differences in chromatin density.

    Time frame: 12 months

    Staining of the nucleus of spermatozoa with the fluorescent dye chromomycin

Secondary outcomes

  1. Normal and abnormal embryo development after assisted reproduction.

    Time frame: 24 months

    Differences in distribution of epigenetic markers.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Friedrich Miescher Institute for Biomedical Research (FMI)

Registry information

Official study title

Identification and Characterization of Human Sperm Variation and Its Role in Embryonic Development.

Acronym: EPI

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Feb 5, 2020
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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