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Completed

NCT Number: NCT01239186

Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men

This study will analyse the sperm global methylation status of 62 infertile men before assisted reproductive techniques. Some of these patients (20%) present hypomethylation of H19 locus. A global methylation analysis may reveal others imprinting defects.

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Key information

Conditions

Oligospermia Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Biology of reproduction (TENON Hospital)

Paris, Île-de-France Region, 75020, France

About this study

An increase of the abnormalities of the imprint was brought back at the child's stemming from assisted reproductive techniques. Now abnormalities of methylation could be implied in defects of spermatogenesis and certain abnormalities of development of the male germ cells could be due to modifications abnormal epigenetics.

The objective of this research is to determine the frequency of arisen the abnormalities of methylation at the level of the locus H19 in the sperm cells of barren men presenting an unexplained oligozoospermia and to determine if these changes are a reflection of abnormalities of the profiles of methylation of the whole genome.

The patients will realize a taking of sperm having signed the consent.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men from 18 to 45 years old, presenting an idiopathic oligozoospermia lower than 10 million sperm cells / ml and include in a program of medically assisted conception
  • Patients with social security
  • Patients having signed the informed consent

Exclusion criteria

  • Infertility with a neoplastic origin: patients subjected to a treatment potentially sterilizing (chemotherapy or radiotherapy).
  • Infertility with an infectious origin
  • Infertility with a traumatic origin
  • Infertility bound to a chromosomal abnormality or a microdeletion of Y
  • Histories of cryptorchidism, of varicocele

Treatment and study plan

methylation analyses on spermatozoa from infertile men

Other

microarray analysis(www.EPIGENOMICS.com)

Primary outcomes

  1. Bring to light methylation abnormalities of the locus H19 in men's mature sperm cells presenting an unexplained oligozoospermia

    Time frame: 1 day

Secondary outcomes

  1. Determine if these methylation abnormalities of the locus H19 reflect changes in the profile of global methylation of the spermatic DNA

    Time frame: 1 day

  2. Estimate the association between these modifications and the nuclear quality of the sperm cell

    Time frame: 1 day

    by TUNEL analysis

  3. Estimate the association between these modifications and the rates of success with In VITRO fertilization

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: METHYLHOMME

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Nov 11, 2010
Registry last updated
Aug 7, 2013

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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