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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01239186
Acronym
METHYLHOMME
Enrollment
49
Registered
2010-11-11
Start date
2009-06-30
Completion date
2012-12-31
Last updated
2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oligospermia

Keywords

methylation, micro array, locus H19, male infertility

Brief summary

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.

Detailed description

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.

Interventions

OTHERmethylation analyses on spermatozoa from infertile men

microarray analysis(www.EPIGENOMICS.com)

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Bring to light methylation abnormalities of the locus H19 in men's mature sperm cells presenting an unexplained oligozoospermia1 day

Secondary

MeasureTime frameDescription
Determine if these methylation abnormalities of the locus H19 reflect changes in the profile of global methylation of the spermatic DNA1 day
Estimate the association between these modifications and the nuclear quality of the sperm cell1 dayby TUNEL analysis
Estimate the association between these modifications and the rates of success with In VITRO fertilization1 day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026