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

Completed

• Conditions: Oligospermia
• Interventions: Other: methylation analyses on spermatozoa from infertile men

• Registration Number: NCT01239186
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Primary Completion: 2011-09
• Study Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oligozoospermia	methylation analyses on spermatozoa from infertile men	infertile patients presenting a reduced sperm count (less than 20 Millions of spermatozoa/ml)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Determine if these methylation abnormalities of the locus H19 reflect changes in the profile of global methylation of the spermatic DNA	1 day
Estimate the association between these modifications and the rates of success with In VITRO fertilization	1 day
Estimate the association between these modifications and the nuclear quality of the sperm cell	1 day	by TUNEL analysis

Trial Locations

Locations (1)

Department of Biology of reproduction (TENON Hospital); 🇫🇷 Paris, Ile de France, France