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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT01239186
Collaborator
(none)
49
1
42
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: methylation analyses on spermatozoa from infertile men

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 Design

Study Type:
Observational
Actual Enrollment :
49 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Oligozoospermia

infertile patients presenting a reduced sperm count (less than 20 Millions of spermatozoa/ml)

Other: methylation analyses on spermatozoa from infertile men
microarray analysis(www.EPIGENOMICS.com)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

  2. Estimate the association between these modifications and the nuclear quality of the sperm cell [1 day]

    by TUNEL analysis

  3. Estimate the association between these modifications and the rates of success with In VITRO fertilization [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Biology of reproduction (TENON Hospital) Paris Ile de France France 75020

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Célia Ravel, MD, TENON Hospital - APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01239186
Other Study ID Numbers:
  • AOR 08027
First Posted:
Nov 11, 2010
Last Update Posted:
Aug 7, 2013
Last Verified:
Aug 1, 2013
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 7, 2013