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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01239186
First received: October 22, 2010
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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 Intervention
Oligospermia
Other: methylation analyses on spermatozoa from infertile men

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Bring to light methylation abnormalities of the locus H19 in men's mature sperm cells presenting an unexplained oligozoospermia [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Estimate the association between these modifications and the nuclear quality of the sperm cell [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    by TUNEL analysis

  • Estimate the association between these modifications and the rates of success with In VITRO fertilization [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Sample of sperm collected by automasturbation


Enrollment: 49
Study Start Date: June 2009
Study Completion Date: December 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239186

Locations
France
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
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01239186     History of Changes
Other Study ID Numbers: AOR 08027
Study First Received: October 22, 2010
Last Updated: August 6, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Assistance Publique - Hôpitaux de Paris:
methylation
micro array
locus H19
male infertility

Additional relevant MeSH terms:
Congenital Abnormalities
Oligospermia
Infertility, Male
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on August 28, 2014