Clinical trial NCT01239186: Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men
Official title: Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oligospermia
Keywords: methylation
micro array
locus H19
male infertility
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Bring to light methylation abnormalities of the locus H19 in men's mature sperm cells presenting an unexplained oligozoospermia
timeFrame: 1 day
Secondary outcomes:
measure: Determine if these methylation abnormalities of the locus H19 reflect changes in the profile of global methylation of the spermatic DNA
timeFrame: 1 day
measure: Estimate the association between these modifications and the nuclear quality of the sperm cell
timeFrame: 1 day
measure: Estimate the association between these modifications and the rates of success with In VITRO fertilization
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Biology of reproduction (TENON Hospital)
state: Ile de France
Study officials:
affiliation: TENON Hospital - APHP
name: Célia Ravel, MD
role: PRINCIPAL_INVESTIGATOR
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