NCT01239186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

2.3 years

First QC Date

October 22, 2010

Last Update Submit

August 6, 2013

Conditions

Oligospermia

Keywords

methylationmicro arraylocus H19male infertility

Outcome Measures

Primary Outcomes (1)

  • Bring to light methylation abnormalities of the locus H19 in men's mature sperm cells presenting an unexplained oligozoospermia

    1 day

Secondary Outcomes (3)

  • 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 nuclear quality of the sperm cell

    1 day

  • Estimate the association between these modifications and the rates of success with In VITRO fertilization

    1 day

Study Arms (1)

Oligozoospermia

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

Other: methylation analyses on spermatozoa from infertile men

Interventions

methylation analyses on spermatozoa from infertile menOTHER

microarray analysis(www.EPIGENOMICS.com)

Oligozoospermia

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biology of reproduction (TENON Hospital)

Paris, Île-de-France Region, 75020, France

Location

Related Publications (13)

  • Adami HO, Bergstrom R, Mohner M, Zatonski W, Storm H, Ekbom A, Tretli S, Teppo L, Ziegler H, Rahu M, et al. Testicular cancer in nine northern European countries. Int J Cancer. 1994 Oct 1;59(1):33-8. doi: 10.1002/ijc.2910590108.

    PMID: 7927900BACKGROUND

  • Anway MD, Cupp AS, Uzumcu M, Skinner MK. Epigenetic transgenerational actions of endocrine disruptors and male fertility. Science. 2005 Jun 3;308(5727):1466-9. doi: 10.1126/science.1108190.

    PMID: 15933200BACKGROUND

  • Auger J, Kunstmann JM, Czyglik F, Jouannet P. Decline in semen quality among fertile men in Paris during the past 20 years. N Engl J Med. 1995 Feb 2;332(5):281-5. doi: 10.1056/NEJM199502023320501.

    PMID: 7816062BACKGROUND

  • Carlsen E, Giwercman A, Keiding N, Skakkebaek NE. Evidence for decreasing quality of semen during past 50 years. BMJ. 1992 Sep 12;305(6854):609-13. doi: 10.1136/bmj.305.6854.609.

    PMID: 1393072BACKGROUND

  • Davis TL, Yang GJ, McCarrey JR, Bartolomei MS. The H19 methylation imprint is erased and re-established differentially on the parental alleles during male germ cell development. Hum Mol Genet. 2000 Nov 22;9(19):2885-94. doi: 10.1093/hmg/9.19.2885.

    PMID: 11092765BACKGROUND

  • Gicquel C, Gaston V, Mandelbaum J, Siffroi JP, Flahault A, Le Bouc Y. In vitro fertilization may increase the risk of Beckwith-Wiedemann syndrome related to the abnormal imprinting of the KCN1OT gene. Am J Hum Genet. 2003 May;72(5):1338-41. doi: 10.1086/374824. No abstract available.

    PMID: 12772698BACKGROUND

  • Hartmann S, Bergmann M, Bohle RM, Weidner W, Steger K. Genetic imprinting during impaired spermatogenesis. Mol Hum Reprod. 2006 Jun;12(6):407-11. doi: 10.1093/molehr/gal040. Epub 2006 Apr 11.

    PMID: 16608903BACKGROUND

  • Kaiser J. Developmental biology. Endocrine disrupters trigger fertility problems in multiple generations. Science. 2005 Jun 3;308(5727):1391-2. doi: 10.1126/science.308.5727.1391a. No abstract available.

    PMID: 15933166BACKGROUND

  • Kobayashi H, Sato A, Otsu E, Hiura H, Tomatsu C, Utsunomiya T, Sasaki H, Yaegashi N, Arima T. Aberrant DNA methylation of imprinted loci in sperm from oligospermic patients. Hum Mol Genet. 2007 Nov 1;16(21):2542-51. doi: 10.1093/hmg/ddm187. Epub 2007 Jul 17.

    PMID: 17636251BACKGROUND

  • Paulozzi LJ, Erickson JD, Jackson RJ. Hypospadias trends in two US surveillance systems. Pediatrics. 1997 Nov;100(5):831-4. doi: 10.1542/peds.100.5.831.

    PMID: 9346983BACKGROUND

  • Preiksa RT, Zilaitiene B, Matulevicius V, Skakkebaek NE, Petersen JH, Jorgensen N, Toppari J. Higher than expected prevalence of congenital cryptorchidism in Lithuania: a study of 1204 boys at birth and 1 year follow-up. Hum Reprod. 2005 Jul;20(7):1928-32. doi: 10.1093/humrep/deh887. Epub 2005 Apr 28.

    PMID: 15860495BACKGROUND

  • Skakkebaek NE, Rajpert-De Meyts E, Main KM. Testicular dysgenesis syndrome: an increasingly common developmental disorder with environmental aspects. Hum Reprod. 2001 May;16(5):972-8. doi: 10.1093/humrep/16.5.972.

    PMID: 11331648BACKGROUND

  • Toppari J, Larsen JC, Christiansen P, Giwercman A, Grandjean P, Guillette LJ Jr, Jegou B, Jensen TK, Jouannet P, Keiding N, Leffers H, McLachlan JA, Meyer O, Muller J, Rajpert-De Meyts E, Scheike T, Sharpe R, Sumpter J, Skakkebaek NE. Male reproductive health and environmental xenoestrogens. Environ Health Perspect. 1996 Aug;104 Suppl 4(Suppl 4):741-803. doi: 10.1289/ehp.96104s4741.

    PMID: 8880001BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Sample of sperm collected by automasturbation

MeSH Terms

Conditions

OligospermiaInfertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Célia Ravel, MD

    TENON Hospital - APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2010

First Posted

November 11, 2010

Study Start

June 1, 2009

Primary Completion

September 1, 2011

Study Completion

December 1, 2012

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

FR(1)