OligospermiaMETHYLHOMMENCT01239186

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

An observational study of Oligospermia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, men only
Conditions the study is for: Oligospermia
What is being tested?: methylation analyses on spermatozoa from infertile men
How many people: 49 participants
Where: 1 siteFrance
Study dates: Jun 2009to Dec 2012
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
No healthy volunteers
Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

Department of Biology of reproduction (TENON Hospital)
Paris, Île-de-France Region, 75020

Other trials in France

About this study

Read the 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.

Conditions: Oligospermia
Being tested: methylation analyses on spermatozoa from infertile men
Keywords: methylation, micro array, locus H19, male infertility
Medical subject headings: Oligospermia, Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

methylation analyses on spermatozoa from infertile menOther
microarray analysis(www.EPIGENOMICS.com)

Study groups in NCT01239186
Study group	Role	What they receive
Oligozoospermia		infertile patients presenting a reduced sperm count (less than 20 Millions of spermatozoa/ml) Receives: Other: methylation analyses on spermatozoa from infertile men

What is being measured

The primary outcome is the main question the study is designed to answer.

Bring to light methylation abnormalities of the locus H19 in men's mature sperm cells presenting an unexplained oligozoospermia
Measured: 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
Measured: 1 day
Estimate the association between these modifications and the nuclear quality of the sperm cell
by TUNEL analysis
Measured: 1 day
Estimate the association between these modifications and the rates of success with In VITRO fertilization
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Dec 2012

First posted11 Nov 2010 (estimated)
Study startJun 2009
Primary completionSep 2011
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for OligospermiaStudies of the same condition, open and under way.
More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01239186
Sponsor's protocol ID: AOR 08027
Acronym: METHYLHOMME
Status last verified: Aug 2013
First submitted: 22 Oct 2010
Last updated: 7 Aug 2013
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 7927900
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.
PubMed 15933200
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.
PubMed 7816062
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.
PubMed 1393072
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.
PubMed 11092765
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.
PubMed 12772698
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.
PubMed 16608903
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.
PubMed 15933166
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.
PubMed 17636251
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.
PubMed 9346983
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.
PubMed 15860495
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.
PubMed 11331648
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.
PubMed 8880001

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Oligospermia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men
ClinicalTrials.gov ID: NCT01239186
Acronym / sponsor ID: METHYLHOMME / AOR 08027
Conditions: Oligospermia
Keywords: methylation, micro array, locus H19, male infertility
Study type: Observational
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Study start: Jun 2009
Primary completion: Sep 2011 (actual)
Study completion: Dec 2012 (actual)
First posted: 11 Nov 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The patients will realize a taking of sperm having signed the consent.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Oligozoospermia	–	Other: methylation analyses on spermatozoa from infertile meninfertile patients presenting a reduced sperm count (less than 20 Millions of spermatozoa/ml)

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult
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

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
methylation analyses on spermatozoa from infertile menmicroarray analysis(www.EPIGENOMICS.com)	Other	Oligozoospermia

Primary outcome

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

3 secondary outcomes

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
Estimate the association between these modifications and the nuclear quality of the sperm cell
Time frame: 1 day
Estimate the association between these modifications and the rates of success with In VITRO fertilization
Time frame: 1 day

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
Background: PubMed 7927900Adami 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.
Background: PubMed 15933200Anway 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.
Background: PubMed 7816062Auger 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.
Background: PubMed 1393072Carlsen 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.
Background: PubMed 11092765Davis 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.
Background: PubMed 12772698Gicquel 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.
Background: PubMed 16608903Hartmann 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.
Background: PubMed 15933166Kaiser 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.
Background: PubMed 17636251Kobayashi 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.
Background: PubMed 9346983Paulozzi 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.
Background: PubMed 15860495Preiksa 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.
Background: PubMed 11331648Skakkebaek 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.

Related trials for Oligospermia

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Sperm, Exposure and Endocrine Disruptors
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Not yet recruitingPhase 4
Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial
Oligoasthenoteratozoospermia, Male Infertility
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Célia Ravel, MD principal investigator

TENON Hospital - APHP

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Oligospermia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bring to light methylation abnormalities of the locus H19 in men's mature sperm cells presenting an unexplained oligozoospermia (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01239186, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.