Male InfertilityVATESNCT02006446
Relationship Between Sperm Head Vacuoles and Sperm DNA Alterations in Infertile Men
A study testing Sperm Samples in people with Male Infertility, run by University Hospital, Rouen at 2 sites in France.
Trial summary
In men presenting sperm alterations, the selection of genetically undamaged spermatozoa need to be improved in order to increase the success of assisted reproduction treatments. The aim of this study is to determine whether the presence of sperm head vacuoles is associated with sperm DNA alterations. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- Sperm Samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2013to Jan 2017
- Phase
- Interventional
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men
- 18 years old or more
- affiliated to social security
- with isolated teratozoospermia or oligo-astheno-teratozoospermia according to the WHO guidelines (2010):
- sperm concentration < 15 million per ml or sperm number < 39 million per ejaculate
- progressive motility < 35%
Show all 10Show fewer
- morphologically normal forms < 50% according to the modified David's classification (Auger et al., 2001
- mobile spermatozoa selected by density gradient centrifugation > 1 million, in previous spermograms
- with normal constitutional karyotypes (46, XY)
- signed an informed consent
Who cannot join
- with abnormal constitutional karyotypes
- with a major alteration of sperm parameters, with mobile spermatozoa selected by density gradient centrifugation < 1 million
- under tutorship or guardianship by court order
Trial locations and contacts
2 sites in 1 country.
France2 sites
Laboratoire de spermiologie, Hôpital Calmette, CHRU de Lille
Lille
Laboratoire de Biologie de la Reproduction - CECOS - EA 4308, CHU - Hôpitaux de Rouen
Rouen, 76031
About this study
Official title: Are Sperm Head Vacuoles Associated With Sperm Nuclear Alterations?
In men presenting sperm alterations, the selection of genetically undamaged spermatozoa need to be improved in order to increase the success of assisted reproduction treatments.
The aim of this study is to determine whether the presence of sperm head vacuoles is associated with sperm DNA alterations.
Read the detailed description
The use of intracytoplasmic sperm injection (ICSI) has greatly improved the treatment of severe male infertility, especially for men with oligo-astheno-teratozoospermia (OAT). This in vitro fertilization procedure allows the direct injection of a single spermatozoon into an oocyte. The sperm used for ICSI is selected under a microscope at a 400x magnification. Several studies have reported that de novo chromosomal abnormalities are increased in children born from ICSI , thereby raising the question of the genetic quality of spermatozoa used for ICSI.
A method called MSOME (high magnification Motile Sperm Organelle Morphology Examination), which allows the detailed morphological evaluation of motile spermatozoa in real time and under high magnification (6600x), was developed in 2001. With this technique, fine morphological abnormalities - mainly vacuoles in the head of spermatozoa - were detected. The use of MSOME for the detection of morphologically normal sperm for ICSI gave rise to a technique called IMSI (Intracytoplasmic Morphologically Selected sperm Injection). Higher pregnancy rates were obtained with IMSI compared to ICSI and sperm head vacuoles were found to negatively affect assisted reproduction success rates and embryo development. The use of IMSI also decreases the risk of sex chromosome aneuploidy in embryos .
Several authors found that the presence of large vacuoles in the sperm head correlates with several nuclear alterations: DNA fragmentation , abnormal chromatin condensation and aneuploidy . However, these studies are controversial and were performed on few spermatozoa. In order to improve the selection of spermatozoa with a normal chromosomal content, it is essential not only to confirm the existence of a relationship between sperm head vacuoles and altered sperm nuclear quality but also to better characterize these alterations.
The main goal of this study is to investigate the correlation between sperm head vacuole areas and sperm aneuploidy rates in men with isolated teratozoospermia or OAT. Vacuole areas will be measured by MSOME and aneuploidy rates by FISH for chromosomes 18, X and Y. Moreover, the correlation between sperm head vacuole areas and other nuclear alterations (DNA fragmentation, abnormal chromatin condensation, telomere abnormalities) will be evaluated. Semen samples from 200 patients recruited over a 2-year period will be collected, stored and analyzed.
This study involves the collection of relevant medical information. The computer website for the patient database is secure and protected by a password. The information will be entered and only be viewed by the investigators. On-site monitoring visits will be conducted throughout the study.
- Conditions
- Male Infertility
- Being tested
- Sperm Samples
- Keywords
- Male infertility, sperm head vacuoles, sperm morphology, aneuploidy, DNA fragmentation, abnormal chromatin condensation, telomere abnormalities
- Medical subject headings
- Infertility, Male, Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm SamplesOther
The study will focus on sperm samples collected via masturbation for routine pre-IVF screening tests, taken from patients with isolated teratozoospermia or oligoasthenozoospermia. The various tests and analyses planned will be carried out on sperm not used for IVF or diagnostic purposes.
| Study group | Role | What they receive |
|---|---|---|
| Altered spermograms | Experimental | Men with altered spermograms (isolated teratozoospermia or oligo-astheno-teratozoospermia) Receives: Other: Sperm Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between mean vacuole areas in sperm heads (measured by MSOME) and sperm aneuploidy rates for chromosomes X, Y and 18 (evaluated by FISH)
Measured: up to 30 months
Secondary outcomes (7)
Total sperm count
Measured: 1 day
Percentage of mobile spermatozoa
Measured: 1 day
Percentage of morphologically abnormal spermatozoa
Measured: 1 day
Mean vacuole area threshold (measured with Receiver Operating Characteristic curves)
Measured: up to 30 months
Correlation coefficient between vacuole areas and sperm DNA fragmentation (evaluated by TUNEL analysis)
Measured: up to 30 months
Correlation coefficient between vacuole areas and abnormal chromatin condensation (evaluated by aniline blue staining)
Measured: up to 30 months
Correlation coefficient between vacuole areas and telomere number, distribution and length (evaluated by quantitative FISH)
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Rives, MD., PhD., Principal investigator, Laboratoire de Biologie de la Reproduction - CECOS - EA 4308, CHU - Hôpitaux de Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006446
- Sponsor's protocol ID
- 2013/005/HP
- Acronym
- VATES
- Status last verified
- Jan 2017
- First submitted
- 25 Nov 2013
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Antinori M, Licata E, Dani G, Cerusico F, Versaci C, d'Angelo D, Antinori S. Intracytoplasmic morphologically selected sperm injection: a prospective randomized trial. Reprod Biomed Online. 2008 Jun;16(6):835-41. doi: 10.1016/s1472-6483(10)60150-2.
PubMed 18549694Auger J, Eustache F, Andersen AG, Irvine DS, Jorgensen N, Skakkebaek NE, Suominen J, Toppari J, Vierula M, Jouannet P. Sperm morphological defects related to environment, lifestyle and medical history of 1001 male partners of pregnant women from four European cities. Hum Reprod. 2001 Dec;16(12):2710-7. doi: 10.1093/humrep/16.12.2710.
PubMed 11726600Bartoov B, Berkovitz A, Eltes F. Selection of spermatozoa with normal nuclei to improve the pregnancy rate with intracytoplasmic sperm injection. N Engl J Med. 2001 Oct 4;345(14):1067-8. doi: 10.1056/NEJM200110043451416. No abstract available.
PubMed 11586970Bartoov B, Berkovitz A, Eltes F, Kogosovsky A, Yagoda A, Lederman H, Artzi S, Gross M, Barak Y. Pregnancy rates are higher with intracytoplasmic morphologically selected sperm injection than with conventional intracytoplasmic injection. Fertil Steril. 2003 Dec;80(6):1413-9. doi: 10.1016/j.fertnstert.2003.05.016.
PubMed 14667877Boitrelle F, Ferfouri F, Petit JM, Segretain D, Tourain C, Bergere M, Bailly M, Vialard F, Albert M, Selva J. Large human sperm vacuoles observed in motile spermatozoa under high magnification: nuclear thumbprints linked to failure of chromatin condensation. Hum Reprod. 2011 Jul;26(7):1650-8. doi: 10.1093/humrep/der129. Epub 2011 May 2.
PubMed 21536591Bonduelle M, Van Assche E, Joris H, Keymolen K, Devroey P, Van Steirteghem A, Liebaers I. Prenatal testing in ICSI pregnancies: incidence of chromosomal anomalies in 1586 karyotypes and relation to sperm parameters. Hum Reprod. 2002 Oct;17(10):2600-14. doi: 10.1093/humrep/17.10.2600.
PubMed 12351536Figueira Rde C, Braga DP, Setti AS, Iaconelli A Jr, Borges E Jr. Morphological nuclear integrity of sperm cells is associated with preimplantation genetic aneuploidy screening cycle outcomes. Fertil Steril. 2011 Mar 1;95(3):990-3. doi: 10.1016/j.fertnstert.2010.11.018. Epub 2010 Dec 4.
PubMed 21130987Foresta C, Garolla A, Bartoloni L, Bettella A, Ferlin A. Genetic abnormalities among severely oligospermic men who are candidates for intracytoplasmic sperm injection. J Clin Endocrinol Metab. 2005 Jan;90(1):152-6. doi: 10.1210/jc.2004-1469. Epub 2004 Oct 27.
PubMed 15509635Franco JG Jr, Baruffi RL, Mauri AL, Petersen CG, Oliveira JB, Vagnini L. Significance of large nuclear vacuoles in human spermatozoa: implications for ICSI. Reprod Biomed Online. 2008 Jul;17(1):42-5. doi: 10.1016/s1472-6483(10)60291-x.
PubMed 18616888Franco JG Jr, Mauri AL, Petersen CG, Massaro FC, Silva LF, Felipe V, Cavagna M, Pontes A, Baruffi RL, Oliveira JB, Vagnini LD. Large nuclear vacuoles are indicative of abnormal chromatin packaging in human spermatozoa. Int J Androl. 2012 Feb;35(1):46-51. doi: 10.1111/j.1365-2605.2011.01154.x. Epub 2011 Apr 28.
PubMed 21535011Garolla A, Fortini D, Menegazzo M, De Toni L, Nicoletti V, Moretti A, Selice R, Engl B, Foresta C. High-power microscopy for selecting spermatozoa for ICSI by physiological status. Reprod Biomed Online. 2008 Nov;17(5):610-6. doi: 10.1016/s1472-6483(10)60307-0.
PubMed 18983744Hazout A, Dumont-Hassan M, Junca AM, Cohen Bacrie P, Tesarik J. High-magnification ICSI overcomes paternal effect resistant to conventional ICSI. Reprod Biomed Online. 2006 Jan;12(1):19-25. doi: 10.1016/s1472-6483(10)60975-3.
PubMed 16454928Oliveira JB, Massaro FC, Baruffi RL, Mauri AL, Petersen CG, Silva LF, Vagnini LD, Franco JG Jr. Correlation between semen analysis by motile sperm organelle morphology examination and sperm DNA damage. Fertil Steril. 2010 Oct;94(5):1937-40. doi: 10.1016/j.fertnstert.2010.01.042. Epub 2010 Mar 2.
PubMed 20189558Perdrix A, Travers A, Chelli MH, Escalier D, Do Rego JL, Milazzo JP, Mousset-Simeon N, Mace B, Rives N. Assessment of acrosome and nuclear abnormalities in human spermatozoa with large vacuoles. Hum Reprod. 2011 Jan;26(1):47-58. doi: 10.1093/humrep/deq297. Epub 2010 Nov 18.
PubMed 21088015Van Steirteghem A, Bonduelle M, Devroey P, Liebaers I. Follow-up of children born after ICSI. Hum Reprod Update. 2002 Mar-Apr;8(2):111-6. doi: 10.1093/humupd/8.2.111.
PubMed 12099626
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Sperm Head Vacuoles Associated With Sperm Nuclear Alterations?
- ClinicalTrials.gov ID
- NCT02006446
- Acronym / sponsor ID
- VATES / 2013/005/HP
- Conditions
- Male Infertility
- Keywords
- Male infertility, sperm head vacuoles, sperm morphology, aneuploidy, DNA fragmentation, abnormal chromatin condensation, telomere abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 Dec 2013 (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.
In men presenting sperm alterations, the selection of genetically undamaged spermatozoa need to be improved in order to increase the success of assisted reproduction treatments.
The aim of this study is to determine whether the presence of sperm head vacuoles is associated with sperm DNA alterations.
Detailed description
The use of intracytoplasmic sperm injection (ICSI) has greatly improved the treatment of severe male infertility, especially for men with oligo-astheno-teratozoospermia (OAT). This in vitro fertilization procedure allows the direct injection of a single spermatozoon into an oocyte. The sperm used for ICSI is selected under a microscope at a 400x magnification. Several studies have reported that de novo chromosomal abnormalities are increased in children born from ICSI , thereby raising the question of the genetic quality of spermatozoa used for ICSI.
A method called MSOME (high magnification Motile Sperm Organelle Morphology Examination), which allows the detailed morphological evaluation of motile spermatozoa in real time and under high magnification (6600x), was developed in 2001. With this technique, fine morphological abnormalities - mainly vacuoles in the head of spermatozoa - were detected. The use of MSOME for the detection of morphologically normal sperm for ICSI gave rise to a technique called IMSI (Intracytoplasmic Morphologically Selected sperm Injection). Higher pregnancy rates were obtained with IMSI compared to ICSI and sperm head vacuoles were found to negatively affect assisted reproduction success rates and embryo development. The use of IMSI also decreases the risk of sex chromosome aneuploidy in embryos .
Several authors found that the presence of large vacuoles in the sperm head correlates with several nuclear alterations: DNA fragmentation , abnormal chromatin condensation and aneuploidy . However, these studies are controversial and were performed on few spermatozoa. In order to improve the selection of spermatozoa with a normal chromosomal content, it is essential not only to confirm the existence of a relationship between sperm head vacuoles and altered sperm nuclear quality but also to better characterize these alterations.
The main goal of this study is to investigate the correlation between sperm head vacuole areas and sperm aneuploidy rates in men with isolated teratozoospermia or OAT. Vacuole areas will be measured by MSOME and aneuploidy rates by FISH for chromosomes 18, X and Y. Moreover, the correlation between sperm head vacuole areas and other nuclear alterations (DNA fragmentation, abnormal chromatin condensation, telomere abnormalities) will be evaluated. Semen samples from 200 patients recruited over a 2-year period will be collected, stored and analyzed.
This study involves the collection of relevant medical information. The computer website for the patient database is secure and protected by a password. The information will be entered and only be viewed by the investigators. On-site monitoring visits will be conducted throughout the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Altered spermograms | Experimental | Other: Sperm SamplesMen with altered spermograms (isolated teratozoospermia or oligo-astheno-teratozoospermia) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- men
- 18 years old or more
- affiliated to social security
- with isolated teratozoospermia or oligo-astheno-teratozoospermia according to the WHO guidelines (2010):
- with normal constitutional karyotypes (46, XY)
Key exclusion criteria (3 listed)
- with abnormal constitutional karyotypes
- with a major alteration of sperm parameters, with mobile spermatozoa selected by density gradient centrifugation < 1 million
- under tutorship or guardianship by court order
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 |
|---|---|---|
| Sperm SamplesThe study will focus on sperm samples collected via masturbation for routine pre-IVF screening tests, taken from patients with isolated teratozoospermia or oligoasthenozoospermia. The various tests and analyses planned will be carried out on sperm not used for IVF or diagnostic purposes. | Other | Altered spermograms |
Primary outcome
Correlation coefficient between mean vacuole areas in sperm heads (measured by MSOME) and sperm aneuploidy rates for chromosomes X, Y and 18 (evaluated by FISH)
Time frame: up to 30 months
7 secondary outcomes
Total sperm count
Time frame: 1 day
Percentage of mobile spermatozoa
Time frame: 1 day
Percentage of morphologically abnormal spermatozoa
Time frame: 1 day
Mean vacuole area threshold (measured with Receiver Operating Characteristic curves)
Time frame: up to 30 months
Correlation coefficient between vacuole areas and sperm DNA fragmentation (evaluated by TUNEL analysis)
Time frame: up to 30 months
Correlation coefficient between vacuole areas and abnormal chromatin condensation (evaluated by aniline blue staining)
Time frame: up to 30 months
Correlation coefficient between vacuole areas and telomere number, distribution and length (evaluated by quantitative FISH)
Time frame: up to 30 months
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 10 Jun 2026.
- Background: PubMed 18549694Antinori M, Licata E, Dani G, Cerusico F, Versaci C, d'Angelo D, Antinori S. Intracytoplasmic morphologically selected sperm injection: a prospective randomized trial. Reprod Biomed Online. 2008 Jun;16(6):835-41. doi: 10.1016/s1472-6483(10)60150-2.
- Background: PubMed 11726600Auger J, Eustache F, Andersen AG, Irvine DS, Jorgensen N, Skakkebaek NE, Suominen J, Toppari J, Vierula M, Jouannet P. Sperm morphological defects related to environment, lifestyle and medical history of 1001 male partners of pregnant women from four European cities. Hum Reprod. 2001 Dec;16(12):2710-7. doi: 10.1093/humrep/16.12.2710.
- Background: PubMed 11586970Bartoov B, Berkovitz A, Eltes F. Selection of spermatozoa with normal nuclei to improve the pregnancy rate with intracytoplasmic sperm injection. N Engl J Med. 2001 Oct 4;345(14):1067-8. doi: 10.1056/NEJM200110043451416. No abstract available.
- Background: PubMed 14667877Bartoov B, Berkovitz A, Eltes F, Kogosovsky A, Yagoda A, Lederman H, Artzi S, Gross M, Barak Y. Pregnancy rates are higher with intracytoplasmic morphologically selected sperm injection than with conventional intracytoplasmic injection. Fertil Steril. 2003 Dec;80(6):1413-9. doi: 10.1016/j.fertnstert.2003.05.016.
- Background: PubMed 21536591Boitrelle F, Ferfouri F, Petit JM, Segretain D, Tourain C, Bergere M, Bailly M, Vialard F, Albert M, Selva J. Large human sperm vacuoles observed in motile spermatozoa under high magnification: nuclear thumbprints linked to failure of chromatin condensation. Hum Reprod. 2011 Jul;26(7):1650-8. doi: 10.1093/humrep/der129. Epub 2011 May 2.
- Background: PubMed 12351536Bonduelle M, Van Assche E, Joris H, Keymolen K, Devroey P, Van Steirteghem A, Liebaers I. Prenatal testing in ICSI pregnancies: incidence of chromosomal anomalies in 1586 karyotypes and relation to sperm parameters. Hum Reprod. 2002 Oct;17(10):2600-14. doi: 10.1093/humrep/17.10.2600.
- Background: PubMed 21130987Figueira Rde C, Braga DP, Setti AS, Iaconelli A Jr, Borges E Jr. Morphological nuclear integrity of sperm cells is associated with preimplantation genetic aneuploidy screening cycle outcomes. Fertil Steril. 2011 Mar 1;95(3):990-3. doi: 10.1016/j.fertnstert.2010.11.018. Epub 2010 Dec 4.
- Background: PubMed 15509635Foresta C, Garolla A, Bartoloni L, Bettella A, Ferlin A. Genetic abnormalities among severely oligospermic men who are candidates for intracytoplasmic sperm injection. J Clin Endocrinol Metab. 2005 Jan;90(1):152-6. doi: 10.1210/jc.2004-1469. Epub 2004 Oct 27.
- Background: PubMed 18616888Franco JG Jr, Baruffi RL, Mauri AL, Petersen CG, Oliveira JB, Vagnini L. Significance of large nuclear vacuoles in human spermatozoa: implications for ICSI. Reprod Biomed Online. 2008 Jul;17(1):42-5. doi: 10.1016/s1472-6483(10)60291-x.
- Background: PubMed 21535011Franco JG Jr, Mauri AL, Petersen CG, Massaro FC, Silva LF, Felipe V, Cavagna M, Pontes A, Baruffi RL, Oliveira JB, Vagnini LD. Large nuclear vacuoles are indicative of abnormal chromatin packaging in human spermatozoa. Int J Androl. 2012 Feb;35(1):46-51. doi: 10.1111/j.1365-2605.2011.01154.x. Epub 2011 Apr 28.
- Background: PubMed 18983744Garolla A, Fortini D, Menegazzo M, De Toni L, Nicoletti V, Moretti A, Selice R, Engl B, Foresta C. High-power microscopy for selecting spermatozoa for ICSI by physiological status. Reprod Biomed Online. 2008 Nov;17(5):610-6. doi: 10.1016/s1472-6483(10)60307-0.
- Background: PubMed 16454928Hazout A, Dumont-Hassan M, Junca AM, Cohen Bacrie P, Tesarik J. High-magnification ICSI overcomes paternal effect resistant to conventional ICSI. Reprod Biomed Online. 2006 Jan;12(1):19-25. doi: 10.1016/s1472-6483(10)60975-3.
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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.
Nathalie Rives, MD., PhD. principal investigator
Laboratoire de Biologie de la Reproduction - CECOS - EA 4308, CHU - Hôpitaux de Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sperm Samples in people with Male Infertility, run by University Hospital, Rouen at 2 sites 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 10 inclusion and 3 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Correlation coefficient between mean vacuole areas in sperm heads (measured by MSOME) and sperm aneuploidy rates for chromosomes X, Y and 18 (evaluated by FISH) (time frame: up to 30 months). 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 NCT02006446, which also lists 18 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 10 Jun 2026.