InfertilityTABAFERTIMASCNCT02803658
Impact of Male Smoking on the Couple's Infertility
A study testing smoking behavior and Sperm collection in people with Infertility, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial summary
About 15% of couples consult for difficulties achieving pregnancy. In about two-thirds of cases, a male component is identified, but is not always sufficient to explain infertility. In the majority of cases, the cause cannot be clearly identified and multiple abnormalities may be detected in both partners. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- smoking behavior and Sperm collection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Dec 2012to Oct 2018
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fertile couples = control cases (with spontaneously conceived a child with a time required to design less than 12 months) and whose wife gives birth in one of the two maternity hospitals participating in the study
- All couples candidates for AMP: reproductive age couples (Female age <35 years of age men <40 years), infertility (primary infertility, inability to conceive after 12 months of no sex protected). 1st or 2nd attempt at in vitro fertilization
- For infertile couples, couples in which we note
- spouses have sperm characteristics compatible with a natural pregnancy: an normospermie (> 20 million / ml) or moderate oligozoospermia (5-20 million sperm per ml) idiopathic (or exclusion criteria)
- where the partner does not exhibit anovulation or tubal pathology-proven utero, whose ovarian reserve is normal (FSH and estradiol rate J2 / 3 of cycle) ,.
Who cannot join
- Female age > 35 years Women> 45 years
- Co- infections of one of the two members of the couple (or 2) by HIV, HBV and / or HCV
- Severe Oligospermia humans ( <5000 000 sperm) or azzoospermie
- A normospermie or moderate oligozoospermia (5-20 million sperm per ml) nonidiopathic
- Will also be excluded couples where the partner has anovulation or uterotubal proven pathology , impaired ovarian reserve or chronic viral disease
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Impact of Male Smoking on the Couple's Infertility: Two-centre Case-control Study
About 15% of couples consult for difficulties achieving pregnancy. In about two-thirds of cases, a male component is identified, but is not always sufficient to explain infertility. In the majority of cases, the cause cannot be clearly identified and multiple abnormalities may be detected in both partners.
Many factors concerning lifestyle and environment (medications, alcohol, smoking, pollution, exposure to heat, toxins, xenobiotic oestrogens, etc.) may impact on fertility. These factors may also impact on the fertility of the children conceived, which is described as an intergenerational effect (alteration of the fertility of boys exposed to smoking in utero).
Few scientific studies with a high level of proof have been published on the impact of smoking on the couple's fertility. Gonadal functioning and the quality of gametes can be altered by these environmental factors, which may trigger a process of apoptosis or alteration of the DNA of gametes (sperm DNA fragmentation). Other modifications include DNA methylation and histone acetylation, which control gene expression and are grouped under the term epigenetic modifications. More recently, oestrogens has been shown to be involved in male reproductive function by acting on spermatogenesis, spermiogenesis and epididymal maturation. Demonstration of an active aromatase (Arom) (mRNA, protein and activity) in ejaculated human spermatozoa suggests the synthesis of small quantities of oestrogens in spermatozoa. The study of transcript profiles could provide information about the quality of spermatogenesis and/or spermiogenesis and during the first steps of embryonic development. Confocal microscopy has colocalized the aromatase on the head, midpiece and tail and can be used to assess the quality of the acrosome with anti-CD-46 monoclonal antibody. Even low concentrations of xenobiotic oestrogens can exert biological effects on certain functions of murine or human spermatozoa, accelerating capacitation and the acrosome reaction. These factors are all the more effective when they act in combination, as human gametes appear to be more sensitive to their action than murine gametes All studies conducted to date have investigated the impact of toxins either on one of the partners or in the children born to the couple. No detailed and high-level scientific study has studied both partners and the quality of their embryos.
Read the detailed description
The Amiens University Hospital Cytogenetic, CECOS Reproduction Biology, and the assisted reproductive technology departments in collaboration with Caen University Hospital (members of G4) want to conduct this type of routine clinical practice follow-up study in the context of an inter-regional research grant (PHRC). These 2 University Hospitals are situated in agricultural regions with potential polluting industries. The recruitment of these centres comprises younger couples presenting with infertility for which a cause cannot always be demonstrated and in which the percentage of ART by ICSI is higher than the national average (close to 75% vs 60%). This population also presents a higher cancer risk than in other regions.
This research project concerns evaluation of the impact of male smoking on the couple's fertility and will consist of a two-centre case-control study.
- Conditions
- Infertility
- Being tested
- smoking behavior, Sperm collection
- Keywords
- smoking
- Medical subject headings
- Infertility, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking behaviorBehavioural
Sperm collectionBiological
| Study group | Role | What they receive |
|---|---|---|
| infertile couples | Experimental | smoking behavior Receives: Behavioral: smoking behavior; Biological: Sperm collection |
| Fertile couples | Active comparator | smoking behavior Receives: Behavioral: smoking behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon monoxide
in expired air using CO-tester®
Measured: 3 months
Cotinine rate (micromol/L)
quantitative dosages of blood and / or seminal fluid or in the hair
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start5 Dec 2012
- Primary completionOct 2018
- Study completionOct 2018
Why it stopped: recruitement difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aviva DEVAUX, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803658
- Sponsor's protocol ID
- PHRCIR09-DR-DEVAUX-MME
- Acronym
- TABAFERTIMASC
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Male Smoking on the Couple's Infertility: Two-centre Case-control Study
- ClinicalTrials.gov ID
- NCT02803658
- Acronym / sponsor ID
- TABAFERTIMASC / PHRCIR09-DR-DEVAUX-MME
- Conditions
- Infertility
- Keywords
- smoking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitement difficulties
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 5 Dec 2012 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 17 Jun 2016 (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.
About 15% of couples consult for difficulties achieving pregnancy. In about two-thirds of cases, a male component is identified, but is not always sufficient to explain infertility. In the majority of cases, the cause cannot be clearly identified and multiple abnormalities may be detected in both partners.
Many factors concerning lifestyle and environment (medications, alcohol, smoking, pollution, exposure to heat, toxins, xenobiotic oestrogens, etc.) may impact on fertility. These factors may also impact on the fertility of the children conceived, which is described as an intergenerational effect (alteration of the fertility of boys exposed to smoking in utero).
Few scientific studies with a high level of proof have been published on the impact of smoking on the couple's fertility. Gonadal functioning and the quality of gametes can be altered by these environmental factors, which may trigger a process of apoptosis or alteration of the DNA of gametes (sperm DNA fragmentation). Other modifications include DNA methylation and histone acetylation, which control gene expression and are grouped under the term epigenetic modifications. More recently, oestrogens has been shown to be involved in male reproductive function by acting on spermatogenesis, spermiogenesis and epididymal maturation. Demonstration of an active aromatase (Arom) (mRNA, protein and activity) in ejaculated human spermatozoa suggests the synthesis of small quantities of oestrogens in spermatozoa. The study of transcript profiles could provide information about the quality of spermatogenesis and/or spermiogenesis and during the first steps of embryonic development. Confocal microscopy has colocalized the aromatase on the head, midpiece and tail and can be used to assess the quality of the acrosome with anti-CD-46 monoclonal antibody. Even low concentrations of xenobiotic oestrogens can exert biological effects on certain functions of murine or human spermatozoa, accelerating capacitation and the acrosome reaction. These factors are all the more effective when they act in combination, as human gametes appear to be more sensitive to their action than murine gametes All studies conducted to date have investigated the impact of toxins either on one of the partners or in the children born to the couple. No detailed and high-level scientific study has studied both partners and the quality of their embryos.
Detailed description
The Amiens University Hospital Cytogenetic, CECOS Reproduction Biology, and the assisted reproductive technology departments in collaboration with Caen University Hospital (members of G4) want to conduct this type of routine clinical practice follow-up study in the context of an inter-regional research grant (PHRC). These 2 University Hospitals are situated in agricultural regions with potential polluting industries. The recruitment of these centres comprises younger couples presenting with infertility for which a cause cannot always be demonstrated and in which the percentage of ART by ICSI is higher than the national average (close to 75% vs 60%). This population also presents a higher cancer risk than in other regions.
This research project concerns evaluation of the impact of male smoking on the couple's fertility and will consist of a two-centre case-control study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infertile couples | Experimental | Behavioral: smoking behavior, Biological: Sperm collectionsmoking behavior |
| Fertile couples | Active comparator | Behavioral: smoking behaviorsmoking behavior |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Fertile couples = control cases (with spontaneously conceived a child with a time required to design less than 12 months) and whose wife gives birth in one of the two maternity hospitals participating in the study
- All couples candidates for AMP: reproductive age couples (Female age <35 years of age men <40 years), infertility (primary infertility, inability to conceive after 12 months of no sex protected). 1st or 2nd attempt at in vitro fertilization
- For infertile couples, couples in which we note
Key exclusion criteria (5 listed)
- Female age > 35 years Women> 45 years
- Co- infections of one of the two members of the couple (or 2) by HIV, HBV and / or HCV
- Severe Oligospermia humans ( <5000 000 sperm) or azzoospermie
- A normospermie or moderate oligozoospermia (5-20 million sperm per ml) nonidiopathic
- Will also be excluded couples where the partner has anovulation or uterotubal proven pathology , impaired ovarian reserve or chronic viral disease
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 |
|---|---|---|
| smoking behavior | Behavioural | Fertile couples, infertile couples |
| Sperm collection | Biological | infertile couples |
Primary outcome
Carbon monoxide
Time frame: 3 months
in expired air using CO-tester®
Cotinine rate (micromol/L)
Time frame: 3 months
quantitative dosages of blood and / or seminal fluid or in the hair
Results and safety
The study was stopped early (reason given: recruitement difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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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.
Aviva DEVAUX, PhD principal investigator
CHU Amiens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smoking behavior and Sperm collection in people with Infertility, run by Centre Hospitalier Universitaire, Amiens 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 5 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: stopped early, as of the sponsor's last update on 12 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 was stopped early (reason given: recruitement difficulties). Results are not available in the source record.
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?
Carbon monoxide (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.