CClinicalTrials.gg
TerminatedNCT02803658TABAFERTIMASCUpdated Jun 12, 2026

Impact of Male Smoking on the Couple's Infertility

An interventional study of smoking behavior and Sperm collection in Infertility, sponsored by Centre Hospitalier Universitaire, Amiens. Terminated at 2 sites in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Basic science

Why this study was terminated
recruitement difficulties

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Dec 2012, registered Jun 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Infertility

Keywords

  • smoking
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 154 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

    1. 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)
    2. 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) ,.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    infertile couples

    smoking behavior

    Behavioral: smoking behavior · Biological: Sperm collection

  • Active comparator
    Fertile couples

    smoking behavior

    Behavioral: smoking behavior

Interventions

  • Behavioralsmoking behavior
  • BiologicalSperm collection
06

What researchers measure

Primary outcomes

  1. Carbon monoxide

    in expired air using CO-tester®

    Time frame: 3 months

  2. Cotinine rate (micromol/L)

    quantitative dosages of blood and / or seminal fluid or in the hair

    Time frame: 3 months

07

Study locations

2 sites
  • CHU Amiens
    Amiens, 80054, France
  • CHU Caen
    Caen, 14033, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02803658
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jun 17, 2016
Start date
Dec 5, 2012
Primary completion
Oct 2018
Completion
Oct 2018
Last update
Jun 12, 2026

Study contacts

Aviva DEVAUX, PhD
principal investigator · CHU Amiens
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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