Impact of Male Smoking on the Couple's Infertility

NCT02803658 | Terminated

• 1 other identifier: PHRCIR09-DR-DEVAUX-MME
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Infertility

Keywords

smoking

Outcome Measures

Primary Outcomes (2)

• Carbon monoxide

  in expired air using CO-tester®

  3 months

• Cotinine rate (micromol/L)

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

  3 months

Study Arms (2)

infertile couples

EXPERIMENTAL

smoking behavior

Behavioral: smoking behavior; Biological: Sperm collection

Fertile couples

ACTIVE COMPARATOR

smoking behavior

Behavioral: smoking behavior

Interventions

smoking behavior BEHAVIORAL

Fertile couples; infertile couples

Sperm collection BIOLOGICAL

infertile couples

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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) ,.
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (2)

CHU Amiens

Amiens, 80054, France

Location

CHU Caen

Caen, 14033, France

Location

MeSH Terms

Conditions

Infertility; Smoking

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Behavior

Study Officials

• Aviva DEVAUX, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 17, 2016
• Study Start: December 5, 2012
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

FR (2)