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Impact of Male Smoking on the Couple's Infertility (TABAFERTIMASC)

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
smoking behavior
Sperm collection
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infertility focused on measuring smoking

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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:

  • 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

Sites / Locations

  • CHU Amiens
  • CHU Caen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

infertile couples

Fertile couples

Arm Description

smoking behavior

smoking behavior

Outcomes

Primary Outcome Measures

Carbon monoxide
in expired air using CO-tester®
Cotinine rate (micromol/L)
quantitative dosages of blood and / or seminal fluid or in the hair

Secondary Outcome Measures

Full Information

First Posted
June 10, 2016
Last Updated
August 3, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02803658
Brief Title
Impact of Male Smoking on the Couple's Infertility
Acronym
TABAFERTIMASC
Official Title
Impact of Male Smoking on the Couple's Infertility: Two-centre Case-control Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2012 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
smoking

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
infertile couples
Arm Type
Experimental
Arm Description
smoking behavior
Arm Title
Fertile couples
Arm Type
Active Comparator
Arm Description
smoking behavior
Intervention Type
Behavioral
Intervention Name(s)
smoking behavior
Intervention Type
Biological
Intervention Name(s)
Sperm collection
Primary Outcome Measure Information:
Title
Carbon monoxide
Description
in expired air using CO-tester®
Time Frame
3 months
Title
Cotinine rate (micromol/L)
Description
quantitative dosages of blood and / or seminal fluid or in the hair
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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) ,. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aviva DEVAUX, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14033
Country
France

12. IPD Sharing Statement

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Impact of Male Smoking on the Couple's Infertility

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