Ignite Creation Date:
2024-05-06 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03414567
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2018-01-23
Brief Title:
Presence of Toxins From Smoking in the Follicular Fluid of Women Undergoing Intracytoplasmic Sperm Injection Treatment
Sponsor:
Infertility Treatment Center Dortmund
Organization:
Infertility Treatment Center Dortmund
Study Overview
Official Title:
Presence of Toxins From Smoking in the Follicular Fluid of Women With the Desire to Have Children Undergoing Intracytoplasmic Sperm Injection Treatment
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Smoking is associated with many adverse health effects like circulatory disorders pulmonary diseases or heart diseases It was also shown that smoking correlates with a significantly higher risk for miscarriage preterm birth or a significantly decreased implantation rate or life birth rate thus affects the chance to have children
Combustion of tobacco products results in more than 4000 toxic andor carcinogenic substances Examples of such substances are the carcinogenic substance Benzoapyrene or nicotine and its main degradation product cotinine Although the adverse effects of these substances were analyzed in many biological systems eg cell culture mouse model systems less is known about the bio-accumulation in human tissue especially in ovarian tissue or the follicular fluid FF
The aim of this study is therefore to analyze the bio-accumulation of nicotine cotinine and Benzoapyrene in the follicular fluid of women with the unfulfilled desire to have children undergoing an intracytoplasmic sperm injection ICSI treatment The analysis will be performed using a sensitive gas chromatography-mass spectroscopy GC in a control group non-smoker and a study group smoker For each group a correlation analysis between the amount of toxic andor carcinogenic substances and the clinical outcome eg clinical pregnancy rate fertilization rate will be performed In combination with a patient questionnaire it will be possible to analyze the risk of smoking the bio-accumulation of toxic substances in the follicular fluid and the chance to have children
Combustion of tobacco products results in more than 4000 toxic andor carcinogenic substances Examples of such substances are the carcinogenic substance Benzoapyrene or nicotine and its main degradation product cotinine Although the adverse effects of these substances were analyzed in many biological systems eg cell culture mouse model systems less is known about the bio-accumulation in human tissue especially in ovarian tissue or the follicular fluid FF
The aim of this study is therefore to analyze the bio-accumulation of nicotine cotinine and Benzoapyrene in the follicular fluid of women with the unfulfilled desire to have children undergoing an intracytoplasmic sperm injection ICSI treatment The analysis will be performed using a sensitive gas chromatography-mass spectroscopy GC in a control group non-smoker and a study group smoker For each group a correlation analysis between the amount of toxic andor carcinogenic substances and the clinical outcome eg clinical pregnancy rate fertilization rate will be performed In combination with a patient questionnaire it will be possible to analyze the risk of smoking the bio-accumulation of toxic substances in the follicular fluid and the chance to have children
Detailed Description:
The desire to have children can be influenced by a number of factors Besides hormonal factors age and body weight or genetic disorders smoking may play an important role It was shown that cigarette smoking correlates with a significantly decreased implantation and life birth rate and a significantly higher risk for miscarriage or preterm birth Moreover limitations of the oocyte quality a decreased thickness of the Zona Pellucida or spindle disorders were reported Overall smokers are much less likely to succeed in pregnancy as published by the American Society for Reproductive Medicine ASRM in 2012 Although general tobacco consumption in Germany is declining about 30 of women of childbearing age between 18 and 45 years smoke German Federal Office of Statistics 2013
Combustion of tobacco products and additives like glycerin menthol or sorbic acid results in the formation of more than 4000 toxic andor carcinogenic substances Two of these substances are nicotine and its main degradation product cotinine another example is the carcinogenic substance Benzoapyrene The nicotine clearance in the human body is relatively fast - the half-life of nicotine is less than 2 hours in the human body However cotinine with a half-life of more than 16 hours is an appropriate biomarker to study the bio-accumulation of nicotinecotinine The effect of nicotine cotinine or Benzoapyrene on the reproductive system has already been investigated in various animal model systems and some clinical trials For example nicotine limits progesterone and estrogen biosynthesis reduces peripheral blood flow and reduces contractility of the fallopian tubes and uterus Benzoapyrene impairs cell proliferation as well as estrogen biosynthesis It has also been implicated in DNA damaging mechanisms
Nevertheless little is known about the bio-accumulation of these toxic substances in human tissue especially in the reproductive system eg ovarian tissue or the follicular fluid Some published studies were additionally limited because of their limited sample size n50 or non-sensitive analyzing tools eg enzyme-linked immunosorbent assay ELISA analysis The aim of this study is therefore to analyze the bio-accumulation of nicotine cotinine and Benzoapyrene in the follicular fluid of women with the unfulfilled desire to have children undergoing an intracytoplasmic sperm injection treatment using an ultra-sensitive gas chromatography-mass spectroscopy in a control group non-smoker and a study group smoker For each group a sample size of n150 will be included This makes it possible to perform a statistical analysis regarding the presence of smoking pollutants in the follicular fluid and the associated clinical parameters eg clinical pregnancy outcome oocyte count fertilization rate between the study and control group In combination with a patient questionnaire it will be possible to identify the risk of smoking the bio-accumulation of toxic substances in the follicular fluid and the desire to have children
Combustion of tobacco products and additives like glycerin menthol or sorbic acid results in the formation of more than 4000 toxic andor carcinogenic substances Two of these substances are nicotine and its main degradation product cotinine another example is the carcinogenic substance Benzoapyrene The nicotine clearance in the human body is relatively fast - the half-life of nicotine is less than 2 hours in the human body However cotinine with a half-life of more than 16 hours is an appropriate biomarker to study the bio-accumulation of nicotinecotinine The effect of nicotine cotinine or Benzoapyrene on the reproductive system has already been investigated in various animal model systems and some clinical trials For example nicotine limits progesterone and estrogen biosynthesis reduces peripheral blood flow and reduces contractility of the fallopian tubes and uterus Benzoapyrene impairs cell proliferation as well as estrogen biosynthesis It has also been implicated in DNA damaging mechanisms
Nevertheless little is known about the bio-accumulation of these toxic substances in human tissue especially in the reproductive system eg ovarian tissue or the follicular fluid Some published studies were additionally limited because of their limited sample size n50 or non-sensitive analyzing tools eg enzyme-linked immunosorbent assay ELISA analysis The aim of this study is therefore to analyze the bio-accumulation of nicotine cotinine and Benzoapyrene in the follicular fluid of women with the unfulfilled desire to have children undergoing an intracytoplasmic sperm injection treatment using an ultra-sensitive gas chromatography-mass spectroscopy in a control group non-smoker and a study group smoker For each group a sample size of n150 will be included This makes it possible to perform a statistical analysis regarding the presence of smoking pollutants in the follicular fluid and the associated clinical parameters eg clinical pregnancy outcome oocyte count fertilization rate between the study and control group In combination with a patient questionnaire it will be possible to identify the risk of smoking the bio-accumulation of toxic substances in the follicular fluid and the desire to have children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None