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Presence of Toxins from Smoking in the Follicular Fluid of Women Undergoing Intracytoplasmic Sperm Injection Treatment

NCT03414567 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2024-11-04

No results posted yet for this study

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 4.000 toxic and/or carcinogenic substances. Examples of such substances are the carcinogenic substance Benzo(a)pyrene or nicotine and its main degradation product cotinine. Although the adverse effects of these substances were analyzed in many biological systems (e.g. 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 Benzo(a)pyrene 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 and/or carcinogenic substances and the clinical outcome (e.g. 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.

Conditions

  • Exposure to Toxins from Smoking
  • Female Infertility

Sponsors & Collaborators

  • TU Dortmund University

    collaborator UNKNOWN

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • Infertility Treatment Center Dortmund

    lead OTHER

Principal Investigators

  • Stefan Dieterle, MD · Infertility Treatment Center Dortmund

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2023-12-30
Completion
2024-05-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03414567 on ClinicalTrials.gov