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

NCT03414567 | Completed

• 1 other identifier: Nicotine Folicular Fluid 2018
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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 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

Keywords

Follicular fluid; nicotine; cotinine; Benzo(a)pyrene

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Presence of amniotic cavity and heartbeat after embryo transfer

  28 days after ICSI treatment

Study Arms (2)

Control Group

Non-smoker

Study Group

Smoker

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

female patients seeking ICSI treatment because of male subfertility

You may qualify if:

• \- healthy females without sterility factors

You may not qualify if:

• Endometriosis
• Polycystic ovary syndrome (PCO)
• Neoplasia (ovary, Uterus, breast)
• Anti-Müllerian hormone (AMH) \<1 ng/ml

Sponsors & Collaborators

• Infertility Treatment Center Dortmund: lead
• TU Dortmund University: collaborator
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Infertility treatment center Dortmund

Dortmund, North Rhine-Westphalia, 44135, Germany

Location

Related Publications (1)

• Trapphoff T, Ontrup C, Krug S, Dieterle S. Consumption of hookahs, e-cigarettes, and classic cigarettes and the impact on medically assisted reproduction treatment. Sci Rep. 2024 Apr 26;14(1):9597. doi: 10.1038/s41598-024-60251-y.

  PMID: 38671174 DERIVED

Related Links

• Trapphoff et al., 2024 (Consumption of hookahs, e-cigarettes, and classic cigarettes and the impact on medically assisted reproduction treatment)

Biospecimen

Retention: SAMPLES WITHOUT DNA

Follicular fluid

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Stefan Dieterle, MD

  Infertility Treatment Center Dortmund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: March 1, 2018
• Primary Completion: December 30, 2023
• Study Completion: May 28, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)