Female Infertility Clinical Trial
Official title:
Presence of Toxins From Smoking in the Follicular Fluid of Women With the Desire to Have Children Undergoing Intracytoplasmic Sperm Injection Treatment
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | April 30, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - healthy females without sterility factors Exclusion Criteria: - Endometriosis - Polycystic ovary syndrome (PCO) - Neoplasia (ovary, Uterus, breast) - Anti-Müllerian hormone (AMH) <1 ng/ml |
Country | Name | City | State |
---|---|---|---|
Germany | Infertility treatment center Dortmund | Dortmund | NRW |
Lead Sponsor | Collaborator |
---|---|
Infertility Treatment Center Dortmund | Ferring Pharmaceuticals, TU Dortmund University |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical pregnancy rate | Presence of amniotic cavity and heartbeat after embryo transfer | 28 days after ICSI treatment |
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