Fertility: Infection and Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- clincal pregnancy
研究概览
简要总结
The investigators explore whether inflammatory factors and infections in collected samples are altered in fertility issues and if they can predict pregnancy outcomes. The investigators focus on pro- and anti-inflammatory markers, such as cytokines, metabolic parameters (e.g., blood lipids, hormones, bile acids), and viral infections (e.g., HPV, herpesviruses). A standard blood panel is also performed.
Fertility issues are rising due to aging, infections, environmental toxins, and lifestyle factors (e.g., BMI, diabetes). Fertilization and implantation involve complex interactions between the egg, sperm, embryo, and endometrium, which can be disrupted by inflammatory processes from infections, metabolic imbalances, or environmental toxins. IVF allows access to unique samples that help identify these processes and their impact on fertility.
- Sample Collection & Analysis
- Diagnostic Cycle: Blood samples (early/late follicular phase), endometrial sample (7 days post-ovulation), and body composition analysis (BOD POD).
- Oocyte Retrieval: Blood, follicular fluid, vaginal swab, and another body composition analysis (BOD POD). The male partner provides blood and an ejaculate sample.
- After IVF: The culture medium where the fertilized egg grows is collected. Samples are analyzed for hormones, cytokines, metabolites, nucleic acids, proteins, and immune cells. Some granulosa cells are isolated and cultured.
- Clinical & Fertility Parameters
The main outcome is a clinical pregnancy, but additional factors are examined:
- Patient: IVF reason, AMH levels, pre-existing conditions, medications, smoking, pregnancy duration.
- IVF parameters: Follicle counts, retrieved oocytes, fertilization method (IVF/ICSI), embryo quality, implantation rate, miscarriage rate, and live birth rate.
- Newborn: Birth weight, length, sex.
- Control Groups & Data Management Control groups consist of couples where infertility is attributed to only one partner. All samples are pseudonymized before analysis to ensure data privacy.
详细描述
The investigators aim to investigate whether inflammatory and inflammation-inducing factors detectable in the collected samples, as well as infections present in these samples, are altered in cases of fertility issues and whether these factors could be predictive of pregnancy progression and child outcomes. Specifically, factors that mediate inflammation-acting either pro-inflammatory or anti-inflammatory-will be examined for their association with pregnancy establishment. This includes, for example, signaling molecules such as cytokines, metabolic and endocrinological parameters that may contribute to a pro-inflammatory milieu (e.g., hyperglycemia, blood lipids, hormones), viral infections that may influence fertility (e.g., human papillomavirus (HPV), herpesviruses). Additionally, a standard blood panel will be performed.
Fertility issues are increasing in both women and men. The causes are not only due to the higher age of couples wishing to conceive but also to infections, environmental factors (e.g., environmental toxins), and lifestyle-associated factors (e.g., BMI, increased body fat percentage, and diabetes). The fertilization of the egg and the implantation of the embryo into the endometrium is a highly complex process influenced by many factors. The egg, sperm, embryo, and endometrium all play a crucial role. Essential are, on the one hand, factors secreted by these components, which are present in maternal blood, follicular fluid, or ejaculate, and on the other hand, factors produced by the mother that influence the egg, fertilization, embryo, and endometrium.
Inflammatory processes, such as those occurring due to viral or bacterial infections, metabolic dysregulations (diabetes or obesity), or exposure to environmental substances (environmental toxins), may alter the normal milieu and thereby affect fertilization and implantation. In the context of assisted reproductive technologies (in vitro fertilization, IVF), the investigators have the opportunity to analyze samples that are not accessible during natural conception. These samples allow us to identify the presence of inflammatory processes and investigate their impact on pregnancy establishment.
- Sample Collection:
In the diagnostic cycle-a cycle preceding further fertility treatment, during which possible causes of infertility are assessed-blood samples in both the early and late follicular phase (cycle days 2-5 and 19-21) will be collected and an endometrial sample (7 days after ovulation). Additionally body composition (including body fat percentage) is measured in the BOD POD and via ultrasound.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, and optionally their partners, aged 18 or older with written consent to participate in the study.
排除标准
- •Minors and patients unable to provide consent. Conditions or circumstances that, in the opinion of the investigator or treating physician, could interfere with the study.
结局指标
主要结局
clincal pregnancy
时间窗: 7 weeks after oocyte transfer
establishment of a clinical pregnancy
次要结局
未报告次要终点
