NL-OMON51568招募中不适用
Changes in gut- and vaginal microbiome composition in association with PCOS clinical phenotypes - GuVa PCOS study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Age 18-45years (premenopausal)
- •- Caucasian
- •- Willing to provide vaginal swab and stool sample
- •- Willing to provide informed consent
- •- Sufficient command of the Dutch language
- •- Diagnosed with PCOS at Erasmus MC using the Rotterdam criteria by a presence
- •of at least two of the following criteria
- •o Clinical or biochemical hyperandrogenism (modified Ferriman-Gallway score >5;
- •testosterone level >2nmol/L, Free Androgen Index > 2.9)
- •o Oligomenorrorrhea or amenorrhea
- •o Polycystic ovaries.
- •Control group:
- •o Age 18-45years
- •o Caucasian
- •o Willing to provide vaginal and stool sample
- •o Willing to provide informed consent
- •o Regular menstrual cycle (25-35days)
- •o Sufficient command of the Dutch language
- •o No history of diagnosed PCOS and do not meet any of the Rotterdam criteria.
排除标准
- •- BMI <18
- •- Diabetes Mellitus or use of insulin sensitizer
- •- Chronic and acute infection diseases
- •- Endometriosis (American Fertility Score (AFS) III/IV)
- •- Elevated prolactin levels, thyroid disease, Cushing disease or
- •gastro-intestinal disease
- •- The use of hormonal contraceptives, other steroid hormones in last 3 months
- •- Use of antibiotics, probiotics or laxatives in the last 3 months
- •The exclusion criteria also applies to the control group
研究者
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