NCT04670393已完成不适用
Impact of the Administration of an Antioxidant Food Supplement Associated With Oral Probiotics on the Ovarian Oxidative Stress Profile and the Intestinal Microbiota Function in the in Vitro Fertilization Cycle of Patients With Polycystic Ovarian Syndrome
Fertypharm2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年12月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of MII oocytes
研究概览
简要总结
The aim of the study is to study the effect of an antioxidant food supplement associated with probiotics on the oocyte quality response, oxidative stress and microbiota function in an in vitro fertilization cycle in patients with polycystic ovarian syndrome
详细描述
After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will be randomized in a double-blind manner in a ratio 1:1 to receive the antioxidant supplementation associated with probiotics (Myo-Inositol, D-Chiro-Inositol, folic acid, selenium, vitamin D, Melatonin, Lactobacillus rhamnosus, Lactobacillus cripatus and Lactobacillus plantarum) or placebo (folic acid) once daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age:18-38 years old
- •Diagnosis of PCOS according to compliance with the Rotterdam criteria
- •BMI >= 25
排除标准
- •Hormonal contraceptive, insulin sensitizers such as metformin, inositols, antioxidants, vitamin supplements except folic acid, GnRH analogs, steroidal drugs or others with anti-inflammatory properties, antibiotics, probiotics, laxatives use in the 3 months prior to recruitment
- •Tobacco consumption in last 12 months
- •Endometriosis, hydrosalpinx not surgically treated, acute or chronic inflammatory diseases, systemic immune diseases, other endocrine diseases or dysfunctions except for PCOS and subclinical hypothyroidism treated with low doses of levothyroxine (eg congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, Diabetes Millitus, hyperprolactinemia, hyperglycemia), active neoplastic disease or without evidence of complete remission for at least 5 years,
- •Active participation in an active weight reduction program or hypocaloric diet during the study period. No change in habits will be taught during the study period
- •Hypersensitivity to any of the components in the Fertybiotic Mujer Plus® formulation
结局指标
主要结局
Number of MII oocytes
时间窗: 3 months in follicular puncture visit
次要结局
- LH(Baseline and about 2,5 months when the cycle treatment starts)
- Insulin(Baseline and about 2,5 months when the cycle treatment starts)
- SCFA(Baseline and about 2,5 months when the cycle treatment starts)
- Oocytes(3 months in follicular puncture visit)
- FSH(Baseline and about 2,5 months when the cycle treatment starts)
- Sirtuin(3 months in follicular puncture visit)
- Pregnancy rate(Through study completion, an average of 1 year)
- Glucose(Baseline and about 2,5 months when the cycle treatment starts)
- Androstendione(Baseline and about 2,5 months when the cycle treatment starts)
- Testosterone(Baseline and about 2,5 months when the cycle treatment starts)
- Glutation(3 months in follicular puncture visit)
- Zonulin(Baseline and about 2,5 months when the cycle treatment starts)
- Follicles(3 months in follicular puncture visit)
- Stimulation days(3 months in follicular puncture visit)
- MDA(Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture))
- TAC(Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture))
- 8-OH-desoxiguanosin(3 months in follicular puncture visit)
- Gonadotropin UI(3 months in follicular puncture visit)
- Live birth rate(Through study completion, an average of 1 year)
研究者
研究点 (2)
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