2024-515590-10-00招募中3 期
Impact of Exercise and Mediterranean diet vs Aspirin on live-birth rate and cardiovascular programming in In Vitro Fertilization (MEDITATE-IVF): a Randomized Study.
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年7月15日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cumulative live-birth rate: defined as the number of deliveries that result in a live born neonate, expressed per 100 embryo transfers.
研究概览
简要总结
To evaluate the impact of exercise and the Mediterranean diet vs. aspirin, or no intervention, prior to in vitro fertilization, on the cumulative live birth rate.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with primary infertility justifying IVF treatment, who wish to become pregnant, > 18 years of age, candidates for single embryo transfer in day 5, who give written consent when invited to participate in the study protocol
排除标准
- •Pregnancy at the moment of inclusion, presence of comorbidities that contraindicate IVF, pregnancy or childbirth, known allergies to any of the interventions to be applied, probability of loss to follow-up, probability of delivery in another hospital or center.
- •Patients with conditions where LDA administration is contraindicated will also be excluded; some of these conditions or comorbidities would also contraindicate IVF. · Allergy to acetylsalicylic acid or any of the other components. · Gastric ulcer, duodenal or recurrent gastric symptoms. · Allergic asthmatic reactions when taking anti-inflammatories, acetylsalicylic acid, other analgesics, as well as the dye tartrazine. · Hemophilia or other blood clotting problems that predispose to bleeding. · Severe kidney and / or liver failure. · Asthmatic crises, with or without nasal polyps, after ingestion of acetylsalicylic acid. · Diagnosis of glucose-6-phosphate dehydrogenase deficiency. · Treatment with oral anticoagulants. · Treatment with anti-inflammatories or other types of drugs that can interact with LDA. · Hypertension treated with diuretics and angiotensin converting enzyme (ACE) inhibitors.
结局指标
主要结局
Cumulative live-birth rate: defined as the number of deliveries that result in a live born neonate, expressed per 100 embryo transfers.
Cumulative live-birth rate: defined as the number of deliveries that result in a live born neonate, expressed per 100 embryo transfers.
次要结局
未报告次要终点
研究者
UICEC Sant Pau
Scientific
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
研究点 (1)
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