2024-515590-10-00RecruitingPhase 3
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 site in 1 country150 target enrollmentStarted: July 15, 2024Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Cumulative live-birth rate: defined as the number of deliveries that result in a live born neonate, expressed per 100 embryo transfers.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
UICEC Sant Pau
Scientific
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Study Sites (1)
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