Impact of Exercise and Mediterranean diet vs Aspirin on live-birth rate and cardiovascular programming in In Vitro Fertilization (MEDITATE-IVF)

Impact of Exercise and Mediterranean diet vs Aspirin on live-birth rate and cardiovascular programming in In Vitro Fertilization (MEDITATE-IVF): a Randomized Study. - MEDITATE-IVF

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001069-35-ES

Enrollment

750

Registered

2021-07-08

Start date

2021-07-06

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cumulative live-birth rate.

Interventions

Trade Name: Tromalyt Product Name: Tromalyt Pharmaceutical Form: Capsule INN or Proposed INN: ACETYLSALICYLIC ACID CAS Number: 50-78-2 Concentration unit: mg milligram(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with primary infertility justifying IVF treatment, who wish to become pregnant, aged between 18 and ?38 years, candidates for single embryo transfer in day 5, who give written consent when invited to participate in the study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 750 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Low ovarian reserve (defined as anti-Mullerian hormone ?1 ng/mL), 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, previous unsuccessful IVF cycles, probability of loss to follow-up, probability of delivery occurring in another hospital or centre.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the impact of exercise and Mediterranean diet vs LDA vs no intervention 6 months previous to ICF, on cumulative live-birth rate.;Secondary Objective: -To evaluate basal CV risk parameters in women awaiting IVF procedures. -To evaluate CV risk parameters in women awaiting IVF procedures 6 months after pre-conception interventions. -To evaluate placental function biomarkers in the 1st and 3rd trimester of all study groups. -To evaluate maternal cardiac function parameters upon inclusion, previous to IVF, at 1st and 3rd trimester of pregnancy and compare between study groups. -To evaluate foetal cardiac function parameters at 3rd trimester of pregnancy and compare between study groups. -To describe the incidence of adverse perinatal outcomes, both maternal and foetal, in the study groups.;Primary end point(s): Cumulative live-birth rate: defined as the number of deliveries that result in a live born neonate, expressed per 100 embryo transfers.;Timepoint(s) of evaluation of this end point: When delivery occurs.	—

Measure

Time frame

Main Objective: To evaluate the impact of exercise and Mediterranean diet vs LDA vs no intervention 6 months previous to ICF, on cumulative live-birth rate.;Secondary Objective: -To evaluate basal CV risk parameters in women awaiting IVF procedures. -To evaluate CV risk parameters in women awaiting IVF procedures 6 months after pre-conception interventions. -To evaluate placental function biomarkers in the 1st and 3rd trimester of all study groups. -To evaluate maternal cardiac function parameters upon inclusion, previous to IVF, at 1st and 3rd trimester of pregnancy and compare between study groups. -To evaluate foetal cardiac function parameters at 3rd trimester of pregnancy and compare between study groups. -To describe the incidence of adverse perinatal outcomes, both maternal and foetal, in the study groups.;Primary end point(s): Cumulative live-birth rate: defined as the number of deliveries that result in a live born neonate, expressed per 100 embryo transfers.;Timepoint(s) of evaluation of this end point: When delivery occurs.

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Secondary

Measure	Time frame
Secondary end point(s): Adverse perinatal outcome: defined as the presence of either of the following: miscarriage, stillbirth, low birth weight, preterm birth, preeclampsia, congenital malformations and/or admission to neonatal ICU. • High risk of PE (preeclampsia) according to first trimester screening: a logistic regression-based predictive model for early and late onset PE will be used, according to a validated algorithm including maternal characteristics, levels of pregnancy-associated plasma protein-A (PAPP-A) and free ß-Human chorionic gonadotropin (ß-hCG) at 8-12 weeks, and blood pressure and uterine artery Doppler at 11.0-13.6 weeks. Details of this screening method have previously been described and are available for clinical use. • Preeclampsia: categorized according to the guidelines of the Royal College of Obstetricians and Gynaecologists. Briefly, hypertension will be defined as the repeated measurement of systolic blood pressure of =140 mm Hg (Korotkoff I) and diastolic blood pressure of =90 mm Hg (Korotkoff V). Proteinuria will be defined as the excretion of 300 mg protein or greater per day in the 24-hour urine collection or a repeated dipstick of =1+. Pregnancy-induced hypertension (PIH) will be defined as the new onset of hypertension after 20 weeks of gestation, and preeclampsia (PE) will be defined when additional proteinuria was diagnosed according to International Society for the Study of Hypertension in Pregnancy. • Incidence of adverse events and serious adverse events summarized by treatment groups.;Timepoint(s) of evaluation of this end point: • It will be registered when the adverse outcome happens, if it may. • First pregnancy trimester. • It will be registered when the adverse outcome happens, if it may. • It will be registered when the adverse outcome happens, if it may.	—

Measure

Time frame

Secondary end point(s): Adverse perinatal outcome: defined as the presence of either of the following: miscarriage, stillbirth, low birth weight, preterm birth, preeclampsia, congenital malformations and/or admission to neonatal ICU. • High risk of PE (preeclampsia) according to first trimester screening: a logistic regression-based predictive model for early and late onset PE will be used, according to a validated algorithm including maternal characteristics, levels of pregnancy-associated plasma protein-A (PAPP-A) and free ß-Human chorionic gonadotropin (ß-hCG) at 8-12 weeks, and blood pressure and uterine artery Doppler at 11.0-13.6 weeks. Details of this screening method have previously been described and are available for clinical use. • Preeclampsia: categorized according to the guidelines of the Royal College of Obstetricians and Gynaecologists. Briefly, hypertension will be defined as the repeated measurement of systolic blood pressure of =140 mm Hg (Korotkoff I) and diastolic blood pressure of =90 mm Hg (Korotkoff V). Proteinuria will be defined as the excretion of 300 mg protein or greater per day in the 24-hour urine collection or a repeated dipstick of =1+. Pregnancy-induced hypertension (PIH) will be defined as the new onset of hypertension after 20 weeks of gestation, and preeclampsia (PE) will be defined when additional proteinuria was diagnosed according to International Society for the Study of Hypertension in Pregnancy. • Incidence of adverse events and serious adverse events summarized by treatment groups.;Timepoint(s) of evaluation of this end point: • It will be registered when the adverse outcome happens, if it may. • First pregnancy trimester. • It will be registered when the adverse outcome happens, if it may. • It will be registered when the adverse outcome happens, if it may.

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Countries

Spain

Contacts

Public ContactUICEC Sant Pau

Institut de Recerca H. Santa Creu i Sant Pau.

uicec@santpau.cat+34935537636

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026