Overview
Sponsor-declared trial summary
Women infertility
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.
Key facts
- Sponsor
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 16 Sep 2021 → ongoing
- Decision date (initial)
- 2024-07-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515590-10-00
- EudraCT number
- 2020-001069-35
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
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.
Conditions and MedDRA coding
Women infertility
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 2
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Cumulative live-birth rate: defined as the number of deliveries that result in a live born neonate, expressed per 100 embryo transfers.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
TROMALYT 150 mg cápsulas duras de liberación prolongada
PRD4426046 · Product
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC — PLATELET AGGREGATION INHIBITORS EXCL. HEPARIN
- Marketing authorisation
- 59210
- MA holder
- MEDA PHARMA S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Sponsor organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Address
- Calle Sant Quinti 77-79
- City
- Barcelona
- Postcode
- 08041
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- UICEC Sant Pau
Public contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- UICEC Sant Pau
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 150 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2021-09-16 | 2021-11-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | IIBSP-EDA-2020-18_Protocolo_V4 para publicar | 4 |
| Recruitment arrangements (for publication) | K2_Recruitement material | 1 |
| Subject information and informed consent form (for publication) | IIBSP-EDA-2020-18_HIP CI_V3 para publicar | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_biological samples | 2 |
| Synopsis of the protocol (for publication) | Resumen v4 para publicar | 4 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-05 | Spain | Acceptable with conditions 2024-07-15
|
2024-07-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-04 | Spain | Acceptable 2024-11-06
|
2024-11-15 |