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Study on Exercise, Mediterranean Diet, and Aspirin for Women with Infertility Undergoing In Vitro Fertilization

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of different treatments on women's infertility, particularly in the context of in vitro fertilization (IVF). The study compares the impact of regular exercise and a Mediterranean diet with the use of aspirin or no intervention at all. The medication being used in this study is called TROMALYT, which contains acetylsalicylic acid, commonly known as aspirin. This medication is provided in the form of prolonged-release capsules, which means it releases the active ingredient slowly over time.

The purpose of the study is to evaluate how these different approaches affect the chances of having a live birth after IVF. Participants in the study will be randomly assigned to one of the treatment groups: exercise and Mediterranean diet, aspirin, or no intervention. The study will monitor the participants over a period to see which approach leads to a higher rate of live births.

Throughout the study, participants will follow their assigned treatment plan, and their progress will be observed to determine the effectiveness of each approach. The ultimate goal is to find out which method is most beneficial for improving live birth rates in women undergoing IVF. This information could help guide future treatment options for women facing infertility challenges.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must have primary infertility, be over 18 years old, and be candidates for single embryo transfer on day 5. Written consent is required.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of the study groups: exercise and Mediterranean diet, aspirin, or no intervention.

  3. Step 3

    Intervention phase

    If assigned to the aspirin group, take TROMALYT 150 mg prolonged-release capsules orally. The dosage and frequency are determined by the study protocol.

    Participants in the exercise and Mediterranean diet group follow a specific regimen designed to improve health outcomes before in vitro fertilization.

  4. Step 4

    In vitro fertilization (IVF)

    Undergo IVF treatment as planned. The goal is to achieve a successful embryo transfer on day 5.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring occurs to assess health and progress. The primary focus is on the cumulative live-birth rate, which measures the number of live births per 100 embryo transfers.

  6. Step 6

    Completion of study

    The study is estimated to conclude by September 30, 2027. Final assessments are conducted to evaluate the outcomes of the interventions.

Who can join the trial?

5 criteria

  • Participants must be women experiencing infertility, which means they have difficulty getting pregnant.
  • Participants should be seeking treatment through in vitro fertilization (IVF), a process where an egg is fertilized by sperm outside the body.
  • Participants must be over 18 years old.
  • Participants should be candidates for a single embryo transfer on day 5, which means transferring one fertilized egg into the uterus five days after fertilization.
  • Participants must provide written consent to join the study, which means they agree to participate after understanding the study details.

Who cannot join the trial?

4 criteria

  • Men cannot participate in the study. Only women are eligible.
  • Women who are not experiencing infertility are not eligible.
  • Participants must be within a specific age range, which is not specified here.
  • Individuals who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to protect their own interests, such as children or people with certain disabilities.
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Investigated drugs

  • Aspirin

    is a medication commonly used to reduce pain, fever, or inflammation. In this trial, it is being evaluated for its potential impact on the live-birth rate and cardiovascular health in individuals undergoing in vitro fertilization (IVF). The study aims to see if taking aspirin before IVF can improve outcomes compared to other interventions.

  • Exercise

    is a physical activity that is part of the trial to assess its effects on the live-birth rate and cardiovascular health in IVF patients. Participants will engage in a structured exercise program to determine if regular physical activity can enhance IVF success rates and improve overall health.

  • Mediterranean Diet

    is a dietary pattern included in the trial, characterized by high consumption of fruits, vegetables, whole grains, nuts, and olive oil, with moderate intake of fish and poultry. The trial investigates whether following this diet before IVF can positively influence the live-birth rate and cardiovascular health compared to other interventions.

What is already known about the treatment

Aspirin – Aspirin is typically administered orally in tablet form. It is a well-established medication in medical literature, primarily known for its use in pain relief, reducing inflammation, and preventing blood clots. In the context of this clinical trial, it is being evaluated for its potential impact on live birth rates in women undergoing in vitro fertilization. Aspirin works by inhibiting the enzyme cyclooxygenase, which reduces the production of substances that promote inflammation and blood clotting. It is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Investigated diseases

Female Infertility – Female infertility refers to a woman's inability to conceive after a year of regular, unprotected intercourse. It can result from various factors, including hormonal imbalances, structural issues with reproductive organs, or age-related factors. The condition may involve irregular or absent menstrual cycles, which can indicate problems with ovulation. Other potential causes include blocked fallopian tubes, uterine abnormalities, or endometriosis. The progression of infertility can vary, with some women experiencing temporary infertility due to lifestyle factors, while others may face more persistent challenges. Understanding the underlying cause is crucial for determining the appropriate approach to managing the condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515590-10-00Protocol codeIIBSP-EDA-2020-18Estimated enrolment150 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

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