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

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What is this study about?

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.

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 randomization

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

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 in vitro fertilization (IVF)

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

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 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 Study?

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 Study?

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.

Where you can join this trial?

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Site Name	City	Country	Status
Hjvynrhs Dj Ld Slszv Cnbv I Snac Pqz	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.07.2021

Trial locations

Investigated drugs:

Acetylsalicylic Acid

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.

Investigated diseases:

Infertility female

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 ID:

2024-515590-10-00

Protocol code:

IIBSP-EDA-2020-18

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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