Association of the Mediterranean Diet With Fertility Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Infertility affects one of every six couples and one out of ten couples may seek fertility treatment such as ovulation induction and assisted reproductive technologies. With respect to diet, several dietary factors, i.e. micro-, macro-nutrients and individual food groups, have been associated with the risk of subfertility; however, more information is needed on the role of dietary factors in reproductive functions. However, evidence concerning the association between dietary patterns, such as the Mediterranean diet (MD) pattern, and fertility is scarce. The aim of this study is to investigate the relationship between preconception dietary patterns, especially the MD pattern, and in vitro fertilization (IVF) outcomes, as well as adiponectin and follistatin concentrations in the plasma and follicular fluid of women undergoing IVF treatment. Blood and follicular fluid adiponectin and follistatin concentrations will be measured on each day of the ovarian stimulation protocol. Main IVF treatment outcomes are fertilization rate, oocyte and embryo quality, implantation, clinical pregnancy and live birth rates.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity in the Offspring

NCT03337802

Food Allergy

COMPLETED NA

Mediterranean Dietary Intervention on ROS Levels and TAC During Pregnancy

NCT07214402

Healthy Pregnant Women

COMPLETED NA

Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring

NCT05119868

Allergies Obesity Gestational Complications +5 more

RECRUITING NA

Mediterranean Diet on Pregnancy and Foetus Development

NCT05403632

Pregnancy Outcomes Fetal Development Infant Development

RECRUITING

Pregnancy in Greek Female Patients With Inflammatory Bowel Disease - Panhellenic Recording

NCT05562726

Inflammatory Bowel Diseases Pregnancy Related

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Infertility affects one of every six couples and one out of ten couples may seek fertility treatment such as ovulation induction and assisted reproductive technologies. There are multiple causes of infertility, including ovulatory disorders, endometriosis and sperm factors, or even psychological problems, among others. Modifiable lifestyle factors, such as diet, smoking and physical activity, may also affect fertility. With respect to diet, several dietary factors, i.e. micro-, macro-nutrients and individual food groups, have been associated with the risk of subfertility; however, more information is needed on the role of dietary factors in reproductive functions. A more comprehensive approach to investigate the associations between dietary factors and health outcomes is to assess the impact of the overall diet rather than separate foods or nutrients. However, evidence concerning the association between dietary patterns, such as the Mediterranean diet (MD) pattern, and fertility is scarce. The benefits of the MD on health have been well-publicized; it is associated with a significant reduction of overall mortality, cardiovascular disease and cancer. Adherence to the MD also seems to reduce the risk of weight gain and diabetes, conditions that raise insulin resistance and may thus lead to ovulatory infertility. Recently, adherence to MD was also associated with an increase in circulating adiponectin levels, a hormone produced by the adipose tissue that acts to reduce insulin resistance. Interestingly, adiponectin has been shown to exert actions in the female reproductive system, including the hypothalamic-pituitary ovarian axis and endometrium, and thus, it can be hypothesized that MD may exert a beneficial effect on reproductive functions through a raising effect on adiponectin levels. The aim of this study is to investigate the relationship between preconception dietary patterns, especially the MD pattern, and in vitro fertilization (IVF) outcomes, as well as adiponectin and follistatin concentrations in the plasma and follicular fluid of women undergoing IVF treatment.

Two-hundred subfertile couples undergoing IVF treatment at a Fertility Clinic in Athens (www.embryogenesis.gr/) will be invited to participate. Participants will fill out the following questionnaires: a general questionnaire to record the baseline characteristics of the subjects (age, educational level, annual income, medical history, body mass index, smoking, etc), a semi-quantitative 77-item food frequency questionnaire to assess habitual dietary intakes, and a 40-item state-trait anxiety inventory instrument to measure anxiety symptoms. Dietary patterns will be evaluated using principal component analysis and factor analysis. Adherence to the MD will be assessed with a MD-score that incorporates the inherent characteristics of this traditional diet, that is, high intake of plant foods and olive oil, low intake of meat and dairy products, and moderate intake of alcohol. Blood and follicular fluid adiponectin and follistatin concentrations will be measured on each day of the ovarian stimulation protocol. Main IVF treatment outcomes are fertilization rate, embryo quality, implantation, clinical pregnancy and live birth.

Associations between dietary patterns, adiponectin and follistatin concentrations and the IVF treatment outcomes will be tested using linear and logistic regression analyses, adjusting for potential confounders (e.g. age, smoking, anxiety symptoms, etc). The findings of the study could contribute in the development of guidelines to prevent infertility or to nutritional management associated to infertility treatments to improve reproductive performance. Furthermore, the elucidation of the role of adiponectin and follistatin in female reproductive functions and its association with dietary variables and the IVF outcomes could lead to the use of adiponectin or follistatin as therapeutic targets in novel treatment strategies of infertility disorders.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cases

Lifestyle behaviour and dietary habits assessment in couples achieving pregnancy after in vitro fertilization process.

Lifestyle behaviour and dietary habits assessment

Intervention Type OTHER

Lifestyle behaviour and dietary habits assessment

Controls

Lifestyle behaviour and dietary habits assessment in couples failed to achieve pregnancy after in vitro fertilization process.

Lifestyle behaviour and dietary habits assessment

Intervention Type OTHER

Lifestyle behaviour and dietary habits assessment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lifestyle behaviour and dietary habits assessment

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Presence of subfertility (male or female origin)

Exclusion Criteria

* Women's age \<41.
* Previous IVF attempt or pregnancy.
* Female obesity (BMI\>30 kgr/m2).
* Endometriosis
* Oocyte donation.
* Adherence to a hypocaloric diet for weight loss or changes in dietary habits during the last six months.
* Presence of female diabetes mellitus, cardiovascular disease, hypertension, neoplasm, hypothyroidism or psychiatric disorders.
* Previous ovarian surgery.
* Natural cycle IVF.
* Couples whose male partner shows an abnormality of the male genital tractus : Varicocele, undescended testis, testicular volume \< 12ml

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes