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Association of the Mediterranean Diet With Fertility Outcomes (MedDietIVF)

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ClinicalTrials.gov Identifier: NCT03050944
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : February 14, 2017
Sponsor:
Collaborator:
Embryogenesis Assisted Conception Unit
Information provided by (Responsible Party):
Nikos Yiannakouris, Harokopio University

Brief Summary:
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.

Condition or disease Intervention/treatment
Infertility Other: Lifestyle behaviour and dietary habits assessment

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Association of the Mediterranean Diet With Fertility Outcomes: a Study Among Couples Undergoing in Vitro Fertilization Treatment
Actual Study Start Date : June 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Group/Cohort Intervention/treatment
Cases
Lifestyle behaviour and dietary habits assessment in couples achieving pregnancy after in vitro fertilization process.
Other: Lifestyle behaviour and dietary habits assessment
Lifestyle behaviour and dietary habits assessment

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




Primary Outcome Measures :
  1. Live Birth [ Time Frame: 9 months ]
    Birth of a neonate on or after 24 weeks gestation


Secondary Outcome Measures :
  1. Hormonal profile [ Time Frame: 3 months ]
    Baseline serum E2, anti-mullerian hormone, inhibin b, luteinizing hormone, follicle stimulating hormone concentrations.

  2. Oocyte number. [ Time Frame: 3 months ]
    Total Number of oocytes produced.

  3. Oocyte quality. [ Time Frame: 3 months ]
    The morphological feature of each oocyte wil be evaluated with the aid of inverted microscope. The criteria employed for the morphological evaluation of oocytes are: a. normal oocytes showed clear cytoplasm with homogenous fine granularity; b. granular oocytes, dark with granularity either homogenous in whole cytoplasm or concentrated in the central portion of oocyte; c. cytoplasmic inclusions comprised vacuoles presumed to be of endocytotic origin; d. anomalies of zona pellucida e. fragmented polar body of different sizes; f. non-spherical shape of oocyte; and g. wide perivitelline space.

  4. Embryo number. [ Time Frame: 3 months ]
    Total Number of embryos produced.

  5. Embryo quality. [ Time Frame: 3 months ]
    Embryo morphology will be assessed as follows: 44 h ± 1 h after intracytoplasmatic sperm injection, for day two evaluation and 68h ± 1 h after intracytoplasmatic sperm injection, for day 3 evaluation. Embryo morphology will be carried out using an inverted microscope

  6. Semen volume. [ Time Frame: 1 month. ]
    Ejaculate volumes will be estimated by specimen weight, assuming a semen density of 1.0 g/ml.

  7. Semen concentration. [ Time Frame: 1 month. ]
    Sperm concentration will be evaluated by hemocytometer Motility will be assessed in accordance with the World Health Organization 2010 criteria

  8. Semen morphology. [ Time Frame: 1 month. ]
    Regarding semen morphology, the World Health Organization criteria as described in 2010 state that a sample is normal if 4% (or 5th centile) or more of the observed sperm have normal morphology.

  9. Semen Motility. [ Time Frame: 1 month. ]
    Motility will be assessed in accordance with the World Health Organization 2010 criteria and classified as progressive motile (A + B), total motile (A + B + C), or immotile (D).

  10. Fertilization rate [ Time Frame: 3 months ]
    Fertilization rate will be determined on day 1 after the IVF/intracytoplasmatic sperm injection procedure, and is going to calculated as the number of fertilized oocytes divided by the total number of oocytes retrieved

  11. Serum Adiponectin [ Time Frame: 6 months ]
    Serum adiponectin levels will be measured by ELISA method on day 1 of the ovarian stimulation protocol, on day 3, on day 5, on day 7, on day 9 and the day of oocyte retrieval.

  12. Follicular Fluid Adiponectin [ Time Frame: 6 months ]
    Follicular fluid adiponectin levels from the dominant oocyte will be measured by ELISA method.

  13. Follicular Fluid Follistatin, [ Time Frame: 6 months ]
    Follicular fluid follistatin levels from the dominant oocyte will be measured by ELISA method.

  14. Clinical Pregnancy [ Time Frame: 6 months ]
    Elevation in b-human chorionic gonadotropin with the confirmation of an intrauterine pregnancy by ultrasound, first performed at 6 weeks of gestation


Biospecimen Retention:   Samples Without DNA
Blood, follicular fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subfertile couples undergoing IVF treatment at a Fertility Clinic in Athens
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050944


Locations
Greece
Harokopio University
Athens, Attiki, Greece, 10676
Sponsors and Collaborators
Harokopio University
Embryogenesis Assisted Conception Unit
Investigators
Principal Investigator: Nikolaos Yiannakouris, PhD Associate Professor of Physiology

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nikos Yiannakouris, Assοciate Professor of Physiology, Harokopio University, Harokopio University
ClinicalTrials.gov Identifier: NCT03050944     History of Changes
Other Study ID Numbers: 57
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nikos Yiannakouris, Harokopio University:
Fertility
Infertility
Dietary Patterns
Mediterranean diet
Adiponectin
Follistatin
Assisted Reproduction
In Vitro Fertilization
Semen quality
Diet
IVF

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female