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Association of the Mediterranean Diet With Fertility Outcomes (MedDietIVF)

13. února 2017 aktualizováno: Nikos Yiannakouris, Harokopio University

Association of the Mediterranean Diet With Fertility Outcomes: a Study Among Couples Undergoing in Vitro Fertilization Treatment

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

250

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Attiki
      • Athens, Attiki, Řecko, 10676
        • Harokopio University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 60 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Subfertile couples undergoing IVF treatment at a Fertility Clinic in Athens

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Cases
Lifestyle behaviour and dietary habits assessment in couples achieving pregnancy after in vitro fertilization process.
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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Live Birth
Časové okno: 9 months
Birth of a neonate on or after 24 weeks gestation
9 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Hormonal profile
Časové okno: 3 months
Baseline serum E2, anti-mullerian hormone, inhibin b, luteinizing hormone, follicle stimulating hormone concentrations.
3 months
Oocyte number.
Časové okno: 3 months
Total Number of oocytes produced.
3 months
Oocyte quality.
Časové okno: 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.
3 months
Embryo number.
Časové okno: 3 months
Total Number of embryos produced.
3 months
Embryo quality.
Časové okno: 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
3 months
Semen volume.
Časové okno: 1 month.
Ejaculate volumes will be estimated by specimen weight, assuming a semen density of 1.0 g/ml.
1 month.
Semen concentration.
Časové okno: 1 month.
Sperm concentration will be evaluated by hemocytometer Motility will be assessed in accordance with the World Health Organization 2010 criteria
1 month.
Semen morphology.
Časové okno: 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.
1 month.
Semen Motility.
Časové okno: 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).
1 month.
Fertilization rate
Časové okno: 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
3 months
Serum Adiponectin
Časové okno: 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.
6 months
Follicular Fluid Adiponectin
Časové okno: 6 months
Follicular fluid adiponectin levels from the dominant oocyte will be measured by ELISA method.
6 months
Follicular Fluid Follistatin,
Časové okno: 6 months
Follicular fluid follistatin levels from the dominant oocyte will be measured by ELISA method.
6 months
Clinical Pregnancy
Časové okno: 6 months
Elevation in b-human chorionic gonadotropin with the confirmation of an intrauterine pregnancy by ultrasound, first performed at 6 weeks of gestation
6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Nikolaos Yiannakouris, PhD, Associate Professor of Physiology

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. června 2013

Primární dokončení (Aktuální)

1. září 2016

Dokončení studie (Aktuální)

1. prosince 2016

Termíny zápisu do studia

První předloženo

3. února 2017

První předloženo, které splnilo kritéria kontroly kvality

8. února 2017

První zveřejněno (Aktuální)

13. února 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. února 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. února 2017

Naposledy ověřeno

1. února 2017

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

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Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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