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Association of the Mediterranean Diet With Fertility Outcomes (MedDietIVF)

13 de fevereiro de 2017 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

250

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Attiki
      • Athens, Attiki, Grécia, 10676
        • Harokopio University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 60 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Subfertile couples undergoing IVF treatment at a Fertility Clinic in Athens

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Live Birth
Prazo: 9 months
Birth of a neonate on or after 24 weeks gestation
9 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Hormonal profile
Prazo: 3 months
Baseline serum E2, anti-mullerian hormone, inhibin b, luteinizing hormone, follicle stimulating hormone concentrations.
3 months
Oocyte number.
Prazo: 3 months
Total Number of oocytes produced.
3 months
Oocyte quality.
Prazo: 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.
Prazo: 3 months
Total Number of embryos produced.
3 months
Embryo quality.
Prazo: 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.
Prazo: 1 month.
Ejaculate volumes will be estimated by specimen weight, assuming a semen density of 1.0 g/ml.
1 month.
Semen concentration.
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 6 months
Follicular fluid adiponectin levels from the dominant oocyte will be measured by ELISA method.
6 months
Follicular Fluid Follistatin,
Prazo: 6 months
Follicular fluid follistatin levels from the dominant oocyte will be measured by ELISA method.
6 months
Clinical Pregnancy
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Nikolaos Yiannakouris, PhD, Associate Professor of Physiology

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2013

Conclusão Primária (Real)

1 de setembro de 2016

Conclusão do estudo (Real)

1 de dezembro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

3 de fevereiro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de fevereiro de 2017

Primeira postagem (Real)

13 de fevereiro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de fevereiro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de fevereiro de 2017

Última verificação

1 de fevereiro de 2017

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 57

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .