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Association of the Mediterranean Diet With Fertility Outcomes (MedDietIVF)

2017년 2월 13일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (실제)

250

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Attiki
      • Athens, Attiki, 그리스, 10676
        • Harokopio University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Subfertile couples undergoing IVF treatment at a Fertility Clinic in Athens

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Live Birth
기간: 9 months
Birth of a neonate on or after 24 weeks gestation
9 months

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Nikolaos Yiannakouris, PhD, Associate Professor of Physiology

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2013년 6월 1일

기본 완료 (실제)

2016년 9월 1일

연구 완료 (실제)

2016년 12월 1일

연구 등록 날짜

최초 제출

2017년 2월 3일

QC 기준을 충족하는 최초 제출

2017년 2월 8일

처음 게시됨 (실제)

2017년 2월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 2월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 2월 13일

마지막으로 확인됨

2017년 2월 1일

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