Association of the Mediterranean Diet With Fertility Outcomes (MedDietIVF)
Association of the Mediterranean Diet With Fertility Outcomes: a Study Among Couples Undergoing in Vitro Fertilization Treatment
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Attiki
-
Athens、Attiki、ギリシャ、10676
- Harokopio University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Live Birth
時間枠:9 months
|
Birth of a neonate on or after 24 weeks gestation
|
9 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hormonal profile
時間枠:3 months
|
Baseline serum E2, anti-mullerian hormone, inhibin b, luteinizing hormone, follicle stimulating hormone concentrations.
|
3 months
|
|
Oocyte number.
時間枠:3 months
|
Total Number of oocytes produced.
|
3 months
|
|
Oocyte quality.
時間枠: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.
時間枠:3 months
|
Total Number of embryos produced.
|
3 months
|
|
Embryo quality.
時間枠: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.
時間枠:1 month.
|
Ejaculate volumes will be estimated by specimen weight, assuming a semen density of 1.0 g/ml.
|
1 month.
|
|
Semen concentration.
時間枠: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.
時間枠: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.
時間枠: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
時間枠: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
時間枠: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
時間枠:6 months
|
Follicular fluid adiponectin levels from the dominant oocyte will be measured by ELISA method.
|
6 months
|
|
Follicular Fluid Follistatin,
時間枠:6 months
|
Follicular fluid follistatin levels from the dominant oocyte will be measured by ELISA method.
|
6 months
|
|
Clinical Pregnancy
時間枠: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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Nikolaos Yiannakouris, PhD、Associate Professor of Physiology
出版物と役立つリンク
一般刊行物
- Karayiannis D, Kontogianni MD, Mendorou C, Douka L, Mastrominas M, Yiannakouris N. Association between adherence to the Mediterranean diet and semen quality parameters in male partners of couples attempting fertility. Hum Reprod. 2017 Jan;32(1):215-222. doi: 10.1093/humrep/dew288. Epub 2016 Nov 14.
- Karayiannis D, Kontogianni MD, Mendorou C, Mastrominas M, Yiannakouris N. Adherence to the Mediterranean diet and IVF success rate among non-obese women attempting fertility. Hum Reprod. 2018 Mar 1;33(3):494-502. doi: 10.1093/humrep/dey003.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。