Infertility Clinical Trial
— MedDietIVFOfficial title:
Association of the Mediterranean Diet With Fertility Outcomes: a Study Among Couples Undergoing in Vitro Fertilization Treatment
Verified date | February 2017 |
Source | Harokopio University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | December 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Greece | Harokopio University | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
Harokopio University | Embryogenesis Assisted Conception Unit |
Greece,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Live Birth | Birth of a neonate on or after 24 weeks gestation | 9 months | |
Secondary | Hormonal profile | Baseline serum E2, anti-mullerian hormone, inhibin b, luteinizing hormone, follicle stimulating hormone concentrations. | 3 months | |
Secondary | Oocyte number. | Total Number of oocytes produced. | 3 months | |
Secondary | Oocyte quality. | 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 | |
Secondary | Embryo number. | Total Number of embryos produced. | 3 months | |
Secondary | Embryo quality. | 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 | |
Secondary | Semen volume. | Ejaculate volumes will be estimated by specimen weight, assuming a semen density of 1.0 g/ml. | 1 month. | |
Secondary | Semen concentration. | Sperm concentration will be evaluated by hemocytometer Motility will be assessed in accordance with the World Health Organization 2010 criteria | 1 month. | |
Secondary | Semen morphology. | 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. | |
Secondary | Semen Motility. | 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. | |
Secondary | Fertilization rate | 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 | |
Secondary | Serum Adiponectin | 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 | |
Secondary | Follicular Fluid Adiponectin | Follicular fluid adiponectin levels from the dominant oocyte will be measured by ELISA method. | 6 months | |
Secondary | Follicular Fluid Follistatin, | Follicular fluid follistatin levels from the dominant oocyte will be measured by ELISA method. | 6 months | |
Secondary | Clinical Pregnancy | Elevation in b-human chorionic gonadotropin with the confirmation of an intrauterine pregnancy by ultrasound, first performed at 6 weeks of gestation | 6 months |
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