Infertility has been currently recognized as a disorder related to obesity. Among several metabolic changes associated with obesity, insulin resistance appears to be linked to hormonal disorders that affect reproductive system. Leptin and ghrelin are hormones involved in energy balance regulation and are also associated with reproductive system regulation, but its relationship with infertility is scarce. The aim of this study is to determine the effect of a hypocaloric diet with different glycemic indexes on ghrelin and leptin levels, hormonal, metabolic and reproductive parameters in infertile overweight or obese women candidates to in vitro fertilization. The patients who meet the inclusion criteria and accept to participate in the study, will be allocated in one of the following groups: Hypocaloric Low Glycemic Index diet group; Hypocaloric Conventional diet group or Control group (maintenance of usual diet) and follow the study protocol for 12 week. Immediately after the end of the diet protocol, the patients will be submitted to the in vitro fertilization treatment.
Infertility has been currently recognized as a disorder related to obesity. Among several metabolic changes associated with obesity, insulin resistance appears to be linked to hormonal disorders that affect reproductive system. Leptin and ghrelin are hormones involved in energy balance regulation and are also associated with reproductive system regulation, but its relationship with infertility is scarce. The aim of this study is to determine the effect of a hypocaloric diet with different glycemic indexes on ghrelin and leptin levels, hormonal, metabolic and reproductive parameters in infertile overweight or obese women candidates to in vitro fertilization. Infertile women with grade I and II obesity, or pre-obesity with increased waist circumference will be recruited. Patients will be assigned to Hypocaloric Low Glycemic Index diet group; Hypocaloric Conventional diet group or Control group (maintenance of usual diet), and will follow the protocol for 12 weeks. The two intervention diets will be similar in terms of caloric intake and macronutrient distribution and different in terms of carbohydrates quality (index and glycemic load). Immediately after the end of the diet protocol, the patients will be submitted to the in vitro fertilization treatment. Before and after the intervention anthropometric measurements (weight, height, body mass index, waist and hip circumference) and body composition (body fat percentage determined by the measurement of seven skinfolds) will be evaluated as well as biochemical parameters: leptin, acylated ghrelin, glucose, insulin, serum lipids (total cholesterol and lipoproteins, and triglycerides), sex hormones - follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, prolactin, testosterone and sex hormone binding globulin (SHBG). Primary outcome: clinical pregnancy rate. Secondary outcomes: HOMA-IR (Homeostasis Model Assessment), acylated ghrelin and leptin levels, body fat percentage, number of oocytes retrieved, percentage of fertilized oocytes and embryo quality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
This diet will be designed as a moderate reduced-energy, moderate-to-high fiber, low glycemic index/load diet.
This diet will be designed as a moderate reduced-energy, moderate-to-high fiber, high glycemic index/load diet.
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Clinical Pregnancy Rate
Clinical Pregnancy will be considered as pregnancy diagnosed by ultrasound visualization of one or more gestational sacs or definitive clinical signs of pregnancy.
Time frame: up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle
HOMA-IR index (Homeostasis Model Assessment)
The HOMA-IR index will be obtained by the following formula: fasting glucose (mg/dl/18) x fasting insulin (U/mL)/22.5.
Time frame: baseline and 12 weeks
Acylated Ghrelin Levels (pg/dL)
The levels of acylated ghrelin will be determined by enzyme immunoassay (SPI BIO, Montigny le Bretonneux, France) using a plate reader (Biochrom Anthos MultiRead 400, Biochrom Ltd., Cambridge, UK).
Time frame: baseline and 12 weeks
Leptin Levels (ng/mL)
The levels of leptin will be determined by enzyme immunoassay (SPI BIO, Montigny le Bretonneux, France) using a plate reader (Biochrom Anthos MultiRead 400, Biochrom Ltd., Cambridge, UK).
Time frame: baseline and 12 weeks
Body Fat Percentage (%)
The body fat percentage will be determined measuring the skinfolds at seven sites (triceps, subscapular, suprailiac, axillary, pectoral, abdomen and thigh) using a standardized technique of measurement and determination.
Time frame: baseline and 12 weeks
Number of Oocytes Retrieved
Women will follow a pre-established protocol of ovarian stimulation as part of the preparation for the in vitro fertilization cycle. The evolution of oocytes development will be accompanied by the medical team using the ultrasound technique and when at least one oocyte reach the average size of 17 mm the puncture of oocytes by aspiration will be held.
Time frame: between 12 and 16 weeks, during the in vitro fertilization cycle
Percentage of Fertilized Oocytes (%)
The percentage of fertilized oocytes will be obtained using the following formula: number of embryos/ total number of oocytes x 100.
Time frame: between 12 and 16 weeks, during the in vitro fertilization cycle
Embryo Quality
Embryo quality will be determined by the Embryonic Score Calculation - ESC, where embryos with score 4, are considered the best quality.
Time frame: between 12 and 16 weeks, during the in vitro fertilization cycle
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