Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
NCT Number: NCT02416960
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.
Looking for future studies?
Notify Me18 year–35 year
Female
Interventional
Not applicable
Porto Alegre, Rio Grande do Sul, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle
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: baseline and 12 weeks
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
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
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
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: between 12 and 16 weeks, during the in vitro fertilization cycle
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
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 will be determined by the Embryonic Score Calculation - ESC, where embryos with score 4, are considered the best quality.
Hospital de Clinicas de Porto Alegre
Other
Effect of a Hypocaloric Diet With Different Glycemic Indexes on Ghrelin and Leptin Levels, Metabolic Parameters, and Reproductive Outcomes in Overweight and Obese Infertile Women: A Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01483612
Adnexal Diseases, Body Weight
Sherbrooke, Quebec, Canada
View Trial DetailsNCT02108665
Female Infertility, Female Urogenital Diseases
Nice, France
View Trial DetailsNCT07398924
Anovulatory Infertility, Female Infertility
Van, Di̇yarbakir, Turkey (Türkiye)
View Trial DetailsNCT06684951
Female Infertility, Female Urogenital Diseases
Baghdad, Iraq
View Trial Details