Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* Women
* 18 to 35 years old
* Obese(BMI of ≥35≤45 kg/m2)
* Infertility (12 months of unprotected intercourse without conception)
* Ovulatory dysfunction (amenorrhea, irregular cycles, or progesterone level less than 10 ng/mL in the luteal phase)
* Partner with semen analysis demonstrating at least 20 million sperm/mL, 50% motility, and normal morphology by Kruger criteria of 8%
* Evidence of normal uterine anatomy and at least on patent tube documented by hysterosalpingogram or saline infusion sonogram.
* Women with polycystic ovary syndrome

Exclusion Criteria:

* Significant heart disease (coronary artery disease, Class II-VI Heart Failure, arrythmia)
* Chronic Kidney Disease, Stage IV or greater
* Significant gastrointestinal tract diseases (e.g. IBD)
* Autoimmune disorders (e.g. systemic lupus erythematosus)
* Neurological (e.g. Multiple Sclerosis)
* Psychiatric disorders (Bipolar, Major Depression)
* History of or current eating disorders or substance abuse
* Endocrine disorders (Type 1 diabetes, adrenal, pituitary or uncontrolled thyroid disease)
* HIV/AIDS
* Significant anemia
* History of or current clotting disorder
* Cancer other than minor skin cancers
* Other conditions that would complicated pregnancy.
* Women will be excluded if they are taking anti-obesity drugs, or appetite suppressants within the last 2 months, or have had previous bariatric surgery.
* Women will be excluded if they have used hormonal medications within the last 2 months, previous use of ovulation induction medications, have endometriosis by American Fertility Society (AFS) class III or IV, have an FSH \> 10 IU/mL or couples using donor sperm or are already pregnant.
B: Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30 kg/m² or higher

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of MEN 2
* significant cardiovascular, kidney or hepatic disease
* the use of medications known or suspected to affect reproductive or metabolic functions
* the use of statins, within 90 days prior to study entry
C: Inclusion Criteria:

* Diagnose of female infertility and indication for treatment with in vitro fertilization
* Body Mass Index (BMI) equal or greater than 30 kg/m² or BMI \> 25 kg/m² with increased waist circumference (\> 80 cm);
* Being not treated (diet) for weight loss/gain and maintaining stable body weight in the three months prior to the study;
* Not having stomach/digestive problems
* Not having the knowledge of cardiovascular disease history;
* Non-smokers;
* Not using any medication.

Exclusion Criteria:

* Patients with BMI equal or higher than 40 kg/m² (morbid obesity)
* Patients who are already receiving some type of nutritional intervention
* Patients with co-morbidities that may interfere with reproductive capacity (genetic and/or endocrine disorders, diabetes mellitus, cancer, liver or kidney failure), alcoholics, individuals who have contact (work) with heavy metals or chemicals (exposure to solvents and pesticides)
* Lack of adherence to the proposed dietary treatment
D: Inclusion Criteria:

* Irregular menses, i.e. cyclus length of \>36 days
* Premenopausal
* Increased fasting insulin \> 50 pmol/l
* Increased free testosterone \> 0.035 nmol/l

Exclusion Criteria:

* Age: \<18 years
* Contraceptive pill within the past 3 months
* Postmenopausal (increased FSH)
* Known diabetes mellitus, endocrine disease or other disease requiring treatment
* Drug use
* Pregnancy
* Planned pregnancy during the treatment period
* Increased liver parameters

Answer: C