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:

* Infertile heterosexual couples about to start a first IVF-cycle (with or without ICSI) with infertility defined as the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse
* Women of couples aged ≤ 38 years
* Both partners possess a smartphone
* Both partners understand and speak Dutch
* Written informed consent after been informed on all aspects of the study

Exclusion Criteria:

* Couples with previous IVF/ICSI treatment cycles
* Couples where one of the partners has special dietary requirements including but not limited to patients that underwent bariatric surgery, patients with coeliac disease or renal disease
* Couples where one of the partners has specific movement's constraints including but not limited to patients with cerebral palsy or hemiparesis
* Couples starting IVF/ICSI with preimplantation genetic diagnosis (PGD)
* Couples using donor gametes or donor embryos
B: Inclusion Criteria:

All couples undergoing infertility treatment (in vitro fertilization or intracytoplasmic sperm injection) at the Department of Gynecologic Endocrinology and Fertility Disorders at Heidelberg University Women's Hospital, which have

* agreed to participate in the study
* indicated their mobile phone number
* sufficient knowledge of German language.

If one partner is refusing to participate, the other person may be admitted as an individual.

Exclusion Criteria:

* denial of participation
* non-existent smartphone
* insufficient knowledge of German language
C: Inclusion Criteria:

* All women initiating IVF treatment

Exclusion Criteria:

* Women that have entered the study before
D: 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

Answer: D