Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effects of an Intensive Lifestyle Intervention on Reproductive Outcomes in Obese, Subfertile Women
Brief Summary: This is a study to determine whether a low calorie diet using meal replacement shakes compared to current counseling about diet, followed by 3 cycles of clomiphene citrate (if needed) will result in: 1) improvements in ability to ovulate and achieve pregnancy either spontaneously or during 3 clomiphene citrate cycles 2) greater weight loss with reductions in waist and hip circumferences and improvements in hormones that are involved in allowing pregnancy to occur and hormones that are involved in metabolism, such as insulin and glucose (sugar) 3) improvements in other health conditions such as blood pressure, and emotional and physical well-being.

Women eligible to participate will be between the ages of 18-35 with a BMI (ratio of weight in kg divided by height in m2) of ≥ 35≤45 kg/m2 who are seeking help for anovulatory infertility including women with a diagnosis of polycystic ovarian syndrome (PCOS).


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:

* 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
C: 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
D: Inclusion Criteria:

* Women between the age of 18 and 39 years inclusive.
* Anovulatory infertility of duration at least 12 months.
* Polycystic ovary syndrome, based on Rotterdam consensus criteria.
* Normal serum prolactin, thyroid function and 17-hydroxyprogesterone.
* Normal serum prolactin, thyroid function and 17-hydroxyprogesterone;

Exclusion Criteria:

* Presence of any other significant infertility factor including male factor, known tubal disease or history of an ectopic pregnancy, known endometriosis affecting the fallopian tubes or ovaries.
* Already taking oral hypoglycaemics.
* Diabetics receiving treatment.
* Renal impairment
* Chronic hepatic disease
* Cardiac Disease
* Alcohol dependency
* Pre-disposition to lactic acidosis
* Previous ovarian drilling procedure, gonadotrophin injection therapy, IUI (intrauterine insemination) or IVF ( in vitro fertilisation).
* For those women who have had previous fertility treatment, the following would be excluded:

  * Women who have had \> 5 cycles of clomiphene citrate
  * Women who have had \> 5 months metformin treatment previously
  * Women who have proven to be resistant to 100mg or more of clomiphene citrate.

Answer: A