Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients Undergoing IVF Treatment.
Brief Summary: Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual irregularity and hyperandrogenism and is the most common cause of oligoovulatory infertility. Insulin resistance with resulting hyperinsulinemia is also common among women with PCOS, along with increased risk for dyslipidemia, hypertension, diabetes and related cardiovascular consequences. Resveratrol is a natural polyphenol with anti-carcinogenic, anti-proliferative and pro-apoptotic properties, that has been shown to decrease proliferation and steroidogenesis in theca cells, emerging as a potential therapeutic agent in PCOS patients. However, little is known about its potential beneficial effect on oocyte quality as well as other reproductive outcomes, such as implantation an pregnancy rates. The present study evaluates effects of resveratrol on selected biochemical parameters and reproductive outcome among patients with PCOS who undergo in vitro fertilization (IVF).


Options:
A: Inclusion Criteria:Couple

* 12 or more months of infertility (primary or secondary)
* Heterosexual
* Cohabitating and able to have regular intercourse

Male:

* ≥ 18 years of age
* At least one abnormal semen parameter on a semen analysis within the past 6 months:

  * Sperm concentration ≤15 Million/ml
  * Total motility ≤40%
  * Normal morphology (Kruger) ≤4%
  * DNA fragmentation (SCSA, DNA fragmentation index) \>25%

Female:

* ≥18 years of age and ≤40 years of age
* For women ≥ 35 years of age, evidence of normal ovarian reserve as assessed by menstrual cycle day 3 (+/-2 days) FSH ≤10 IU/L with estradiol ≤ 70 pg/mL, AMH ≥ 1.0 ng/mL, OR antral follicle count \>10 within one year prior to study initiation.
* Evidence of at least one patent fallopian tube as determined by an hysterosalpingogram or laparoscopy showing at least one patent fallopian tube or a saline infusion sonogram showing spillage of contrast material
* Regular cycles defined as ≥25 days and ≤35 days in duration
* Evidence of ovulation including biphasic basal body temperatures, positive ovulation predictor kits, or progesterone level ≥3 ng/ml.

Exclusion Criteria:

* Couple:

  * Previous sterilization procedures (vasectomy, tubal ligation). The prior procedure may affect study outcomes.
  * Planning in vitro fertilization in the next 6 months

Male:

* Sperm concentration \< 5 million/mL on screening semen analysis
* Current use of a medication or drug that would affect reproductive function or metabolism (see Appendix C for list)
* Current multivitamin or herb use (requires 1 month wash-out)
* Current serious medical illnesses, such as cancer, heart disease, or cirrhosis
* Current use of anticoagulants
* Untreated hypothyroidism
* Uncontrolled diabetes mellitus

Female:

* History of surgically or medically confirmed moderate or severe endometriosis
* Body mass index \>35 kg/m2
* Currently pregnant
* History of polycystic ovarian syndrome
* Current serious medical illnesses, such as cancer, heart disease, or cirrhosis
* History of systemic chemotherapy or pelvic radiation
* Current use of a medication or drug that would affect reproductive function or metabolism
B: Inclusion Criteria:

* Male with an age \> 18 years old
* Referred for male infertility with sperm concentration \>= 0.01 million/ml. Additionally, all men must have either sperm concentration \< 20 million/ml or \< 50% progressive motile spermatozoa or \< 12% morphological normal spermatozoa using strict criteria

Exclusion Criteria:

* Men with chronic diseases (such as diabetes mellitus, Thyroid disease, endocrine disturbances in need of treatment, malignant disease, or diseases known to interfere with VD intake or very sensitive to VD intake (such as inflammatory disease with granuloma: sarcoidoses, tuberculosis, Wegeners, vasculitis, inflammatory bowel disease (Crohn's and colitis ulcerosa etc).
* Men with present or previous malignant disease
* If there is an indication for testis biopsy and it is planned or conducted within the next 6 months
* Serum 25-hydroxy-D3 \> 50 nmol/l at the time of inclusion
* Serum Calcium ion \> 1,35 mmol/l
* Inhibin-B \< 30 pg/ml
* Intake of vitamin D above 15 ug daily
* Allergy towards vitamin D or arachidis oil (peanuts)
* Men with total or partly obstructive oligospermia and men who had vasectomy performed

Criteria for drop out:

* Abrogation of the treatment
* Newly diagnosed endocrine, calcium metabolic disease, parathyroid, thyroid, diabetes or other endocrine disease in need of treatment
* New malignant disease
* Treatment with chemotherapy, immunomodulating therapy, salazopyrin
* Oral or iv treatment with steroid hormones
* Treatment with diuretics, antihypertensive treatment, treatment the heart, calcium channel blockers
* Development of vitamin d intoxication
* If testis biopsy is performed or other surgery in the genital region during the trial
C: Inclusion Criteria:

* Women aged from 18 to 40 years old.
* PCOS diagnosis (according to Rotterdam criteria).
* Mild or moderate male factor, tubal factor or unknown infertility.

Exclusion Criteria:

* Follicle stimulation hormone (third of day of menstruation) \> 10 milli international units/L.
* Endometriosis (III o IV).
* Congenital adrenal hyperplasia.
* Cushing syndrome.
* Hyperprolactinemia.
* Thyroid disease.
* Androgenic hormone secretor tumors.
* Patients included in this trial did not take either oral contraceptives, steroids or other medications that could modify the ovarian function, insulin sensitivity or lipid metabolism 3 months before the onset of the trial.
* Severe male factor (sperm concentration \< 5 mill/ml).
* Patients undergoing oocyte vitrification to avoid hyperstimulation syndrome will be excluded.
D: Inclusion Criteria:

* All women initiating IVF treatment

Exclusion Criteria:

* Women that have entered the study before

Answer: C