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SHD_0516_Ovarian_COS
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SHD_0516_COS (IVF) [1]
Inclusion Criteria
- Females, age 22 to <46 years
- Under IVF or ovulation induction protocols that either have ≤4 oocytes retrieved or greater than 15 oocytes retrieved
- Both ovaries present
Exclusion Criteria
- Pregnant within past 3 months
- PCOS diagnosis following Rotterdam criteria of which 2 out of 3 criteria are met. 1. Oligo-anovulation and/or anovulation (ovarian dysfunction) or, 2. Excess androgen activity (clinical or biological hyperandrogenism) or, 3. Polycystic ovaries (antral follicle excess by gynecologic ultrasound with ≥12 follicles from 2 to 9 mm per ovary and/or ovarian volume ≥10 mL)
- subjects with major ovarian abnormalities, including: presence of only one ovary, cysts and solid masses > 2 cm, surgically confirmed endometrioma
- subjects with ovarian surgery within past 6 months
- subjects currently undergoing treatment for malignancy or positive hCG levels
- subjects on hormonal contraceptives within last 3 months
- subjects with BMI higher or equal to 40
SHD_0516_OvarianReserve (AFC) [2]
Inclusion Criteria
- Females, age 22 to <46 years
- Both ovaries present
- AFC determined on days 2-4 of menstrual cycles only
- AFC values less than or equal to 15, or above 15
Exclusion Criteria
- Pregnant within past 3 months
- PCOS diagnosis following Rotterdam criteria of which 2 out of 3 criteria are met. 1. Oligo-anovulation and/or anovulation (ovarian dysfunction) or, 2. Excess androgen activity (clinical or biological hyperandrogenism) or, 3. Polycystic ovaries (antral follicle excess by gynecologic ultrasound with ≥12 follicles from 2 to 9 mm per ovary and/or ovarian volume ≥10 mL) - Subjects with major ovarian abnormalities, including: presence of only one ovary, cysts and solid masses > 2 cm.
- Subjects with ovarian surgery within past 6 months
- Subjects with major endocrine or metabolic disorders, including: diabetes, pituitary, adrenal, pancreas, liver and kidney disease, hypothalamic disorders, high prolactin, congenital hyperplasia, premature ovarian failure and premature ovarian insufficiency.
- Subjects currently undergoing treatment for malignancy or positive hCG levels.
- Subjects on any hormonal medication in the past 21 days (thyroid hormones permitted).
- Subjects on hormonal contraceptives within last 3 months
- Subjects with BMI higher or equal to 40.
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