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UnknownNCT02896023

Predictors of Ovarian Reserve in Infertile Women

Sonographic and Laboratory Predictors of Ovarian Reserve in Infertile Women

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Cairo University · Academic / Other
Sex
Female
Age
20 Years – 39 Years
Healthy volunteers
Not accepted

Summary

Patients will be subjected to: A. Clinical evaluation including history and examination B. Ultrasonographic evaluation of Ovarian Morphometry: * Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only one examiner to avoid inter-observer variations. * Ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. Mean values of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3) × 0 .523} * Antral follicle count will be determined for each patient C. Laboratory Evaluation: Blood samples will be collected in the early follicular phase. Samples will be immediately centrifuged and serum saved at -20 degrees for measurement of: * Anti Mullerian Hormone (AMH) * Follicle Stimulating Hormone (FSH) * Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)

Detailed description

Patients will be subjected to: A. Clinical evaluation including history and examination B. Ultrasonographic evaluation of Ovarian Morphometry: * Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only one examiner to avoid inter-observer variations. * Ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. Mean values of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3) × 0 .523} * Antral follicle count will be determined for each patient C. Laboratory Evaluation: Blood samples will be collected in the early follicular phase. Samples will be immediately centrifuged and serum saved at -20 degrees for measurement of: * Anti Mullerian Hormone (AMH) * Follicle Stimulating Hormone (FSH) * Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)

Conditions

Interventions

TypeNameDescription
DRUGhuman menopausal gonadotropinInduction of ovulation followed by ICSI

Timeline

Start date
2016-09-01
Primary completion
2020-01-01
Completion
2020-03-01
First posted
2016-09-12
Last updated
2019-09-23

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT02896023. Inclusion in this directory is not an endorsement.