Predictors of Ovarian Reserve in Infertile Women

Ovarian Reserve Clinical Trial

Official title: Sonographic and Laboratory Predictors of Ovarian Reserve in Infertile Women

Status Recruiting

Clinical Trial 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)

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Infertility
• Ovarian Reserve

• NCT number: NCT02896023
• Study type: Interventional
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: 01005227404
• Email: prof.ahmedmaged@gmail.com
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2016
• Completion date: March 2020