Predictors of Ovarian Reserve in Infertile Women

Ovarian Reserve Clinical Trial

Official title:

Sonographic and Laboratory Predictors of Ovarian Reserve in Infertile Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02896023
• Other study ID #: 154
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: March 2020

Study information

• Verified date: September 2019
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: 01005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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)

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

• less than 39 years old,

• normal menstrual cycle with a range of 24 to 35 days

• normal seum prolactin.

• normal uterine cavity determined by previous hysterosalpingography or hysteroscopy

Exclusion Criteria:

• smokers

• endometriosis

• Women with endometriosis;

• abnormal endocrine functions such as diabetes mellitus, thyroid disorders, and adrenal abnormalities; general diseases, those with ovarian cysts, or those who have azospermia partners.

Related Conditions & MeSH terms

• Infertility
• Ovarian Reserve

Intervention

Drug:
• human menopausal gonadotropin
Induction of ovulation followed by ICSI

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive pregnancy test		14 days after embryo transfer