Clinical trial NCT02896023: Predictors of Ovarian Reserve in Infertile Women
Official title: Sonographic and Laboratory Predictors of Ovarian Reserve in Infertile Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ovarian Reserve
Keywords: predictors
ovarian reserve
infertile women
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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)

Eligibility criteria: 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.

Primary outcomes:
measure: positive pregnancy test
timeFrame: 14 days after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References: