Back to resultsPredictors of Ovarian Reserve in Infertile Women
Primary Purpose
Ovarian Reserve
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
human menopausal gonadotropin
Sponsored by
About this trial
This is an interventional diagnostic trial for Ovarian Reserve focused on measuring predictors, ovarian reserve, infertile women
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.
Sites / Locations
- Kasr Alainy medical schoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
pregnant
Not pregnant
Arm Description
women with positive pregnancy test after induction of ovulation and ICSI
women with negative pregnancy test after induction of ovulation and ICSI
Outcomes
Primary Outcome Measures
positive pregnancy test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02896023
Brief Title
Predictors of Ovarian Reserve in Infertile Women
Official Title
Sonographic and Laboratory Predictors of Ovarian Reserve in Infertile Women
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Reserve
Keywords
predictors, ovarian reserve, infertile women
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pregnant
Arm Type
Active Comparator
Arm Description
women with positive pregnancy test after induction of ovulation and ICSI
Arm Title
Not pregnant
Arm Type
Active Comparator
Arm Description
women with negative pregnancy test after induction of ovulation and ICSI
Intervention Type
Drug
Intervention Name(s)
human menopausal gonadotropin
Other Intervention Name(s)
menogon
Intervention Description
Induction of ovulation followed by ICSI
Primary Outcome Measure Information:
Title
positive pregnancy test
Time Frame
14 days after embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Kasr Alainy medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Predictors of Ovarian Reserve in Infertile Women
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