Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2016-09-30
2020-03-31
Brief Summary
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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)
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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pregnant
women with positive pregnancy test after induction of ovulation and ICSI
human menopausal gonadotropin
Induction of ovulation followed by ICSI
Not pregnant
women with negative pregnancy test after induction of ovulation and ICSI
human menopausal gonadotropin
Induction of ovulation followed by ICSI
Interventions
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human menopausal gonadotropin
Induction of ovulation followed by ICSI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
39 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed M Maged, MD
Assistant professor
Principal Investigators
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Ahmed Maged, MD
Role: PRINCIPAL_INVESTIGATOR
Kasr Alainy medical school
Locations
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Kasr Alainy medical school
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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154
Identifier Type: -
Identifier Source: org_study_id
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