Endometrial Volume and Sub-endometrial Vascularity as Predictors of In-vitro Fertilization Success
The Measurement of Endometrial Volume and Sub-endometrial Vascularity to Replace the Traditional Endometrial Thickness as Predictors of In-vitro Fertilization Success
100 patients aged 21-40 years old, diagnosed as primary or secondary infertility These patients are then assigned to receive ICSI treatment (ovulation induction, . They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.
Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the junctional zone at day 21 of the cycle.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
100 patients aged 21-40 years old, diagnosed as primary or secondary infertility due to the following causes of infertility; ( Pelvic Inflammatory disease, dysovulation , tubal infertility, unexplained infertility, combined infertility or due to male factor ). These patients are then assigned to receive fertility treatment (ICSI) They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.
Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the junctional zone at day 21 of the cycle.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- A normal transvaginal ultrasound is defined as having no visible intracavitary pathology (e.g. submucous myomas, polyps or septa) and was be performed in the follicular phase of the menstrual cycle. Intramural myomas without impression or deformation of the uterine cavity were incorporated in the definition of a normal ultrasound
Exclusion Criteria:
- Exclusion criteria included Females aged above 40 years old , patients with endometriosis, abnormal endocrine functions as Diabetes mellitus, thyroid disorders and adrenal abnormalities ,general diseases, those with ovarian cysts or have azospermic partners
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
pregnant
women undergoing ICSI who became pregnant
|
Endometrial thickness was measured in the longitudinal plane at the widest anteroposterior diameter with a trans-vaginal 2D ultrasound, and then 3D mode was then activated with power Doppler setting for this study standardized using a frequency at 4-9 MHZ pulse repetition frequency at 0.5KHz gain at-3.0 and wall motion filter at 1.
The sub-endometrial region was considered to be within 3 mm of the originally defined myometrial-endometrial contour.
The endometrial volume (EV) and 3D power Doppler indices below the endometrium were measured using the automated VOCAL™ for the 3D power Doppler histogram analysis
All women received daily subcutaneous 0.1 mg triptorelin injection started from day 21) of the cycle preceding stimulation.
Downregulation of the pituitary gonadotropins was confirmed after 12 days , gonadotropin (Gn) induction was started using Human menopausal gonadotropins for ovarian stimulation.
The starting dose was 225 to 300 IU .
Ultrasound Folliculometry was done every other day .
When two or more follicles reached a minimum mean diameter of 18 mm, triggering of ovulation trigger was done using Human chorionic gonadotropin (hCG) 10,000 IU and ovum pick up was scheduled 36 hours later
|
|
Not pregnant
women undergoing ICSI who fail to achieve pregnancy
|
Endometrial thickness was measured in the longitudinal plane at the widest anteroposterior diameter with a trans-vaginal 2D ultrasound, and then 3D mode was then activated with power Doppler setting for this study standardized using a frequency at 4-9 MHZ pulse repetition frequency at 0.5KHz gain at-3.0 and wall motion filter at 1.
The sub-endometrial region was considered to be within 3 mm of the originally defined myometrial-endometrial contour.
The endometrial volume (EV) and 3D power Doppler indices below the endometrium were measured using the automated VOCAL™ for the 3D power Doppler histogram analysis
All women received daily subcutaneous 0.1 mg triptorelin injection started from day 21) of the cycle preceding stimulation.
Downregulation of the pituitary gonadotropins was confirmed after 12 days , gonadotropin (Gn) induction was started using Human menopausal gonadotropins for ovarian stimulation.
The starting dose was 225 to 300 IU .
Ultrasound Folliculometry was done every other day .
When two or more follicles reached a minimum mean diameter of 18 mm, triggering of ovulation trigger was done using Human chorionic gonadotropin (hCG) 10,000 IU and ovum pick up was scheduled 36 hours later
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
pregnancy rate
Time Frame: 14 days after embryo transfer
|
14 days after embryo transfer
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 127 (Tumor Vaccine Group)
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