Clinical Trials Directory

Trials / Completed

CompletedNCT02381821

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

Status
Completed
Phase
Study type
Observational
Enrollment
82 (actual)
Sponsor
Cairo University · Academic / Other
Sex
Female
Age
19 Years – 39 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
OTHER3 D ultrasound and Doppler examinationEndometrial 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
DRUGGnRH agonistAll 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

Timeline

Start date
2016-01-01
Primary completion
2017-12-03
Completion
2017-12-31
First posted
2015-03-06
Last updated
2018-01-03

Source: ClinicalTrials.gov record NCT02381821. Inclusion in this directory is not an endorsement.