Endometrial Volume and Sub-endometrial Vascularity 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.

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Key information

Conditions

Reproductive Techniques, Assisted Behavior Helping Behavior Social Behavior

Age range

19 year–39 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3 D ultrasound and Doppler examination

Other

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

GnRH agonist

Drug

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

Primary outcomes

pregnancy rate

Time frame: 14 days after embryo transfer

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Measurement of Endometrial Volume and Sub-endometrial Vascularity to Replace the Traditional Endometrial Thickness as Predictors of In-vitro Fertilization Success

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Mar 6, 2015
Registry last updated: Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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