- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362061
3D Ultrasound Measurement of Junctional Zone Thickness and Its Relation to Implantation Success
March 22, 2017 updated by: Ahmed Maged, Cairo University
Thickness of the Junctional Zone Measured by 3D Ultrasound and Its Relation to the Success/Failure Implantation Rates in Assisted Reproduction Techniques
100 patients aged 21-40 years old, diagnosed as primary or secondary infertility .
These patients are then assigned to receive fertility treatment (ovulation induction, ICSI, intrauterine insemination and IVF).
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Cairo, Egypt, 12151
- Kasr Alainy Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
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 ).
Description
Inclusion Criteria:
- infertile women
Exclusion Criteria:
- congenital uterine anomalies medical disease contraindicating pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
pregnant
These patients are then assigned to receive fertility treatment (ovulation induction, ICSI, intrauterine insemination and IVF).
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 and they became pregnant
|
ultrasound to measure the thickness of the junctional zone at day 21 of the cycle
|
|
Non pregnant
These patients are then assigned to receive fertility treatment (ovulation induction, ICSI, intrauterine insemination and IVF).
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 and they remained non pregnant
|
ultrasound to measure the thickness of the junctional zone at day 21 of the cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
pregnancy rate
Time Frame: 14 days after evaluation
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14 days after evaluation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
healthy pregnancy
Time Frame: 6 weeks after pregnancy confirmation by pregnancy test
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6 weeks after pregnancy confirmation by pregnancy test
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
February 7, 2015
First Submitted That Met QC Criteria
February 11, 2015
First Posted (Estimate)
February 12, 2015
Study Record Updates
Last Update Posted (Actual)
March 24, 2017
Last Update Submitted That Met QC Criteria
March 22, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 128
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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