- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02393235
A Comparative Analysis of Arterial Blood Flow in Unexplained Infertility, Tubal Infertility and Fertile Groups
July 2, 2015 updated by: Suleymaniye Birth And Women's Health Education And Research Hospital
A Comparative Analysis of Ovarian, Uterine and Spiral Arterial Blood Flow in Unexplained Infertility, Tubal Infertility and Fertile Groups
Factors affecting the success of the treatment of infertility can evaluate before and after embryo transfer in two stages.
Most of the patients reach the embryo transfer stage.
Unfortunately, the investigators are able to intervene very few of the factors that will affect the success of the post-transfer.
All factors and treatments that affect the implantation is vital to identify.
Basically, healthy vasculature is essential for a successful implantation.
The investigators will try to understand relationship between vascular resistance and type of infertility.
The investigators will examine whether the effect of the ovarian uterine and spiral artery resistance over infertility.
Study Overview
Detailed Description
In this study the investigators will examine whether the alterations of doppler indices in the uterine, ovarian and spiral arteries can help to explain tubal or unexplained infertility as a standard screening method.
Patients in unexplained-tubal infertility groups were treated in our IVF clinic.
Patients will be invited to the hospital according to the criteria of the study.
Fertile patients will be selected according to the criteria for patients who have come for the annual smear control.
The study hypothesis is that the resistance in ovarian, uterine and spiral artery doppler will be higher in cases with tubal and unexplained infertility as opposed to low resistance in fertile women.Ovarian, uterine and spiral artery pulsatility index (PI = (peak systolic velocity - end diastolic velocity) / time averaged velocity and resistance index ( RI= (peak systolic velocity - end diastolic velocity) / peak systolic velocity ) will measure with doppler ultrasonography in the mid-luteal phase ( 21th day).
Measured values are to be compared.
Study Type
Observational
Enrollment (Actual)
217
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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Istanbul, Turkey, 34020
- Suleymaniye Birth And Women's Health Education And Research Hospital
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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
22 years to 37 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Women received infertility treatment
Description
Inclusion Criteria:
- unsuccessful infertility treatment
- normal prolactin levels
- normal thyroid stimulation hormone levels
- no ovarian or pelvic surgery history
Exclusion Criteria:
- To have systemic diseases
- receive medical treatments which may influence the clearance or excretion of gonadotropins and sex steroids
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
unexplained infertility(n:75)
Ovarian, uterine and spiral artery pulsatility index and resistance index will measure with doppler ultrasonography in the mid-luteal phase.
( 21th day)
|
Ovarian, uterine and spiral artery pulsatility index and resistance index will measure
|
tubal infertility(n:75)
Ovarian, uterine and spiral artery pulsatility index and resistance index will measure with doppler ultrasonography in the mid-luteal phase.
( 21th day)
|
Ovarian, uterine and spiral artery pulsatility index and resistance index will measure
|
fertile group(n:75)
Ovarian, uterine and spiral artery pulsatility index and resistance index will measure with doppler ultrasonography in the mid-luteal phase.
( 21th day)
|
Ovarian, uterine and spiral artery pulsatility index and resistance index will measure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome measure of this study is to evaluate the possible difference in ovarian artery impedance to blood flow ( RI and PI) among unexplained infertility, tubal infertility and fertile group.
Time Frame: 2-3 month
|
2-3 month
|
The primary outcome measure of this study is to evaluate the possible difference in uterine artery impedance to blood flow (RI and PI) among unexplained infertility, tubal infertility and fertile group.
Time Frame: 2-3 month
|
2-3 month
|
The primary outcome measure of this study is to evaluate the possible difference in spiral artery impedance to blood flow ( RI and PI) among unexplained infertility, tubal infertility and fertile group.
Time Frame: 2-3 month
|
2-3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ali G Zebitay, M.D., Suleymaniye Birth And Women's Health Education And Research Hospital
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
March 1, 2015
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
March 18, 2015
First Posted (Estimate)
March 19, 2015
Study Record Updates
Last Update Posted (Estimate)
July 7, 2015
Last Update Submitted That Met QC Criteria
July 2, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGZ1-UN-DOP
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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