InfertilityNCT02393235
A Comparative Analysis of Arterial Blood Flow in Unexplained Infertility, Tubal Infertility and Fertile Groups
An observational study of Infertility, run by Suleymaniye Birth And Women's Health Education And Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- doppler ultrasonography
- How many people
- 217 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women received infertility treatment
Who may be able to join
- unsuccessful infertility treatment
- normal prolactin levels
- normal thyroid stimulation hormone levels
- no ovarian or pelvic surgery history
Who cannot join
- To have systemic diseases
- receive medical treatments which may influence the clearance or excretion of gonadotropins and sex steroids
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleymaniye Birth And Women's Health Education And Research Hospital
Istanbul, 34020
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility
- Being tested
- doppler ultrasonography
- Keywords
- unexplained infertility, tubal infertility, pulsatility index, resistance index, fertile women
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doppler ultrasonographyOther
Ovarian, uterine and spiral artery pulsatility index and resistance index will measure
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: doppler ultrasonography | |
| 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) Receives: Other: doppler ultrasonography | |
| 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) Receives: Other: doppler ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2-3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleymaniye Birth And Women's Health Education And Research Hospital
- Sponsor type
- Other government
- Collaborators
- Bagcilar Training and Research Hospital
- Responsible party
- Sponsor
- Investigators
- Ali G Zebitay, M.D., Principal investigator, Suleymaniye Birth And Women's Health Education And Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393235
- Sponsor's protocol ID
- AGZ1-UN-DOP
- Status last verified
- Jul 2015
- First submitted
- 9 Mar 2015
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of Ovarian, Uterine and Spiral Arterial Blood Flow in Unexplained Infertility, Tubal Infertility and Fertile Groups
- ClinicalTrials.gov ID
- NCT02393235
- Acronym / sponsor ID
- AGZ1-UN-DOP
- Conditions
- Infertility
- Keywords
- unexplained infertility, tubal infertility, pulsatility index, resistance index, fertile women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Suleymaniye Birth And Women's Health Education And Research HospitalOther government
- Collaborators
- Bagcilar Training and Research Hospital
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| unexplained infertility(n:75) | – | Other: doppler ultrasonographyOvarian, uterine and spiral artery pulsatility index and resistance index will measure with doppler ultrasonography in the mid-luteal phase. ( 21th day) |
| tubal infertility(n:75) | – | Other: doppler ultrasonographyOvarian, uterine and spiral artery pulsatility index and resistance index will measure with doppler ultrasonography in the mid-luteal phase. ( 21th day) |
| fertile group(n:75) | – | Other: doppler ultrasonographyOvarian, uterine and spiral artery pulsatility index and resistance index will measure with doppler ultrasonography in the mid-luteal phase. ( 21th day) |
Who may qualify
- Ages
- 22 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women received infertility treatment
Key inclusion criteria (4 listed)
- unsuccessful infertility treatment
- normal prolactin levels
- normal thyroid stimulation hormone levels
- no ovarian or pelvic surgery history
Key exclusion criteria (2 listed)
- To have systemic diseases
- receive medical treatments which may influence the clearance or excretion of gonadotropins and sex steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doppler ultrasonographyOvarian, uterine and spiral artery pulsatility index and resistance index will measure | Other | fertile group(n:75), tubal infertility(n:75), unexplained infertility(n:75) |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali G Zebitay, M.D. principal investigator
Suleymaniye Birth And Women's Health Education And Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Suleymaniye Birth And Women's Health Education And Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.