Clinical trial NCT02393235: A Comparative Analysis of Arterial Blood Flow in Unexplained Infertility, Tubal Infertility and Fertile Groups
Official title: A Comparative Analysis of Ovarian, Uterine and Spiral Arterial Blood Flow in Unexplained Infertility, Tubal Infertility and Fertile Groups
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: unexplained infertility
tubal infertility
pulsatility index
resistance index
fertile women
Lead sponsor: Suleymaniye Birth And Women's Health Education And Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Bagcilar Training and Research Hospital
First posted: 2015-03-19
Enrollment: 217
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women received infertility treatment

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 2-3 month
measure: 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.
timeFrame: 2-3 month
measure: 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.
timeFrame: 2-3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Suleymaniye Birth And Women's Health Education And Research Hospital
Study officials:
affiliation: Suleymaniye Birth And Women's Health Education And Research Hospital
name: Ali G Zebitay, M.D.
role: PRINCIPAL_INVESTIGATOR
References: