A Comparative Analysis of Arterial Blood Flow in Unexplained Infertility, Tubal Infertility and Fertile Groups

Infertility Clinical Trial

Official title:

A Comparative Analysis of Ovarian, Uterine and Spiral Arterial Blood Flow in Unexplained Infertility, Tubal Infertility and Fertile Groups

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393235
• Other study ID #: AGZ1-UN-DOP
• Status: Completed
• Phase: N/A
• First received: March 9, 2015
• Last updated: July 2, 2015
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Suleymaniye Birth And Women's Health Education And Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 37 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• doppler ultrasonography
Ovarian, uterine and spiral artery pulsatility index and resistance index will measure

Locations

Country	Name	City	State
Turkey	Suleymaniye Birth And Women's Health Education And Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Suleymaniye Birth And Women's Health Education And Research Hospital	Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2-3 month	No
Primary	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.		2-3 month	No
Primary	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.		2-3 month	No