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

Sponsor
Suleymaniye Birth And Women's Health Education And Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02393235
Collaborator
Bagcilar Training and Research Hospital (Other)
217
1
3
71.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: doppler ultrasonography

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

Study Type:
Observational
Actual Enrollment :
217 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Comparative Analysis of Ovarian, Uterine and Spiral Arterial Blood Flow in Unexplained Infertility, Tubal Infertility and Fertile Groups
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm 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)

Other: doppler ultrasonography
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)

Other: doppler ultrasonography
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)

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

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

  3. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 37 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Suleymaniye Birth And Women's Health Education And Research Hospital Istanbul Turkey 34020

Sponsors and Collaborators

  • Suleymaniye Birth And Women's Health Education And Research Hospital
  • Bagcilar Training and Research Hospital

Investigators

  • Principal Investigator: Ali G Zebitay, M.D., Suleymaniye Birth And Women's Health Education And Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suleymaniye Birth And Women's Health Education And Research Hospital
ClinicalTrials.gov Identifier:
NCT02393235
Other Study ID Numbers:
  • AGZ1-UN-DOP
First Posted:
Mar 19, 2015
Last Update Posted:
Jul 7, 2015
Last Verified:
Jul 1, 2015
Keywords provided by Suleymaniye Birth And Women's Health Education And Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2015