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Investigation of U1-A Uterine Anomalies Implantation Markers From the Lateral Walls of the Endometrium

Primary Purpose

T-Shaped Uterus, Infertility, Female, Genital Tract Anomalies

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)
Sponsored by
Ufuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T-Shaped Uterus focused on measuring T-Shaped Uterus, Infertility, Female, Intregrin Beta 3, Genital Tract Anomalies

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18-45 age,
  2. Have no systemic disease,
  3. ESGE U1-A having uterine anomaly,
  4. Primary infertile, recurrent implantation loss, recurrent pregnancy loss history,
  5. Not having previous uterine surgery.

Exclusion Criteria:

  1. Patients over the age of 45 under the age of 18,
  2. Those with systemic disease (Hypertension, Heart Disease, Asthma, Renal Disease, Liver Disease, Epilepsy),
  3. Having previous uterine surgery,
  4. Those who gave birth.

Sites / Locations

  • Ufuk UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)

Arm Description

With the bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen. Germany), a single incision was made from the bottom of the ostium onto the lateral walls up to the isthmus, with both lateral horns perpendicular to myometrium. The depth of the incision was between 5 and 7 mm.

Outcomes

Primary Outcome Measures

Comparison of endometrial lateral wall biopsies before and after hysteroscopic metroplasty in patients with T-shaped uterus.
From the endometrium biopsies taken before and after the operation, the implantation marker beta 3 integrin was examined to determine if there was any change in the implantation.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2020
Last Updated
November 24, 2020
Sponsor
Ufuk University
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1. Study Identification

Unique Protocol Identification Number
NCT04501003
Brief Title
Investigation of U1-A Uterine Anomalies Implantation Markers From the Lateral Walls of the Endometrium
Official Title
Investigation of Implantation Markers of Anomalies Classified as U1-A Uterine According to ESHRE/ESGE Classification of Female Genital Tractus Anomalies in Biopsy Specimens Obtained From the Lateral Walls of the Endometrium
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ufuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Various types and classes of uterine malformations have been identified and the ESHRE / ESGE classification system has recently been published on female genital system anomalies. Postoperative positive pregnancy results were obtained in studies conducted in patients with infertility, recurrent implantation failure, and recurrent pregnancy loss, which were not previously described in T-shaped uterine anomalies. Considering the increase in endometrial gland and vascularity after the surgical procedure performed in these patients, our primary goal in our study is to compare the number of implantation markers (αVβ3 integrin) and subepithelial glands in the specimen biopsies taken from the lateral walls of the endometrium before and after hysteroscopic surgery in patients with class U1a anomalies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-Shaped Uterus, Infertility, Female, Genital Tract Anomalies
Keywords
T-Shaped Uterus, Infertility, Female, Intregrin Beta 3, Genital Tract Anomalies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)
Arm Type
Other
Arm Description
With the bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen. Germany), a single incision was made from the bottom of the ostium onto the lateral walls up to the isthmus, with both lateral horns perpendicular to myometrium. The depth of the incision was between 5 and 7 mm.
Intervention Type
Device
Intervention Name(s)
Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)
Intervention Description
With the bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen. Germany), a single incision was made from the bottom of the ostium onto the lateral walls up to the isthmus, with both lateral horns perpendicular to myometrium. The depth of the incision was between 5 and 7 mm. The cavity was widened to be triangular and symmetrical. Both tubal ostium surgeries were clearly observed at the end of the surgery. All patients were discharged on the day of surgery and no hormonal therapy and intrauterine balloon was applied after surgery. Approximately 3 months after the hysteroscopic T-shaped operation, an office hysteroscopy operation was planned to control patients in the secretory phase, to perform uterine cavity and post-operative fly control and to receive post-operative control endometrial biopsy specimens.
Primary Outcome Measure Information:
Title
Comparison of endometrial lateral wall biopsies before and after hysteroscopic metroplasty in patients with T-shaped uterus.
Description
From the endometrium biopsies taken before and after the operation, the implantation marker beta 3 integrin was examined to determine if there was any change in the implantation.
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-45 age, Have no systemic disease, ESGE U1-A having uterine anomaly, Primary infertile, recurrent implantation loss, recurrent pregnancy loss history, Not having previous uterine surgery. Exclusion Criteria: Patients over the age of 45 under the age of 18, Those with systemic disease (Hypertension, Heart Disease, Asthma, Renal Disease, Liver Disease, Epilepsy), Having previous uterine surgery, Those who gave birth.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sezin Oral Yıldız, M.D.
Phone
+905374459898
Email
drsezinoral@gmail.com
Facility Information:
Facility Name
Ufuk University
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
21705770
Citation
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Investigation of U1-A Uterine Anomalies Implantation Markers From the Lateral Walls of the Endometrium

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