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Endometrial Injury In Recurrent Implantation Failure

Primary Purpose

Infertility, Endometrial Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Endometrial Injury with Hysteroscopy
Sponsored by
Gurgan Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Recurrent implantation failure, Endometrial injury, Implantation, Hysteroscopy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women under the age of 40 who met the RIF definition
  • Patients whose follicle-stimulating hormone (FSH) levels were ≤ 15 IU/mL

Exclusion Criteria:

  • Patients with congenital uterine anomalies
  • Patients with Asherman's syndrome
  • Patients with uterine cavity distorted by myoma or endometrial polyps
  • Patients with confirmed endometriosis or endometrioma
  • Patients with BMI of <18.5 and >29.9

Sites / Locations

  • Gurgan Clinic IVF and Women Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Injury group

Control group

Arm Description

Endometrial injury with hysteroscopy

No hysteroscopy

Outcomes

Primary Outcome Measures

Positive Pregnancy
Blood concentration of beta-hcg

Secondary Outcome Measures

Full Information

First Posted
November 14, 2018
Last Updated
January 13, 2019
Sponsor
Gurgan Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03748238
Brief Title
Endometrial Injury In Recurrent Implantation Failure
Official Title
Systematic And Standardized Hysteroscopic Endometrial Injury For Treatment Of Recurrent Implantation Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gurgan Clinic

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to investigate that the efficacy of the endometrial injury before IVF in recurrent implantation failure patients.
Detailed Description
This is a prospective and randomized controlled trial investigating the effect of hysteroscopic endometrial injury for treatment of recurrent implantation failure. Approximately 230 patients who had failed to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles to a woman under the age of 40 years will be randomized into two groups. Injury group will receive endometrial injury during their hysteroscopic procedure, whereas the control group (n=115) did not. This study will investigate that, whether the endometrial injury is beneficial in recurrent implantation failure patients to increase the odds of clinical pregnancy rates, live birth rates, and implantation rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Endometrial Diseases
Keywords
Recurrent implantation failure, Endometrial injury, Implantation, Hysteroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Injury group
Arm Type
Experimental
Arm Description
Endometrial injury with hysteroscopy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No hysteroscopy
Intervention Type
Procedure
Intervention Name(s)
Endometrial Injury with Hysteroscopy
Intervention Description
All office hysteroscopy procedures will be done transvaginally under sedation with a 5 mm 30 degree lens supplied with a 5 F working channel continuous flow office hysteroscope (Bettocchi office hysteroscope, Karl Storz, Tuttlingen, Germany) without speculum or tenaculum. Briefly, following cervical passage and initial endometrial cavity investigation endometrial injury will be performed without energy modality (i.e. with scissors). Endometrial injury will perform first on the fundus by cutting into the endometrium (without injuring the myometrium) transversally. Later, vertical incisions will perform 0,5 cm apart each other, on the anterior and posterior walls of the uterus, 1-1.5 cm away from the fundus and one cut for each lateral wall
Primary Outcome Measure Information:
Title
Positive Pregnancy
Description
Blood concentration of beta-hcg
Time Frame
1month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only women with recurrent implantation failure
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women under the age of 40 who met the RIF definition Patients whose follicle-stimulating hormone (FSH) levels were ≤ 15 IU/mL Exclusion Criteria: Patients with congenital uterine anomalies Patients with Asherman's syndrome Patients with uterine cavity distorted by myoma or endometrial polyps Patients with confirmed endometriosis or endometrioma Patients with BMI of <18.5 and >29.9
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timur Gurgan, MD,Professor
Phone
0905322317706
Email
tgurgan@gurganclinic.com.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Muberra Namlı Kalem, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziya Kalem, MD
Organizational Affiliation
Gurgan Clinic IVF and Women Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Halil Ruso, Embryologist
Organizational Affiliation
GurganClinic IVF and Women Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonis Makrigiannakis, MD,Professor
Organizational Affiliation
Greek University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gurgan Clinic IVF and Women Health Center
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06640
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziya Kalem, MD
Phone
0905326922383
Email
ziyakalem@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endometrial Injury In Recurrent Implantation Failure

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