Back to resultsThe Effect of Endometrial Scratching on Patients With Endometriosis
Primary Purpose
Endometriosis, IVF
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endometrial scratching
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Endometrial scratching, Endometrial receptivity, IVF, Pregnancy rates
Eligibility Criteria
Inclusion Criteria:
1.Endometriosis that surgery or pathology confirmed; 2. normal ovarian reserve; 3. at least one implantation failure history
Exclusion Criteria:
1. hydrosalpinx; 2.ademomyosis; 3.endocrine or self-immune disease; 4.serious medical condition; 5.Contraindications of intrauterine operation
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Endometrial scratching group
Non-scratching group
Arm Description
Outcomes
Primary Outcome Measures
clinical pregnancy rate
pregnancy sacs confirmed by ultrasound
Secondary Outcome Measures
Full Information
NCT ID
NCT05360875
First Posted
May 1, 2022
Last Updated
May 1, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05360875
Brief Title
The Effect of Endometrial Scratching on Patients With Endometriosis
Official Title
The Effect of Endometrial Scratching on Patients With Endometriosis Undergoing IVF Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
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
We aimed to investigate whether endometrial scratching could improve IVF outcomes by enhancing endometrial receptivity in patients with endometriosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, IVF
Keywords
Endometriosis, Endometrial scratching, Endometrial receptivity, IVF, Pregnancy rates
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endometrial scratching group
Arm Type
Experimental
Arm Title
Non-scratching group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Endometrial scratching
Intervention Description
An intrauterine procedure that causes mild endometrial injury
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Description
pregnancy sacs confirmed by ultrasound
Time Frame
6-7 weeks of gestation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Endometriosis that surgery or pathology confirmed; 2. normal ovarian reserve; 3. at least one implantation failure history
Exclusion Criteria:
1. hydrosalpinx; 2.ademomyosis; 3.endocrine or self-immune disease; 4.serious medical condition; 5.Contraindications of intrauterine operation
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Yu, professor
Phone
13701227034
Email
yuqi2008001@sina.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effect of Endometrial Scratching on Patients With Endometriosis
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