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The 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
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Endometrial scratching, Endometrial receptivity, IVF, Pregnancy rates

Eligibility Criteria

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

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

First Posted
May 1, 2022
Last Updated
May 1, 2022
Sponsor
Peking Union Medical College Hospital
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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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