The Effect of Endometrial Scratching on Patients With End... | NCT05360875

Studies
The Effect of Endometrial Scratching on Patients With Endometriosis

NCT05360875

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

May 4, 2022Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Endometriosis
IVF

Interventions

Endometrial scratching

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Apr 30, 2023Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

May 1, 2022

First Submission Date that Met QC Criteria

May 1, 2022

First Posted Date

May 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2022

Last Update Posted Date

May 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Qi Yu, professor, Peking Union Medical College HospitalPrincipal Investigator

Lead Sponsor

Peking Union Medical College HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We aimed to investigate whether endometrial scratching could improve IVF outcomes by enhancing endometrial receptivity in patients with endometriosis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endometrial scratching group	Experimental		Procedure: Endometrial scratching
Non-scratching group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endometrial scratching	Procedure	An intrauterine procedure that causes mild endometrial injury	Endometrial scratching group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate	pregnancy sacs confirmed by ultrasound	6-7 weeks of gestation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality	100730	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided