NCT05360875

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

May 1, 2022

Last Update Submit

May 1, 2022

Conditions

EndometriosisIVF

Keywords

EndometriosisEndometrial scratchingEndometrial receptivityIVFPregnancy rates

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    pregnancy sacs confirmed by ultrasound

    6-7 weeks of gestation

Study Arms (2)

Endometrial scratching group

EXPERIMENTAL
Procedure: Endometrial scratching

Non-scratching group

NO INTERVENTION

Interventions

Endometrial scratchingPROCEDURE

An intrauterine procedure that causes mild endometrial injury

Endometrial scratching group

Eligibility Criteria

Age22 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Endometriosis that surgery or pathology confirmed; 2. normal ovarian reserve; 3. at least one implantation failure history

You may not qualify if:

  • \. hydrosalpinx; 2.ademomyosis; 3.endocrine or self-immune disease; 4.serious medical condition; 5.Contraindications of intrauterine operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 1, 2022

First Posted

May 4, 2022

Study Start

May 1, 2022

Primary Completion

April 30, 2023

Study Completion

June 30, 2023

Last Updated

May 4, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

CN(1)