NCT03881072

Brief Summary

Prospective clinical study ：observing the correlation between endometrial elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate. In order to find a non-invasive, convenient and comprehensive evaluation method of evaluating the endometrial receptivity, and to provide effective means for the frozen embryo transplantation patients to improving pregnancy outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

September 12, 2018

Last Update Submit

March 18, 2019

Conditions

Assisted Reproductive TechnologyUltrasonography

Keywords

UltrasounicelastographyFrozen embryo transplantationEndometrial Receptivitypregnancy outcome

Outcome Measures

Primary Outcomes (1)

  • endometrial receptivity

    Observing the correlation between elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate.

    Month 12

Study Arms (1)

Ultrasounicelastography

OTHER

Ultrasounicelastography:non-invasive, convenient and comprehensive evaluation method.

Other: Ultrasounicelastography

Interventions

UltrasounicelastographyOTHER

Observing the correlation between endometrial elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate.

Ultrasounicelastography

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • the volunteers voluntarily signed the informed consent.
  • female patients between 20-40 years old.
  • HRT cycle.
  • no uterine cavity operation was performed within 3 months.

You may not qualify if:

  • endometrial polyps, abnormal uterine cavity, intrauterine adhesions and dysplasia of uterus.
  • hydrosalpinx was not ligated.
  • patients with uterine myoma and uterine fibroids;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yao Bing

Nanjing, Jiangsu, 2100000, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Prospective study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor，Chief physician

Study Record Dates

First Submitted

September 12, 2018

First Posted

March 19, 2019

Study Start

October 1, 2017

Primary Completion

January 10, 2018

Study Completion

December 10, 2018

Last Updated

March 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

In order to find a non-invasive, convenient and comprehensive evaluation method of evaluating the endometrial receptivity, and to provide effective means for the frozen embryo transplantation patients to improving pregnancy outcome.

Locations

CN(1)