Evaluating the Endometrial Receptivity of FET Patient by Ultrasounicelastography

Sponsor

Jinling Hospital, China (Other)

Overall Status

Completed

CT.gov ID

NCT03881072

Collaborator

(none)

100

Enrollment

Location

Arm

14.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Assisted Reproductive Technology Ultrasonography	Other: Ultrasounicelastography	N/A

Detailed Description

Randomly selecting 20-40 years patients were prepared to accept frozen embryo transplant ; HRT cycle preparation of endometrium；choosing HRT plan to prepare the transplantation endometrium.Establishing a strict standard of exclusion and exclude standard to exclude endometrial lesions and underlying disease.The patients were given elastography for 5-7 days afterEndometrium transformation.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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective studyProspective study

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Evaluating the Endometrial Receptivity of FET Patients by Ultrasounicelastography and Predicting the Pregnancy Outcome.

Actual Study Start Date :

Oct 1, 2017

Actual Primary Completion Date :

Jan 10, 2018

Actual Study Completion Date :

Dec 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Ultrasounicelastography Ultrasounicelastography:non-invasive, convenient and comprehensive evaluation method.	Other: Ultrasounicelastography Observing the correlation between endometrial elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate.

Arm

Intervention/Treatment

Other: Ultrasounicelastography

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

Other: Ultrasounicelastography

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

Outcome Measures

Primary Outcome Measures

endometrial receptivity [Month 12]
Observing the correlation between elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yao Bing	Nanjing	Jiang Su	China	2100000

Sponsors and Collaborators

Jinling Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bing Yao, Professor，Chief physician, Jinling Hospital, China

ClinicalTrials.gov Identifier:

NCT03881072

Other Study ID Numbers:

UE evaluating Em-receptivity

First Posted:

Mar 19, 2019

Last Update Posted:

Mar 19, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bing Yao, Professor，Chief physician, Jinling Hospital, China

Ultrasounicelastography

Frozen embryo transplantation

Endometrial Receptivity

pregnancy outcome

Study Results

No Results Posted as of Mar 19, 2019