Evaluating the Endometrial Receptivity of FET Patient by Ultrasounicelastography

March 18, 2019 updated by: Bing Yao, Jinling Hospital, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiang Su
      • Nanjing, Jiang Su, China, 2100000
        • Yao Bing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endometrial receptivity
Time Frame: Month 12
Observing the correlation between elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate.
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

January 10, 2018

Study Completion (ACTUAL)

December 10, 2018

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

March 18, 2019

First Posted (ACTUAL)

March 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UE evaluating Em-receptivity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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