Assisted Reproductive TechnologyNCT03881072
Evaluating the Endometrial Receptivity of FET Patient by Ultrasounicelastography
A study testing Ultrasounicelastography in people with Assisted Reproductive Technology and Ultrasonography, run by Jinling Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Assisted Reproductive Technology, Ultrasonography
- What is being tested?
- Ultrasounicelastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- endometrial polyps, abnormal uterine cavity, intrauterine adhesions and dysplasia of uterus.
- hydrosalpinx was not ligated.
- patients with uterine myoma and uterine fibroids;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Assisted Reproductive Technology, Ultrasonography
- Being tested
- Ultrasounicelastography
- Keywords
- Ultrasounicelastography, Frozen embryo transplantation, Endometrial Receptivity, pregnancy outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasounicelastographyOther
Observing the correlation between endometrial elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasounicelastography | Other | Ultrasounicelastography:non-invasive, convenient and comprehensive evaluation method. Receives: Other: Ultrasounicelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial receptivity
Observing the correlation between elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Oct 2017
- Primary completion10 Jan 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing Yao, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881072
- Sponsor's protocol ID
- UE evaluating Em-receptivity
- Status last verified
- Mar 2019
- First submitted
- 12 Sep 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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 at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Endometrial Receptivity of FET Patients by Ultrasounicelastography and Predicting the Pregnancy Outcome.
- ClinicalTrials.gov ID
- NCT03881072
- Acronym / sponsor ID
- UE evaluating Em-receptivity
- Conditions
- Assisted Reproductive Technology, Ultrasonography
- Keywords
- Ultrasounicelastography, Frozen embryo transplantation, Endometrial Receptivity, pregnancy outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective study
| Arm | Type | Receives |
|---|---|---|
| Ultrasounicelastography | Other | Other: UltrasounicelastographyUltrasounicelastography:non-invasive, convenient and comprehensive evaluation method. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- endometrial polyps, abnormal uterine cavity, intrauterine adhesions and dysplasia of uterus.
- hydrosalpinx was not ligated.
- patients with uterine myoma and uterine fibroids;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasounicelastographyObserving the correlation between endometrial elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate. | Other | Ultrasounicelastography |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasounicelastography in people with Assisted Reproductive Technology and Ultrasonography, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometrial receptivity (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.