NCT03925311

Brief Summary

The aim of this study is to correlate and identify the biochemical markers which may reflect WOI. Blood samples will be collected and endometrial biopsy will be performed at particular time points.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 20, 2015

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

10.7 years

First QC Date

April 3, 2019

Last Update Submit

March 26, 2025

Conditions

Keywords

Transcriptomeendometrial receptivity

Outcome Measures

Primary Outcomes (2)

  • The change of the transcriptome profiling in the peripheral blood

    RNA per sample will be prepared into two portions. One is for RNA sequencing and the other is for small RNA sequencing. The next step is hydrolysis of RNA into 200-300 nucleotides prior to reverse transcription. When sequencing RNA other than mRNA the library preparation is modified. The cellular RNA is selected based on the desired size range. For miRNA, the RNA is isolated through size selection. Once isolated, linkers are added to the 3' and 5' end then purified. The final step is cDNA generation through reverse transcription.

    From the day of endometrial biopsy through study completion, an average of 2 months

  • The change of the immune markers in the peripheral blood

    Immune markers including cytokines such as leukemia inhibitory factor, macrophage colony stimulating factor, interleukin - 1 beta, transforming growth factor beta-1, Tim-3, galectin-9 and other markers considered to play a role in implantation will also be measured.

    From the day of endometrial biopsy through study completion, an average of 2 months

Interventions

patient will be performed endometrial biopsy and collected blood samples at particular time points

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study only focuses on female group
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Subjects will be recruited from the Prince of Wales Hospital.

You may qualify if:

  • Age 20-40 years.

You may not qualify if:

  • Uncorrected uterine anomalies, such as septate or bicornuate uterus, fibroids (submucous/intramural).
  • Intrauterine adhesions.
  • Adenomyosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pui Wah Jacqueline Chung, MBBS

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hiu Tan Margaret Lee

CONTACT

Pui Wah Jacqueline Chung, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 24, 2019

Study Start

April 20, 2015

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations