Transcriptome Profiling and Endometrial Receptivity

Transcriptome Profiling and Immune/ Biochemical Markers of Peripheral Blood to Predict Endometrial Receptivity and Successful Implantation

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Procedure: endometrial biopsy and blood sampling

Detailed Description

Endometrial receptivity in the midluteal phase of the menstrual cycle, known as the window of implantation (WOI), occurs only for a very short period of time. However, so far, there is no reliable clinical and biochemical indicators of WOI. Therefore, this study is to correlate and identify the biochemical markers which may reflect WOI.

participants will be asked to be:

1. performed endometrial biopsy
2. taken blood for a few time points (e.g. pre-conception and being pregnant) and to compare different kinds of biochemical markers.

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Hiu Tan Margaret Lee; Phone Number: 85235051764; Email: margaretlee@cuhk.edu.hk
• Study Contact Backup: Name: Pui Wah Jacqueline Chung, MBBS; Phone Number: 85235051764; Email: jacquelinechung@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Chinese University of Hong Kong
    • Sub-Investigator: Chi Chiu Wang, MBBS, PhD
    • Sub-Investigator: Jin Huang, MBBS, PhD
    • Sub-Investigator: Xiaoyan Chen, MBBS, MPhil, PhD
    • Sub-Investigator: Tin Chiu Li, MBBS, PhD
    • Contact: Hiu Tan Margaret Lee; Phone Number: (852)35051764; Email: margaretlee@cuhk.edu.hk
    • Contact: Pui Wah Jacqueline Chung, MBBS; Phone Number: (852)35051764; Email: jacquelinechung@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from the Prince of Wales Hospital.

Description

Inclusion Criteria:

Age 20-40 years.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Pui Wah Jacqueline Chung, MBBS, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2015
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: endometrial receptivity; Transcriptome
• Other Study ID Numbers: 2014.637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No