- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925311
Transcriptome Profiling and Endometrial Receptivity
Transcriptome Profiling and Immune/ Biochemical Markers of Peripheral Blood to Predict Endometrial Receptivity and Successful Implantation
Study Overview
Status
Conditions
Intervention / Treatment
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:
- performed endometrial biopsy
- taken blood for a few time points (e.g. pre-conception and being pregnant) and to compare different kinds of biochemical markers.
Study Type
Enrollment (Estimated)
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
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Hong Kong, Hong Kong
- Recruiting
- Chinese University of Hong Kong
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Sub-Investigator:
- Chi Chiu Wang, MBBS, PhD
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Sub-Investigator:
- Jin Huang, MBBS, PhD
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Sub-Investigator:
- Xiaoyan Chen, MBBS, MPhil, PhD
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Sub-Investigator:
- Tin Chiu Li, MBBS, PhD
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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
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The change of the transcriptome profiling in the peripheral blood
Time Frame: From the day of endometrial biopsy through study completion, an average of 2 months
|
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
Time Frame: From the day of endometrial biopsy through study completion, an average of 2 months
|
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
Investigators
- Principal Investigator: Pui Wah Jacqueline Chung, MBBS, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2014.637
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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