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Transcriptome Profiling and Endometrial Receptivity

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ClinicalTrials.gov Identifier: NCT03925311
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Chung Pui Wah Jacqueline, Chinese University of Hong Kong

Study Description
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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.

Condition or disease Intervention/treatment
Pregnancy Related 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) to compare different kinds of biochemical markers.
Study Design
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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Transcriptome Profiling and Immune/ Biochemical Markers of Peripheral Blood to Predict Endometrial Receptivity and Successful Implantation
Actual Study Start Date : April 20, 2015
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Intervention Details:
  • Procedure: endometrial biopsy and blood sampling
    patient will be performed endometrial biopsy and collected blood samples at particular time points

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples With DNA
blood samples

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study only focuses on female group
Sampling Method:   Probability Sample
Study Population
Subjects will be recruited from the Prince of Wales Hospital.
Criteria

Inclusion Criteria:

Age 20-40 years.

Exclusion Criteria:

  • Uncorrected uterine anomalies, such as septate or bicornuate uterus, fibroids (submucous/intramural).
  • Intrauterine adhesions.
  • Adenomyosis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925311


Contacts
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Contact: Hiu Tan Margaret Lee 85235051764 margaretlee@cuhk.edu.hk
Contact: Pui Wah Jacqueline Chung, MBBS 85235051764 jacquelinechung@cuhk.edu.hk

Locations
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Hong Kong
Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Hiu Tan Margaret Lee    (852)35051764    margaretlee@cuhk.edu.hk   
Contact: Pui Wah Jacqueline Chung, MBBS    (852)35051764    jacquelinechung@cuhk.edu.hk   
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         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Pui Wah Jacqueline Chung, MBBS Chinese University of Hong Kong
More Information
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Responsible Party: Chung Pui Wah Jacqueline, Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03925311    
Other Study ID Numbers: 2014.637
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chung Pui Wah Jacqueline, Chinese University of Hong Kong:
Transcriptome
endometrial receptivity