Pregnancy RelatedNCT03925311
Transcriptome Profiling and Endometrial Receptivity
An observational study of Pregnancy Related, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- endometrial biopsy and blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Apr 2015to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult
Study population: Subjects will be recruited from the Prince of Wales Hospital.
Who may be able to join
- Age 20-40 years.
Who cannot join
- Uncorrected uterine anomalies, such as septate or bicornuate uterus, fibroids (submucous/intramural).
- Intrauterine adhesions.
- Adenomyosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong
Hiu Tan Margaret Lee, (852)35051764, margaretlee@cuhk.edu.hk
Pui Wah Jacqueline Chung, MBBS, (852)35051764, jacquelinechung@cuhk.edu.hk
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- endometrial biopsy and blood sampling
- Keywords
- Transcriptome, endometrial receptivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial biopsy and blood samplingProcedure or surgery
patient will be performed endometrial biopsy and collected blood samples at particular time points
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the day of endometrial biopsy through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start20 Apr 2015
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Pui Wah Jacqueline, Chinese University of Hong Kong
- Investigators
- Pui Wah Jacqueline Chung, MBBS, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925311
- Sponsor's protocol ID
- 2014.637
- Status last verified
- Mar 2025
- First submitted
- 3 Apr 2019
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptome Profiling and Immune/ Biochemical Markers of Peripheral Blood to Predict Endometrial Receptivity and Successful Implantation
- ClinicalTrials.gov ID
- NCT03925311
- Acronym / sponsor ID
- 2014.637
- Conditions
- Pregnancy Related
- Keywords
- Transcriptome, endometrial receptivity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Apr 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Subjects will be recruited from the Prince of Wales Hospital.
Key inclusion criteria (1 listed)
- Age 20-40 years.
Key exclusion criteria (3 listed)
- Uncorrected uterine anomalies, such as septate or bicornuate uterus, fibroids (submucous/intramural).
- Intrauterine adhesions.
- Adenomyosis.
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 |
|---|---|---|
| endometrial biopsy and blood samplingpatient will be performed endometrial biopsy and collected blood samples at particular time points | Procedure or surgery | – |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Pui Wah Jacqueline Chung, MBBS principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 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: looking for participants now, as of the sponsor's last update on 27 Mar 2025. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hiu Tan Margaret Lee (85235051764, margaretlee@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. 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 27 Mar 2025.