Transcriptome Profiling and Endometrial Receptivity

Recruiting

• Conditions: Pregnancy Related

• Registration Number: NCT03925311
• Lead Sponsor: Chinese University of Hong Kong

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.

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 Timeline

• Study Start: 2015-04-20
• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

Age 20-40 years.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of the immune markers in the peripheral blood	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.
The change of the transcriptome profiling in the peripheral blood	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.

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong