Transcriptome Profiling and Endometrial Receptivity

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03925311
• Other study ID #: 2014.637
• Status: Recruiting
• Start date: April 20, 2015
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: Hiu Tan Margaret Lee
• Phone: 85235051764
• Email: margaretlee[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

Age 20-40 years.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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