An observational study in IVF, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Chinese University of Hong Kong · Observational
The aim of the study is to investigate the confounding factors of chronic endometritis and therapeutic benefits of antibodies targeting plasma cells in women with reproductive failure.
Eligible women, based on the inclusion and exclusion criteria, will be recruited from the IVF and/ or miscarriage clinic in the Prince of Wales Hospital/ CUHK medical centre (CUMC). Endometrial sampling (ES) will alternatively be conducted during mid-luteal phase. In natural cycles, all the subjects will have a daily urine test from day 9 of the menstrual cycle to identify the Luteinizing Hormone (LH) surge. The ES will be obtained precisely 7 days after LH surge. In artificial cycles, 6mg estradiol will be given daily orally from day 2 of the menstrual cycle for 14+/-1-2 days. Transvaginal ultrasound will be performed on day 14 of the estrogen therapy to assess the endometrial thickness and to exclude ovarian activity. If endometrial thickness is ≥8 mm, plasma progesterone level is \< 4nmol/L, progesterone will be commenced using either Endometrin (Ferring, Saint-Prex, Switzerland) 100 mg TDS vaginally. ES will be obtained using a Pipelle sampler as an outpatient procedure. The ES will be obtained precisely 5 days after progesterone supplementation.
Immunohistochemical staining will be used to determine plasma cells by using a mouse antihuman monoclonal primary anti-CD138 antibody and anti-CD38 antibody. The total number of plasma cell present in the stroma of the entire specimen will be determined and expressed as plasma cell count per unit area of the specimen. If CE is present, antibiotics will be given following the guideline from the Hospital Authority (HA). Then ES will be taken again to be re-examined by histology and microbiology.
Subjects will be identified and recruited from the IVF and miscarriage clinic by clinicians and research nurse.
Exclusion criteria
Patients have 2 or more miscarriage or repeated implantation failure (RIF), or infertile women would be invited to do endometrial sampling (ES) procedure. The ES will be conducted randomly or when women undergo hysteroscopy or obtained precisely 7 days after LH surge. It will be obtained using a Pipelle sampler as an outpatient procedure.
Live birth rate
compare the brith rate between the group and cohort
Time frame: 31 December 2027
Compare the pregnancy rate between groups
compare the general pregnancy rate in women with or without CE
Time frame: 31 March 2028
Compare the miscarriage rate between groups
compare the miscarriage rate in women with or without CE
Time frame: 31 March 2028
Compare the implantation rate between groups
Compare the implantation successful rate in women with or without CE
Time frame: 31 March 2028
Plan to share: No
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Chinese University of Hong Kong