Confounding Factors of Chronic Endometritis in Women With Reproductive Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: IVF. Basic parameters: 20 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other
If the CE is high, antibiotics will be given to the patients as usual practice in hospitals.
Primary outcome measures
- Live birth rate [Time frame: 31 December 2027]
Secondary outcome measures (3)
- Compare the pregnancy rate between groups [Time frame: 31 March 2028]
- Compare the miscarriage rate between groups [Time frame: 31 March 2028]
- Compare the implantation rate between groups [Time frame: 31 March 2028]
Eligibility criteria
Inclusion criteria
- Age 20-45 years;
- Women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation12; or
- Women who failed to conceive after unprotected intercourse for one year; or
- Women who failed failure to achieve a clinical pregnancy after two consecutive cycles of IVF, ICSI or frozen embryo replacement cycles where the cumulative number of transferred embryos is no less than four for day-2 embryos and no less than 2 for day-5 embryos (blastocysts), with all embryos being of good quality.
Exclusion criteria
- Uncorrected uterine anomalies, such as the septate or bicornuate uterus, fibroids (submucous/intramural);
- Untreated hydrosalpinx;
- History of antiphospholipid syndrome;
- Known clinical autoimmune disease;
- Undergoing immunotherapy;
- Abnormal thyroid function;
- Abnormal karyotyping.
- Those with active pelvic inflammatory disease or suspicion of infection etc.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Hong Kong · 1 center
- The Chinese University of Hong Kong — Hong Kong
Identifiers
NCT: NCT05613049 · 2022.339