Confounding Factors of Chronic Endometritis in Women With Reproductive Failure

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05613049

Collaborator

(none)

720

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
IVF

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

720 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Confounding Factors of Chronic Endometritis in Women With Reproductive Failure

Anticipated Study Start Date :

Jan 30, 2023

Anticipated Primary Completion Date :

Jul 31, 2027

Anticipated Study Completion Date :

Jan 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Observational group 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.

Outcome Measures

Primary Outcome Measures

Live birth rate [31 December 2027]
compare the brith rate between the group and cohort

Secondary Outcome Measures

Compare the pregnancy rate between groups [31 March 2028]
compare the general pregnancy rate in women with or without CE
Compare the miscarriage rate between groups [31 March 2028]
compare the miscarriage rate in women with or without CE
Compare the implantation rate between groups [31 March 2028]
Compare the implantation successful rate in women with or without CE

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.