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Confounding Factors of Chronic Endometritis in Women With Reproductive Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05613049
Recruitment Status : Recruiting
First Posted : November 14, 2022
Last Update Posted : February 22, 2023
Sponsor:
Information provided by (Responsible Party):
Chung Pui Wah Jacqueline, Chinese University of Hong Kong

Study Description
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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
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
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Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Confounding Factors of Chronic Endometritis in Women With Reproductive Failure
Actual Study Start Date : January 26, 2023
Estimated Primary Completion Date : July 31, 2027
Estimated Study Completion Date : January 31, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Live birth rate [ Time Frame: 31 December 2027 ]
    compare the brith rate between the group and cohort


Secondary Outcome Measures :
  1. Compare the pregnancy rate between groups [ Time Frame: 31 March 2028 ]
    compare the general pregnancy rate in women with or without CE

  2. Compare the miscarriage rate between groups [ Time Frame: 31 March 2028 ]
    compare the miscarriage rate in women with or without CE

  3. Compare the implantation rate between groups [ Time Frame: 31 March 2028 ]
    Compare the implantation successful rate in women with or without CE


Biospecimen Retention:   None Retained
Patient will be invited to do endometrial sampling

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Please kindly see the inclusion criteria. The endometrics sampling is only done for female patients.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be identified and recruited from the IVF and miscarriage clinic by clinicians and research nurse.
Criteria

Inclusion criteria:

  1. Age 20-45 years;
  2. Women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation12; or
  3. Women who failed to conceive after unprotected intercourse for one year; or
  4. 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

  1. Uncorrected uterine anomalies, such as the septate or bicornuate uterus, fibroids (submucous/intramural);
  2. Untreated hydrosalpinx;
  3. History of antiphospholipid syndrome;
  4. Known clinical autoimmune disease;
  5. Undergoing immunotherapy;
  6. Abnormal thyroid function;
  7. Abnormal karyotyping.
  8. Those with active pelvic inflammatory disease or suspicion of infection etc.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05613049


Contacts
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Contact: Stacey Wong, BSc 35051764 staceywong@cuhk.edu.hk
Contact: JacquelinePui Wah Chung, MBBS 35051764 jacquelinechung@cuhk.edu.hk

Locations
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Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: PUI WAH JACQUELINE CHUNG, MBBS    +852 35051537    jacquelinechung@cuhk.edu.hk   
Contact: Stacey Wong, Bsc    +852 35051764    staceywong@cuhk.edu.hk   
Principal Investigator: PUI WAH JACQUELINE CHUNG, MBBS         
Sub-Investigator: NGA PING PATRICIA IP, MBBS         
Sub-Investigator: KAREN NG, MBBS         
Sub-Investigator: CHI CHIU RONALD WANG, MBBS         
Sub-Investigator: TAO ZHANG, MBBS         
Sub-Investigator: JING XI JOSHUA LI, MBBS         
Sub-Investigator: LAI PING CHEUNG, MBBS         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Jacqueline Pui Wah Chung, MBBS Chinese University of Hong Kong
More Information
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Responsible Party: Chung Pui Wah Jacqueline, Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT05613049    
Other Study ID Numbers: 2022.339
First Posted: November 14, 2022    Key Record Dates
Last Update Posted: February 22, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Chung Pui Wah Jacqueline, Chinese University of Hong Kong:
chronic endometritis
confounding factors
reproductive failure
 infertility
IVF
infertility women
Additional relevant MeSH terms:
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Endometritis
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Uterine Diseases
Genital Diseases