Confounding Factors of Chronic Endometritis in Women With Reproductive Failure

ConditionIVF
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-45
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Uncorrected uterine anomalies, such as the septate or bicornuate uterus, fibroids (submucous/intramural);

Untreated hydrosalpinx;

History of antiphospholipid syndrome;

Known clinical autoimmune disease;

Trial population

Subjects will be identified and recruited from the IVF and miscarriage clinic by clinicians and research nurse.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Other intervention

    If the CE is high, antibiotics will be given to the patients as usual practice in hospitals.

Treatment groups

720 Participants
are divided into 1 treatment group
Group A: Observational group0 interventions

Trial outcomes

Primary outcomes

1

Live birth rate

compare the brith rate between the group and cohort

Time frame
31 December 2027

Secondary outcomes

1

Compare the pregnancy rate between groups

compare the general pregnancy rate in women with or without CE

Time frame
31 March 2028
2

Compare the miscarriage rate between groups

compare the miscarriage rate in women with or without CE

Time frame
31 March 2028
3

Compare the implantation rate between groups

Compare the implantation successful rate in women with or without CE

Time frame
31 March 2028

Other outcomes

Sponsors and contacts

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