Clinical Research Directory

Doxycycline and Progestin Therapy for Chronic Endometritis(CE) in Patients With Recurrent Reproductive Failure(RRF)

A Prospective Randomized Controlled Trial, the goal of this clinical trial is to evaluate the efficacy and safety of doxycycline alone versus doxycycline plus medroxyprogesterone acetate (MPA) in women with chronic endometritis (CE), and to assess subsequent reproductive outcomes. Participants will be randomly assigned to one of two groups and will receive the assigned treatment. Participants will be followed for reproductive outcomes, including pregnancy , ongoing pregnancy, spontaneous miscarriage, and live birth.

FuKe Qianjin Capsule Plus Antibiotics for Chronic Endometritis

This randomized, double-blind, single-dummy, multicenter clinical study, led by Principal Investigator Xue Fengxia at Tianjin Medical University General Hospital (sponsor and primary trial institution) and funded by Zhuzhou Qianjin Pharmaceutical Co., Ltd., evaluates the safety and efficacy of FuKe Qianjin Capsules combined with standard antibiotic therapy for chronic endometritis (CE) in women aged 20-40 years. CE, a common gynecological inflammation marked by uterine plasma cell infiltration from bacterial infection, is linked to infertility, repeated implantation failure (RIF), and recurrent miscarriage (RM); it is often underdiagnosed due to non-specific symptoms, and first-line doxycycline therapy is limited by antibiotic resistance and high recurrence. FuKe Qianjin Capsules, a nationally recognized Chinese herbal medicine for gynecological inflammations, align with traditional Chinese medicine (TCM) treatment principles for CE (damp-heat stasis with qi and blood deficiency) and reduce antibiotic resistance per domestic research. Approximately 300 eligible participants (confirmed CE via hysteroscopy/pathology, matching TCM syndrome, regular menstrual cycles, informed consent) will be enrolled across 10-15 Chinese centers, with exclusion for acute infections, gynecological malignancies/ severe uterine lesions, organ dysfunction, uncontrolled systemic diseases, pregnancy/lactation, drug hypersensitivity, or recent trial participation. All receive 14 days of oral doxycycline (100mg twice daily) and are randomized 1:1 to two double-blind groups (150 each): Experimental Group (56 days of FuKe Qianjin Capsules, 0.4g/capsule, 2 capsules three times daily) or Control Group (56 days of matched capsule placebo). The study includes a 28-day screening period, 56-day treatment phase, and 6-month post-treatment follow-up (in-person visits at Day 28±5/56±7; telephone/outpatient follow-up at 3/6 months). Efficacy assessments (hysteroscopy, TCM scoring, ultrasound), safety monitoring (vital signs, blood work, pregnancy testing), adverse event recording, and medication adherence checks occur at all visits, with ultrasound-confirmed clinical pregnancy rate as the key post-treatment outcome. The team monitors known drug adverse effects (mild gastrointestinal/skin/neurological symptoms for the capsules; gastrointestinal/photosensitivity/rare liver/blood issues for doxycycline) and hysteroscopy risks (mild bleeding, rare perforation), with emergency protocols in place. Participants may withdraw voluntarily at any time with no impact on regular care; all data/specimens are confidential, de-identified, and used only for study research (no commercial use). Overseen by the hospital's Institutional Ethics Committee and compliant with national research standards, the study's primary goal is to confirm the combined regimen's superior safety and efficacy over antibiotic monotherapy for CE, as well as its ability to improve reproductive outcomes and reduce recurrence. A positive result will establish this integrated Chinese-Western medicine approach as an evidence-based CE treatment, reducing antibiotic resistance and enhancing reproductive health for affected women, especially those with infertility, RIF, or recurrent miscarriage.

Randomized Controlled Trial of Berberine in Combination With Doxycycline in the Treatment of Chronic Endometritis

Study Subjects: Eligible patients were initially diagnosed with chronic endometritis (CE) by CD138 testing through outpatient hysteroscopy. Positive CD138 expression is defined as at least one or more positive-staining plasma cells per 10 high-power fields identified as positive, and less than one positive-stained plasma cell identified as negative \[8\]. All patients signed an informed consent form prior to participating in the study, and the study followed the principles of the Declaration of Helsinki. Inclusion Criteria: Diagnosis of chronic endometritis by CD138 immunohistochemistry; Age≥ 20 years old, females of childbearing age; Agree to undergo hysteroscopy and hysteroscopic endometrial biopsy; No serious systemic disease; There are no contraindications to oral administration of doxycycline hydrochloride and berberine hydrochloride. Exclusion criteria: patients with pregnancy status, uterine malignant disease, hormone therapy within 3 months, glucose-6 phosphate dehydrogenase deficiency, hemolytic anemia, hypersensitivity to berberine hydrochloride or doxycycline. In addition, berberine hydrochloride has fewer oral adverse reactions, occasional nausea and vomiting, rash and drug fever, which disappear after stopping the drug. If the patient takes the wrong or missed medication, it is excluded. Withdrawal criteria: If the patient has corresponding adverse reaction symptoms, those with mild symptoms can be temporarily observed, and if the symptoms are severe, they can be transferred to the Department of Gastroenterology for diagnosis and treatment, and those who need to stop the drug will be withdrawn from this study.