Clinical trial NCT03969472: Effects of Probiotics and Electrophysiologic Therapy on Endometrium Repair
Official title: Effects of Probiotics and Pelvic Floor Muscle Electrophysiologic Therapy on Endometrium Repair in Patients With Intrauterine Adhesion.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Endometrial Repair
Keywords: probiotic
Electrophysiologic Therapy
uterine endometrial repair
intrauterine adhesion
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effects of probiotics in combination with pelvic floor muscle electrophysiologic therapy on the uterine endometrial repair and reproductive prognosis in patients after surgery for intrauterine adhesion

Detailed description: Post-traumatic repair disorder of endometrium can cause intrauterine adhesions, amenorrhea and infertility, which seriously endanger women's reproductive health. In our previous study, high throughput sequencing of intrauterine microorganisms showed that the content of lactic acid bacteria in the uterine cavity of patients with intrauterine adhesions was significantly lower than that of normal people. Concurrently, our previous studies found that chronic endometritis can aggravate endometrial fibrosis, then affect the repair of endometrial trauma, and increase the recurrence of intrauterine adhesion. Our previous study also suggest that stem cells are beneficial to the repair of endometrium. Studies have shown that lactic acid can inhibit inflammatory response and regulate the proliferation of intestinal stem cells. So can lactic acid also change the microbial environment in uterine cavity to inhibit endometrial inflammation and regulate the proliferation of endometrial stem cells to help repair endometrial wounds? In addition, electrical stimulation can relieve depression and anxiety and play a sedative effect. In recent years, some studies have shown that pelvic floor electrophysiological therapy can improve the intimal blood flow resistance index of thin endometrium. Therefore, whether or not the pelvic floor electrophysiological therapy can repair the endometrium after the intrauterine adhesion. We expect probiotics and electrophysiologic therapy can promote endometrial repair after electrosurgical resection of intrauterine adhesions.

Eligibility criteria: Inclusion Criteria:

(1) Preoper- ative AFS score was ≥9; (2) the prior menstrual cycle was regular, and the sex hormone was normal; (3) patients had fertility requirement; (4) male semen examination appeared normal; (5) there were no severe systemic diseases and no contradictions to aspirin, estrogen, and surgery

Exclusion Criteria:

(1) Preoperative AFS score was \<9; (2) prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction, and infertility; (3) patients had no fertility requirement; (4) patients had male factor infertility; (5) patients had contradictions to estrogen and aspirin such as cancers (breast cancer and endometrial cancer), thrombotic diseases, allergy to antipyretic anal- gesics, severe liver injury, hypoprothrombinemia, vitamin K deficiency, hemophilia, thrombocytopenia, and gastric or duodenal ulcer and asthma

Primary outcomes:
measure: Endometrial Thickness
timeFrame: Within the first 3 months after surgery
Secondary outcomes:
measure: Menstruation Pattern of All Participants
timeFrame: Within the first 3 months after surgery
measure: Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants
timeFrame: Within the first 3 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First affiliated hospital of SUN Yat-Sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Yuqing Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: