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Effects of Probiotics and Electrophysiologic Therapy on Endometrium Repair

Effects of Probiotics and Pelvic Floor Muscle Electrophysiologic Therapy on Endometrium Repair in Patients With Intrauterine Adhesion.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03969472
Enrollment
120
Registered
2019-05-31
Start date
2019-05-05
Completion date
2020-12-31
Last updated
2019-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Endometrial Repair

Keywords

probiotic, Electrophysiologic Therapy, uterine endometrial repair, intrauterine adhesion

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.

Interventions

DRUGprobiotics

apply probiotic after operation

Pelvic floor electrophysiological therapy is used after surgery

Sponsors

First Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Endometrial ThicknessWithin the first 3 months after surgeryAll Participants in the Mid Menstrual Measured by Color Doppler Ultrasound

Secondary

MeasureTime frameDescription
Menstruation Pattern of All ParticipantsWithin the first 3 months after surgeryA method similar to VAS was employed for the evaluation of post-operative menstruation with 0 as amenorrhea and 100 as normal menstruation.
Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All ParticipantsWithin the first 3 months after surgeryThe severity and extent of intrauterine adhesions were scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version). A score of 1-4 was considered to represent mild adhesions, a score of 5-8 was considered to represent moderate adhesions and a score of 9-12 represented severe adhesions.

Countries

China

Contacts

Primary ContactYuqing Chen, MD
chyqing@mail.sysu.edu.cn13724067575
Backup ContactGuoxia Yang, MD
763225481@qq.com15521396554

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026