MedDataX Logo

Effects of Probiotics and Electrophysiologic Therapy on Endometrium Repair

NCT ID: NCT03969472

Last Updated: 2019-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-05

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Endometrial Repair

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

probiotic Electrophysiologic Therapy uterine endometrial repair intrauterine adhesion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

probiotic group

apply probiotic after surgery

Group Type EXPERIMENTAL

probiotics

Intervention Type DRUG

apply probiotic after operation

Electrophysiologic therapy group

apply electrophysiologic therapy after surgery without probiotic

Group Type EXPERIMENTAL

Electrophysiologic Therapy

Intervention Type DEVICE

Pelvic floor electrophysiological therapy is used after surgery

control

without electrophysiologic therapy and probiotic after surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

probiotics

apply probiotic after operation

Intervention Type DRUG

Electrophysiologic Therapy

Pelvic floor electrophysiological therapy is used after surgery

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yuqing Chen

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yuqing Chen, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First affiliated hospital of SUN Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yuqing Chen, MD

Role: CONTACT

Phone: 13724067575

Email: [email protected]

Guoxia Yang, MD

Role: CONTACT

Phone: 15521396554

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yuqing Chen, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20190529

Identifier Type: -

Identifier Source: org_study_id