Effects of Probiotics and Electrophysiologic Therapy on Endometrium Repair

NCT03969472 | Unknown DMC

• 1 other identifier: 20190529
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Uterine Endometrial Repair

Keywords

probiotic; Electrophysiologic Therapy; uterine endometrial repair; intrauterine adhesion

Outcome Measures

Primary Outcomes (1)

• Endometrial Thickness

  All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound

  Within the first 3 months after surgery

Secondary Outcomes (2)

• Menstruation Pattern of All Participants

  Within the first 3 months after surgery

• Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants

  Within the first 3 months after surgery

Study Arms (3)

probiotic group

EXPERIMENTAL

apply probiotic after surgery

Drug: probiotics

Electrophysiologic therapy group

EXPERIMENTAL

apply electrophysiologic therapy after surgery without probiotic

Device: Electrophysiologic Therapy

control

NO INTERVENTION

without electrophysiologic therapy and probiotic after surgery

Interventions

probiotics DRUG

apply probiotic after operation

probiotic group

Electrophysiologic Therapy DEVICE

Pelvic floor electrophysiological therapy is used after surgery

Electrophysiologic therapy group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

First affiliated hospital of SUN Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Gynatresia

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Yuqing Chen, MD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuqing Chen, MD

CONTACT

13724067575; chyqing@mail.sysu.edu.cn

Guoxia Yang, MD

CONTACT

15521396554; 763225481@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: May 5, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 31, 2019

Record last verified: 2019-05

Locations

CN (1)