Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

This study aims to investigate the treatment of intrauterine adhesion and the factors influencing its prognosis.

Study Overview

• Status: Unknown
• Conditions: Intrauterine Adhesions
• Intervention / Treatment: Drug: Intrauterine lavage therapy; Drug: Intrauterine gel-injection therapy

Detailed Description

Intrauterine adhesion, also known as Asherman's syndrome, is the partial or complete occlusion of the uterine cavity as a result of endometrium damage. Most intrauterine adhesions patients manifest amenorrhea, reduced menstrual pattern, infertility, and intrauterine growth restriction, which seriously affect their reproductive health.It is well established that the formation of intrauterine adhesion likely involves hypoxia, reduced neovascularization, and altered expression of adhesion associated cytokines, but the exact mechanisms are not well understood. Although excessive curettage is considered the primary cause, intrauterine adhesion is known to be associated with diverse non-traumatic factors, such as postabortal sepsis, puerperal sepsis and infections. Intrauterine adhesion separation surgery is the gold standard for the treatment of uterine adhesion. Although the success rate is as high as 95%, the patients with moderate or severe uterine adhesion have severe damage to the endometrial basement, poor regeneration of endometrial and gland, poor tolerance of endometrial and poor clinical prognosis. Even if all kinds of anti-adhesion measures are used comprehensively, the postoperative recurrence rate of patients with moderate and severe uterine adhesion is high.Therefore this study was conducted to investigate whether intrauterine lavage or intrauterine gel-injection therapy after surgery could reduce the recurrence of intrauterine adhesion, promote the endometrial growth and repair and improve the menstruation and reproductive prognosis for severe intrauterine adhesion, and we hypothesize that intrauterine adhesion may be related to changes in microbial flora in the reproductive tract.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yaling Guo, Master; Phone Number: 15622327162; Email: 1106561876@qq.com
• Study Contact Backup: Name: Yuqing Chen, Deputy chief; Phone Number: 13724067575; Email: fangchenyq@163.com

Study Locations

• China
  • Guangzhou, Guangdong
    • Guangdong, Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Guangzhou
      • Contact: Yaling Guo, Master; Phone Number: 15622327162; Email: 1106561876@qq.com
      • Contact: Yuqing Chen, Chief; Phone Number: 13724067575; Email: fangchenyq@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Inclusion Criteria(experimental group and control group):

• Pre-operative adhesion score was ≥5
• The prior menstrual cycle was regular, and the sex hormone was normal
• Patients had fertility requirement
• Male semen examination showed normal
• There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery

Inclusion Criteria(healthy control group):

• regular menstrual cycles,diagnostic hysteroscopy with endometrial biopsy and laparoscopy as part of their infertility diagnostic work-up prior to IVF, hysteroscopy and subsequent pathological results having shown no abnormality in the uterine cavities and abdominal cavity
• the healthy women recruited had male partners who were infertile and diagnosed with defective sperm function,such as asthenozoospermia, oligoasthenozoospermia, severe oligoasthenozoospermia and azoospermia, defined according to guidelines published by the World Health Organization.

Exclusion Criteria:

• Pre-operative adhesion score was <5
• Prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction and infertility
• Patients had no fertility requirement
• Patients(experimental group and control group) had male factor infertility
• Patients had contradictions to estrogen and aspirin such as cancers (breast cancer and endometrial cancer), thrombotic diseases, allergy to antipyretic analgesics, severe liver injury, hypoprothrombinemia, vitamin K deficiency, hemophilia, thrombocytopenia, gastric or duodenal ulcer and asthma.
• refuse Endometrial biopsy
• Vaginal discharge abnormal, or suspected vaginitis or pelvic inflammatory disease, or using antibiotics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Control group( Intrauterine patients) do not apply intrauterine lavage therapy or intrauterine gel-injection therapy after surgery.
Experimental: Intrauterine lavage therapy group; Intrauterine lavage therapy group apply intrauterine lavage therapy after surgery.	Drug: Intrauterine lavage therapy; Intrauterine lavage treatment was performed within 3 to 7 days after the first menstrual period after surgery.
Experimental: Intrauterine gel-injection therapy group; Intrauterine gel-injection therapy group apply intrauterine gel-injection therapy after surgery.	Drug: Intrauterine gel-injection therapy; Intrauterine gel-injection treatment was performed within 3 to 7 days after the first menstrual period after surgery.
No Intervention: Healthy control group; Healthy control group 1)have regular menstrual cycles,diagnostic hysteroscopy with endometrial biopsy and laparoscopy as part of their infertility diagnostic work-up prior to IVF, hysteroscopy and subsequent pathological results having shown no abnormality in the uterine cavities and abdominal cavity.2) had male partners who were infertile and diagnosed with defective sperm function,such as asthenozoospermia, oligoasthenozoospermia, severe oligoasthenozoospermia and azoospermia, defined according to guidelines published by the World Health Organization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstruation Pattern(Improvement or No Significant Change) of All Participants	A method similar to visual analogue scale(VAS) was employed for the evaluation of post-operative menstruation with 0 as amenorrhea and 100 as normal menstruation.	1 year
Reduction of American Fertility Society adhesion score at Second-look	The severity and extent of intrauterine adhesions were scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version) [7]. 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.	one year
Number of Participants With Pregnancy after operation		two years
Differences in distribution of reproductive tract bacteria between patients are before and after operation		one year
Differences in distribution of reproductive tract bacteria between healthy control group and intrauterine adhesion patients		one year

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Yuqing Chen, Deputy chief, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: November 3, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 3, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: hysteroscopy; microbiome; uterine endometrial repair; intrauterine lavage therapy; intrauterine gel-injection therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: Intrauterine adhesions

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No