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Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

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ClinicalTrials.gov Identifier: NCT03731689
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University

Study Description
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Brief Summary:
This study aims to investigate the treatment of intrauterine adhesion and the factors influencing its prognosis.

Condition or disease Intervention/treatment Phase
Intrauterine Adhesions Drug: Intrauterine lavage therapy Drug: Intrauterine gel-injection therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Menstruation Pattern(Improvement or No Significant Change) of All Participants [ Time Frame: 1 year ]
    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.

  2. Reduction of American Fertility Society adhesion score at Second-look [ Time Frame: one year ]
    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.

  3. Number of Participants With Pregnancy after operation [ Time Frame: two years ]
  4. Differences in distribution of reproductive tract bacteria between patients are before and after operation [ Time Frame: one year ]
  5. Differences in distribution of reproductive tract bacteria between healthy control group and intrauterine adhesion patients [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731689


Contacts
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Contact: Yaling Guo, master 15622327162 1106561876@qq.com
Contact: Yuqing Chen, Deputy chief 13724067575 fangchenyq@163.com

Locations
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China, Guangzhou, Guangdong
Guangzhou Recruiting
Guangdong, Guangzhou, Guangdong, China, 510000
Contact: Yaling Guo, Master    15622327162    1106561876@qq.com   
Contact: Yuqing Chen, Chief    13724067575    fangchenyq@163.com   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Yuqing Chen, Deputy chief First Affiliated Hospital, Sun Yat-Sen University
More Information
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Responsible Party: Yuqing Chen, chief physician, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03731689    
Other Study ID Numbers: Intrauterine adhesions
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University:
intrauterine lavage therapy
hysteroscopy
microbiome
uterine endometrial repair
intrauterine gel-injection therapy
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes