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Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

Primary Purpose

Intrauterine Adhesions

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Intrauterine lavage therapy

Intrauterine gel-injection therapy

About this trial

This is an interventional treatment trial for Intrauterine Adhesions focused on measuring intrauterine lavage therapy, hysteroscopy, microbiome, uterine endometrial repair, intrauterine gel-injection therapy

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

GuangzhouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Control group

Intrauterine lavage therapy group

Intrauterine gel-injection therapy group

Healthy control group

Arm Description

Control group( Intrauterine patients) do not apply intrauterine lavage therapy or intrauterine gel-injection therapy after surgery.

Intrauterine lavage therapy group apply intrauterine lavage therapy after surgery.

Intrauterine gel-injection therapy group apply intrauterine gel-injection therapy after surgery.

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.

Outcomes

Primary Outcome Measures

Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound

Secondary Outcome Measures

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.

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.

Number of Participants With Pregnancy after operation

Differences in distribution of reproductive tract bacteria between patients are before and after operation

Differences in distribution of reproductive tract bacteria between healthy control group and intrauterine adhesion patients

Full Information

NCT ID

NCT03731689

First Posted

November 3, 2018

Last Updated

November 3, 2018

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT03731689

Brief Title

Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

Official Title

Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intrauterine Adhesions

Keywords

intrauterine lavage therapy, hysteroscopy, microbiome, uterine endometrial repair, intrauterine gel-injection therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Control group( Intrauterine patients) do not apply intrauterine lavage therapy or intrauterine gel-injection therapy after surgery.

Arm Title

Intrauterine lavage therapy group

Arm Type

Experimental

Arm Description

Intrauterine lavage therapy group apply intrauterine lavage therapy after surgery.

Arm Title

Intrauterine gel-injection therapy group

Arm Type

Experimental

Arm Description

Intrauterine gel-injection therapy group apply intrauterine gel-injection therapy after surgery.

Arm Title

Healthy control group

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Intrauterine lavage therapy

Intervention Description

Intrauterine lavage treatment was performed within 3 to 7 days after the first menstrual period after surgery.

Intervention Type

Drug

Intervention Name(s)

Intrauterine gel-injection therapy

Intervention Description

Intrauterine gel-injection treatment was performed within 3 to 7 days after the first menstrual period after surgery.

Primary Outcome Measure Information:

Title

Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Menstruation Pattern(Improvement or No Significant Change) of All Participants

Description

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.

Time Frame

1 year

Title

Reduction of American Fertility Society adhesion score at Second-look

Description

Time Frame

one year

Title

Number of Participants With Pregnancy after operation

Time Frame

two years

Title

Differences in distribution of reproductive tract bacteria between patients are before and after operation

Time Frame

one year

Title

Differences in distribution of reproductive tract bacteria between healthy control group and intrauterine adhesion patients

Time Frame

one year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yaling Guo, master

Phone

15622327162

1106561876@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yuqing Chen, Deputy chief

Phone

13724067575

fangchenyq@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuqing Chen, Deputy chief

Organizational Affiliation

First Affiliated Hospital, Sun Yat-Sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangzhou

City

Guangdong

State/Province

Guangzhou, Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yaling Guo, Master

Phone

15622327162

1106561876@qq.com

First Name & Middle Initial & Last Name & Degree

Yuqing Chen, Chief

Phone

13724067575

fangchenyq@163.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

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Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

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