Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

Intrauterine Adhesions Clinical Trial

Official title:

Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03731689
• Other study ID #: Intrauterine adhesions
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2018
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Yaling Guo, master
• Phone: 15622327162
• Email: 1106561876[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intrauterine Adhesions
• Tissue Adhesions

Intervention

Drug:
• Intrauterine lavage therapy
Intrauterine lavage treatment was performed within 3 to 7 days after the first menstrual period after surgery.
• Intrauterine gel-injection therapy
Intrauterine gel-injection treatment was performed within 3 to 7 days after the first menstrual period after surgery.

Locations

Country	Name	City	State
China	Guangzhou	Guangdong	Guangzhou, Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound		1 year
Secondary	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
Secondary	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
Secondary	Number of Participants With Pregnancy after operation		two years
Secondary	Differences in distribution of reproductive tract bacteria between patients are before and after operation		one year
Secondary	Differences in distribution of reproductive tract bacteria between healthy control group and intrauterine adhesion patients		one year