Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

Sun Yat-sen University

Status: Unknown

Conditions: Intrauterine Adhesions

Treatments: Drug: Intrauterine gel-injection therapy; Drug: Intrauterine lavage therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03731689

Intrauterine adhesions

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Control group

No Intervention group

Description:

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

Intrauterine lavage therapy group

Experimental group

Description:

Intrauterine lavage therapy group apply intrauterine lavage therapy after surgery.

Treatment:

Drug: Intrauterine lavage therapy

Intrauterine gel-injection therapy group

Experimental group

Description:

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

Treatment:

Drug: Intrauterine gel-injection therapy

Healthy control group

No Intervention group

Description:

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.