Clinical trial NCT03731689: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Intrauterine Adhesions
Keywords: intrauterine lavage therapy
hysteroscopy
microbiome
uterine endometrial repair
intrauterine gel-injection therapy
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
timeFrame: 1 year
Secondary outcomes:
measure: Menstruation Pattern(Improvement or No Significant Change) of All Participants
timeFrame: 1 year
measure: Reduction of American Fertility Society adhesion score at Second-look
timeFrame: one year
measure: Number of Participants With Pregnancy after operation
timeFrame: two years
measure: Differences in distribution of reproductive tract bacteria between patients are before and after operation
timeFrame: one year
measure: Differences in distribution of reproductive tract bacteria between healthy control group and intrauterine adhesion patients
timeFrame: one year
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Guangzhou
state: Guangzhou, Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Yuqing Chen, Deputy chief
role: PRINCIPAL_INVESTIGATOR
References: