Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion

Study Overview
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Brief Summary
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This study aimed To investigate the effects of estrogen in combination with aspirin and intrauterine balloon on the uterine endometrial repair and reproductive prognosis in patients after surgery for severe intrauterine adhesion .

Detailed Description
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This cohort study was conducted to investigate whether aspirin could promote the endometrial growth and repair, reduce the recurrence of intrauterine adhesion and improve the menstruation and reproductive prognosis after surgery for severe intrauterine adhesion. Menstruation was evaluated for the first time with a method similar to visual analogue scale (VAS) in which the menstruation was assessed by the patients themselves with 0 as amenorrhea and 100 as normal menstruation. This evaluation avoids the vague terms (such as large or small menstrual blood volume) in previous evaluations and considers the individual difference in menstrual blood volume and different understanding about the menstrual blood volume. Thus, this evaluation is easy to master, quantify and analyze.

Official Title
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Effects of Aspirin and Intrauterine Balloon on the Post-operative Uterine Endometrial Repair and Reproductive Prognosis in Patients With Severe Intrauterine Adhesion: a Prospective Cohort Study

Conditions
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Intrauterine Adhesion

Intervention / Treatment
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* Drug: Aspirin
* Device: intrauterine balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-operative adhesion score was ≥9 The prior menstrual cycle was regular, and the sex hormone was normal Patients had fertility requirement Male semen examination showed normal; (5) There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery Exclusion Criteria: Pre-operative adhesion score was <9 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 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-balloon group<br>with aspirin | Drug: Aspirin<br>* low dose of Aspirin after operation<br>* Other names: low dose of Aspirin;|
| Experimental: balloon group<br>with aspirin and intrauterine balloon | Drug: Aspirin<br>* low dose of Aspirin after operation<br>* Other names: low dose of Aspirin;Device: intrauterine balloon<br>* insert intrauterine balloon after operation<br>* Other names: Balloon stent;|
| No Intervention: control group<br>without aspirin and intrauterine balloon | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound |  | Within the first 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstruation Pattern(Improvement or No Significant Change) of All Participants | A method similar to VAS was employed for the evaluation of post-operative menstruation with 0 as amenorrhea and 100 as normal menstruation. | Within the first 3 months after surgery | 
| Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants | 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. | Within the first 3 months after surgery | 
| Number of Participants With Pregnancy after operation |  | three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intrauterine balloon, uterine endometrial repair, intrauterine adhesion, aspirin