Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion

First Affiliated Hospital, Sun Yat-Sen University114 enrolled

Overview

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 .

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

114

Conditions

Intrauterine Adhesion

Interventions

AspirinDRUG

low dose of Aspirin after operation

intrauterine balloonDEVICE

insert intrauterine balloon after operation

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

the First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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

Time frame: Within the first 3 months after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: Within the first 3 months after surgery

Number of Participants With Pregnancy after operation

Time frame: three years

Data from ClinicalTrials.gov

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