Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion

Sun Yat-sen University

Status: Completed

Conditions: Intrauterine Adhesion

Treatments: Device: intrauterine balloon; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02744716

aspirin

Details and patient eligibility

About

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 .

Full description

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.

Enrollment: 114 patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 3 patient groups

non-balloon group

Experimental group

Description:

with aspirin

Treatment:

Drug: Aspirin

balloon group

Experimental group

Description:

with aspirin and intrauterine balloon

Treatment:

Drug: Aspirin

Device: intrauterine balloon

control group

No Intervention group

Description:

without aspirin and intrauterine balloon