Clinical trial NCT02744716: Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Adhesion
Keywords: intrauterine balloon
uterine endometrial repair
intrauterine adhesion
aspirin
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 114
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
timeFrame: Within the first 3 months after surgery
Secondary outcomes:
measure: Menstruation Pattern(Improvement or No Significant Change) of All Participants
timeFrame: Within the first 3 months after surgery
measure: Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants
timeFrame: Within the first 3 months after surgery
measure: Number of Participants With Pregnancy after operation
timeFrame: three years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: chen yu qing, Deputy chief
role: PRINCIPAL_INVESTIGATOR
References:
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