- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02744716
Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion
April 16, 2016 updated by: Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University
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
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 .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- The First Affiliated Hospital of Sun Yat-Sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: non-balloon group
with aspirin
|
low dose of Aspirin after operation
Other Names:
|
Experimental: balloon group
with aspirin and intrauterine balloon
|
low dose of Aspirin after operation
Other Names:
insert intrauterine balloon after operation
Other Names:
|
No Intervention: control group
without aspirin and intrauterine balloon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
Time Frame: Within the first 3 months after surgery
|
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
Time Frame: Within the first 3 months after surgery
|
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
Time Frame: Within the first 3 months after surgery
|
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
Time Frame: three years
|
three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: chen yu qing, Deputy chief, First Affiliated Hospital, Sun Yat-Sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096.
- The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, mullerian anomalies and intrauterine adhesions. Fertil Steril. 1988 Jun;49(6):944-55. doi: 10.1016/s0015-0282(16)59942-7. No abstract available.
- Bosteels J, Weyers S, Kasius J, Broekmans FJ, Mol BW, D'Hooghe TM. Anti-adhesion therapy following operative hysteroscopy for treatment of female subfertility. Cochrane Database Syst Rev. 2015 Nov 9;(11):CD011110. doi: 10.1002/14651858.CD011110.pub2.
- Kaandorp SP, Goddijn M, van der Post JA, Hutten BA, Verhoeve HR, Hamulyak K, Mol BW, Folkeringa N, Nahuis M, Papatsonis DN, Buller HR, van der Veen F, Middeldorp S. Aspirin plus heparin or aspirin alone in women with recurrent miscarriage. N Engl J Med. 2010 Apr 29;362(17):1586-96. doi: 10.1056/NEJMoa1000641. Epub 2010 Mar 24.
- Lin XN, Zhou F, Wei ML, Yang Y, Li Y, Li TC, Zhang SY. Randomized, controlled trial comparing the efficacy of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis. Fertil Steril. 2015 Jul;104(1):235-40. doi: 10.1016/j.fertnstert.2015.04.008. Epub 2015 Apr 30.
- Deans R, Abbott J. Review of intrauterine adhesions. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):555-69. doi: 10.1016/j.jmig.2010.04.016. Epub 2010 Jul 24.
- Yang JH, Chen MJ, Chen CD, Chen SU, Ho HN, Yang YS. Optimal waiting period for subsequent fertility treatment after various hysteroscopic surgeries. Fertil Steril. 2013 Jun;99(7):2092-6.e3. doi: 10.1016/j.fertnstert.2013.01.137. Epub 2013 Feb 22.
- Sedgh G, Singh S, Henshaw SK, Bankole A. Legal abortion worldwide in 2008: levels and recent trends. Int Perspect Sex Reprod Health. 2011 Jun;37(2):84-94. doi: 10.1363/3708411.
- Chen Y, Chang Y, Yao S. Role of angiogenesis in endometrial repair of patients with severe intrauterine adhesion. Int J Clin Exp Pathol. 2013 Jun 15;6(7):1343-50. Print 2013.
- Wada I, Hsu CC, Williams G, Macnamee MC, Brinsden PR. The benefits of low-dose aspirin therapy in women with impaired uterine perfusion during assisted conception. Hum Reprod. 1994 Oct;9(10):1954-7. doi: 10.1093/oxfordjournals.humrep.a138366.
- Lin YH, Jang TN, Hwang JL, Huang LW, Seow KM, Hsieh BC, Huang CH. Bacterial colonization with balloon uterine stent placement in the uterus for 30 days: a randomized controlled clinical trial. Fertil Steril. 2015 Feb;103(2):513-8.e2. doi: 10.1016/j.fertnstert.2014.10.032. Epub 2014 Nov 20.
- Evans-Hoeker EA, Young SL. Endometrial receptivity and intrauterine adhesive disease. Semin Reprod Med. 2014 Sep;32(5):392-401. doi: 10.1055/s-0034-1376358. Epub 2014 Jun 24.
- Bosteels J, Weyers S, Mol BW, D'Hooghe T. Anti-adhesion barrier gels following operative hysteroscopy for treating female infertility: a systematic review and meta-analysis. Gynecol Surg. 2014;11(2):113-127. doi: 10.1007/s10397-014-0832-x. Epub 2014 Mar 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
April 9, 2016
First Submitted That Met QC Criteria
April 16, 2016
First Posted (Estimate)
April 20, 2016
Study Record Updates
Last Update Posted (Estimate)
April 20, 2016
Last Update Submitted That Met QC Criteria
April 16, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Fibrosis
- Cicatrix
- Tissue Adhesions
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- Aspirin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intrauterine Adhesion
-
Hua DuanRecruitingIntrauterine Adhesion | Database for Intrauterine Adhesion | Risk Factors for Intrauterine Adhesion | Risk Stratification and Prognostic AssessmentChina
-
The Fourth Affiliated Hospital of Zhejiang University...Recruiting
-
Rejoni Inc.CompletedIntrauterine AdhesionUnited States
-
Ain Shams Maternity HospitalCompletedIntrauterine AdhesionEgypt
-
Fu Xing Hospital, Capital Medical UniversityBeijing Tiantan HospitalUnknown
-
Rejoni Inc.RecruitingIntrauterine AdhesionUnited States
-
Limin FengRecruitingIntrauterine AdhesionChina
-
Fu Xing Hospital, Capital Medical UniversityRecruitingIntrauterine AdhesionChina
-
Second Affiliated Hospital, School of Medicine,...Shanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaRecruitingIntrauterine AdhesionChina
-
WomedCompletedIntrauterine AdhesionBelgium, France, Netherlands
Clinical Trials on Aspirin
-
The First Affiliated Hospital with Nanjing Medical...UnknownCoronary AtherosclerosisChina
-
Seoul National University HospitalCKD Pharmaceutical LimitedCompleted
-
Queen Mary University of LondonCancer Research UK; Barts and the London School of Medicine and DentistryCompletedProstate CancerUnited Kingdom
-
FANG HERecruitingPreeclampsia | Perinatal HaemorrhageChina
-
University of VigoRecruiting
-
Seoul National University HospitalCompletedCoronary Artery DiseaseKorea, Republic of
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingPulmonary Disease, Chronic ObstructiveUnited States
-
Seoul National University HospitalCompletedHealthyKorea, Republic of
-
PLx PharmaCompletedDiabetes Mellitus, Type 2United States
-
Boehringer IngelheimCompletedCoronary ArteriosclerosisIreland