Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion

NCT ID: NCT02744716

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-01-31

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.

Conditions

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Intrauterine Adhesion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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non-balloon group

with aspirin

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

low dose of Aspirin after operation

balloon group

with aspirin and intrauterine balloon

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

low dose of Aspirin after operation

intrauterine balloon

Intervention Type DEVICE

insert intrauterine balloon after operation

control group

without aspirin and intrauterine balloon

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aspirin

low dose of Aspirin after operation

Intervention Type DRUG

intrauterine balloon

insert intrauterine balloon after operation

Intervention Type DEVICE

Other Intervention Names

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low dose of Aspirin Balloon stent

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Yuqing Chen

Deputy chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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chen yu qing, Deputy chief

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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the First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 20656564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23433831 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21757423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18406834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23826415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7844233 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20335572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25467040 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3371491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24959821 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25936237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24795547 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26559098 (View on PubMed)

Other Identifiers

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aspirin

Identifier Type: -

Identifier Source: org_study_id

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