Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02744716
Other study ID # aspirin
Secondary ID
Status Completed
Phase N/A
First received April 9, 2016
Last updated April 16, 2016
Start date May 2011
Est. completion date January 2016

Study information

Verified date April 2016
Source First Affiliated Hospital, Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority China: Health and Family Planning Commission of Guangdong Province
Study type Interventional

Clinical Trial 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 .


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.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 40 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Aspirin
low dose of Aspirin after operation
Device:
intrauterine balloon
insert intrauterine balloon after operation

Locations

Country Name City State
China the First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (13)

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. Review. — View Citation

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;11:113-127. Epub 2014 Mar 14. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Kaandorp SP, Goddijn M, van der Post JA, Hutten BA, Verhoeve HR, Hamulyák K, Mol BW, Folkeringa N, Nahuis M, Papatsonis DN, Büller 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, müllerian anomalies and intrauterine adhesions. Fertil Steril. 1988 Jun;49(6):944-55. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound Within the first 3 months after surgery No
Secondary 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. Within the first 3 months after surgery No
Secondary 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. Within the first 3 months after surgery No
Secondary Number of Participants With Pregnancy after operation three years No
See also
  Status Clinical Trial Phase
Recruiting NCT04972032 - Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis N/A
Recruiting NCT03381807 - Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion Early Phase 1
Recruiting NCT03329898 - Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion N/A
Completed NCT03724617 - Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium N/A
Recruiting NCT03330873 - The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome N/A
Completed NCT02220621 - Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion N/A
Active, not recruiting NCT04963179 - PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film. N/A
Recruiting NCT03351205 - The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis N/A
Completed NCT04381728 - PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film N/A
Recruiting NCT03346317 - Comparing the Efficacy of Two Methods in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis N/A
Completed NCT05414760 - Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier N/A
Completed NCT04166500 - Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion N/A
Recruiting NCT03169478 - Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Formation After Hysteroscopic Myomectomy N/A
Recruiting NCT03171454 - Immediate and Delayed Intrauterine Balloon in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis N/A
Recruiting NCT05003869 - Clinical and Basic Research on the Necessity of Scar Tissue Resection During Intrauterine Adhesions N/A
Completed NCT03131596 - Postoperative Intermittent Intrauterine Balloon Dilatation Therapy. N/A
Completed NCT04824430 - Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions Following Endometrial Ablation
Completed NCT01167296 - Safety of Leaving Cook Balloon Uterine Stent in Uterus for One Month Phase 4
Completed NCT03578172 - HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients N/A
Recruiting NCT04930913 - Three-dimensional Ultrasound Applying in Assessment of Intrauterine Adhesions