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Intrauterine AdhesionNCT02744716

Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion

A study testing Aspirin and intrauterine balloon in people with Intrauterine Adhesion, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 . Read more about this study

Who is it for?
Ages 21 to 40 years, women only
Conditions the study is for
Intrauterine Adhesion
What is being tested?
Aspirin and intrauterine balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteChina
Study dates
May 2011to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

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

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 .

Read the 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.

Being tested
Aspirin, intrauterine balloon
Keywords
intrauterine balloon, uterine endometrial repair, intrauterine adhesion, aspirin
Medical subject headings
Gynatresia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    Also called low dose of Aspirin

    low dose of Aspirin after operation

  • intrauterine balloonDevice

    Also called Balloon stent

    insert intrauterine balloon after operation

Study groups in NCT02744716
Study groupRoleWhat they receive
non-balloon groupExperimentalwith aspirin
Receives: Drug: Aspirin
balloon groupExperimentalwith aspirin and intrauterine balloon
Receives: Drug: Aspirin; Device: intrauterine balloon
control groupNo interventionwithout aspirin and intrauterine balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound

    Measured: Within the first 3 months after surgery

Secondary outcomes (3)

  1. 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.

    Measured: Within the first 3 months after surgery

  2. 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.

    Measured: Within the first 3 months after surgery

  3. Number of Participants With Pregnancy after operation

    Measured: three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2016 (estimated)
  2. Study startMay 2011
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02744716
Sponsor's protocol ID
aspirin
Status last verified
Apr 2016
First submitted
9 Apr 2016
Last updated
20 Apr 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 20656564

  • 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.

    PubMed 23433831

  • 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.

    PubMed 21757423

  • 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.

    PubMed 18406834

  • 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.

    PubMed 23826415

  • 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.

    PubMed 7844233

  • 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.

    PubMed 20335572

  • 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.

    PubMed 25467040

  • 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.

    PubMed 3371491

  • 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.

    PubMed 24959821

  • 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.

    PubMed 25936237

  • 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.

    PubMed 24795547

  • 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.

    PubMed 26559098

Questions about this trial

What is this clinical trial studying?

A study testing Aspirin and intrauterine balloon in people with Intrauterine Adhesion, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound (time frame: Within the first 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02744716, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.

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