Asherman's SyndromeROABTIPWSIUANCT02708277

Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions

A study testing loop-shaped intrauterine contraceptive device and intrauterine balloon (Cook Medical) in people with Asherman's Syndrome, run by Yuqing Chen.

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

The purpose of this study is to compare the outcome of loop intrauterine contraceptive device and heart-shaped intrauterine balloon for the adjunctive treatment of severe intrauterine adhesions in patients with infertility. Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Asherman's Syndrome
What is being tested?: loop-shaped intrauterine contraceptive device and intrauterine balloon (Cook Medical)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: No sites listed yet
Study dates: Jan 2011to Mar 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Clinical diagnosis of severe intrauterine adhesions
infertility

Who cannot join

endometrial tuberculosis
grossly abnormal semen analysis
ovarian failure, hydrosalpinx fluid
patients who did not proceed to second-look hysteroscopy within the specified time frame
Women with no desire to pregnancy

About this study

Official title: Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions.

Read the detailed description

Intrauterine adhesion, also known as Asherman's syndrome, is the partial or complete occlusion of the uterine cavity as a result of endometrium damage. Most intrauterine adhesions patients manifest amenorrhea, reduced menstrual pattern, infertility, and intrauterine growth restriction, which seriously affect their reproductive health. Currently, hysteroscopy is the preferred method of intrauterine adhesions diagnosis and treatment. However, because intrauterine adhesions patients generally have poor endometrium repair capability, the incidence rate of reformation of intrauterine adhesions ranging from 20%-62.5% in those with severe adhesions. The successful pregnancy rate after treatment in severe Asherman's syndrome is reported to be consistently lower, only 33%. The prevention of intrauterine adhesions recurrence after trans-cervical resection of adhesion is clinically important but difficult. Therefore, this study was conducted.

Conditions: Asherman's Syndrome
Being tested: loop-shaped intrauterine contraceptive device, intrauterine balloon (Cook Medical)
Keywords: intrauterine contraceptive device, intrauterine balloon
Medical subject headings: Gynatresia

What participants receive

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

loop-shaped intrauterine contraceptive deviceDevice
Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation.
intrauterine balloon (Cook Medical)Device
The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device.

Study groups in NCT02708277
Study group	Role	What they receive
Group A	Experimental	At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. Receives: Device: loop-shaped intrauterine contraceptive device
Group B	Experimental	At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. Receives: Device: intrauterine balloon (Cook Medical)

What is being measured

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

Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Measured: three years

Secondary outcomes (3)

Menstruation Pattern(Improvement or No Significant Change) of All Participants
Comparing with preoperative and postoperative menstrual duration, numbers of sanitary napkin using and wet area ratio of sanitary napkin to judgment whether menstrual quantity is improvement in patients
Measured: Within the first 3 months after surgery
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
Measured: Within the first 3 months after surgery
Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Measured: Within the first 3 months after surgery

Timeline

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

Jan 2011Mar 2015

First posted15 Mar 2016 (estimated)
Study startJan 2011
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Asherman's SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02708277
Sponsor's protocol ID: IUA-21
Acronym: ROABTIPWSIUA
Status last verified: Apr 2016
First submitted: 4 Mar 2016
Last updated: 27 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes

Publications

Orhue AA, Aziken ME, Igbefoh JO. A comparison of two adjunctive treatments for intrauterine adhesions following lysis. Int J Gynaecol Obstet. 2003 Jul;82(1):49-56. doi: 10.1016/s0020-7292(03)00030-4.
PubMed 12834941

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Senescent Endometrial Cells in Patients With Thin Endometrial Lining
Asherman's Syndrome, Thin Endometrial Lining
Recruiting
CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)
Asherman Syndrome
RecruitingPhase 1
AD-SVF Therapy for Refractory Endometrial Infertility
Endometrium; Atrophy, Intrauterine Synechiae
RecruitingEarly Phase 1
Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
Asherman Syndrome, Atrophic Endometrium
Not yet recruitingObservational study
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
Intrauterine Abnormalities in Infertility, Asherman Syndrome

All Asherman's Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions.
ClinicalTrials.gov ID: NCT02708277
Acronym / sponsor ID: ROABTIPWSIUA / IUA-21
Conditions: Asherman's Syndrome
Keywords: intrauterine contraceptive device, intrauterine balloon
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Yuqing ChenUniversity, hospital or other
Study start: Jan 2011
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 15 Mar 2016 (estimated)
Results: Posted 27 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Device: loop-shaped intrauterine contraceptive deviceAt the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
Group B	Experimental	Device: intrauterine balloon (Cook Medical)At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Clinical diagnosis of severe intrauterine adhesions
infertility

Key exclusion criteria (5 listed)

endometrial tuberculosis
grossly abnormal semen analysis
ovarian failure, hydrosalpinx fluid
patients who did not proceed to second-look hysteroscopy within the specified time frame
Women with no desire to pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
loop-shaped intrauterine contraceptive deviceIntrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation.	Device	Group A
intrauterine balloon (Cook Medical)The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device.	Device	Group B

Primary outcome

Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Time frame: three years

3 secondary outcomes

Menstruation Pattern(Improvement or No Significant Change) of All Participants
Time frame: Within the first 3 months after surgery
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
Time frame: Within the first 3 months after surgery
Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Time frame: Within the first 3 months after surgery

Results and safety

Results posted to the registry on 27 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Loop-shaped Intrauterine Device Group	50	43
Intrauterine Balloon Group	43	39

Primary outcome: Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group

Time frame: three years. Number. Unit: participants

Measure	Loop-shaped Intrauterine Device Group n = 43	Intrauterine Balloon Group n = 39
Value	12	22

Loop-shaped Intrauterine Device Group vs Intrauterine Balloon Group: p = 0.009, Chi-squared

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Loop-shaped Intrauterine Device Group	0 of 43 (0%)	1 of 43 (2.3%)	Not reported
Intrauterine Balloon Group	0 of 39 (0%)	1 of 39 (2.6%)	Not reported

Limitations and caveats (from the sponsor): This study was conducted in a university hospital.If this was a multicenter study, the results should be more reasonable.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 12834941Orhue AA, Aziken ME, Igbefoh JO. A comparison of two adjunctive treatments for intrauterine adhesions following lysis. Int J Gynaecol Obstet. 2003 Jul;82(1):49-56. doi: 10.1016/s0020-7292(03)00030-4.
Individual participant dataSharing planned: Yes

Related trials for Asherman's Syndrome

RecruitingObservational study
Senescent Endometrial Cells in Patients With Thin Endometrial Lining
Asherman's Syndrome, Thin Endometrial Lining
Recruiting
CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)
Asherman Syndrome
RecruitingPhase 1
AD-SVF Therapy for Refractory Endometrial Infertility
Endometrium; Atrophy, Intrauterine Synechiae
RecruitingEarly Phase 1
Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
Asherman Syndrome, Atrophic Endometrium
Not yet recruitingObservational study
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
Intrauterine Abnormalities in Infertility, Asherman Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shuzhong Yao, professor study director

First Affiliated Hospital, Sun Yat-Sen University

Questions about this trial

What is this clinical trial studying?

A study testing loop-shaped intrauterine contraceptive device and intrauterine balloon (Cook Medical) in people with Asherman's Syndrome, run by Yuqing Chen.

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 2 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 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 27 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group (time frame: three years). 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 NCT02708277, which also lists 1 linked publication.

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 27 May 2016.