Intrauterine AdhesionNCT03171454
Immediate and Delayed Intrauterine Balloon in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
A study testing Delayed Intrauterine Balloon therapy and immediate Intrauterine Balloon therapy in people with Intrauterine Adhesion, run by Fu Xing Hospital, Capital Medical University at 1 site in China.
Trial summary
In this prospective, randomized, controlled study, the investigators wish to compare the efficacy of immediate and delayed intrauterine balloon (IUB) therapy in the prevention of adhesion reformation after hysteroscopic adhesiolysis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- Delayed Intrauterine Balloon therapy and immediate Intrauterine Balloon therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2017to 31 Dec 2018
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women aged 18-40 years;
- moderate to severe intrauterine adhesion (AFS score≥5);
- first episode of hysteroscopicadhesiolysis in our hospital;
- written consent obtained;
- agreement to have second-look hysteroscopy.
Who cannot join
- minimal adhesion (AFS score <5)
- previous hysteroscopic adhesiolysis in our hospital.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fu Xing Hospital
Beijing, Beijing Municipality, 100038
Lei Guo, +86 010-88062291, guolei.yale@163.com
Tinchiu Li, tinchiuli@gmail.com
About this study
Official title: Randomized, Controlled Trial Comparing Immediate and Delayed Intrauterine Balloon Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
In this prospective, randomized, controlled study, the investigators wish to compare the efficacy of immediate and delayed intrauterine balloon (IUB) therapy in the prevention of adhesion reformation after hysteroscopic adhesiolysis.
Read the detailed description
Objectives
To compare the efficacy of placing an Intrauterine Balloon immediately after surgery and delayed Intrauterine Balloon Dilatation Therapy after surgery in the prevention of adhesion reformation after hysteroscopic adhesiolysis.
Patients
The patients will be recruited from two centers, namely, the HysterscopyCenter of the Fuxing Hospital and TianTan Hospital, Capital Medical University, Beijing, China.Before the surgery all patients with suspected Asherman syndrome will undergo preoperative evaluations, including a detailed history of the menstrual pattern, any previous intrauterine surgery, and reproductive history, as well as trans-vaginal ultrasonography.The severity and extent of intrauterine adhesions will be scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version). The inclusion criteria include [1] women aged 18-40 years; [2] moderate to severe intrauterine adhesion (AFS score≥5); [3] first episode of hysteroscopic adhesiolysis in the investigators hospital; [4] written consent obtained; and [5] agreement to have second-look hysteroscopy. The exclusion criteria include [1] minimal adhesion (AFS score <5) and [2] previous hysteroscopic adhesiolysis in the investigators hospital.
Study Design
At the conclusion of hysteroscopic adhesiolysis, recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: [1] Immediate Intrauterine Balloon therapy (I-IUB) group: Immediately place a Foley-catheter intrauterine balloon which will be removed after 7 days after surgery; [2] Delayed Intrauterine Balloon therapy (D-IUB) group： insertion of a Foley-catheter to distend the uterine cavity 2 weeks and 4 weeks after hysteroscopic adhesiolysis; A second-look hysteroscopy will be carried out in the early proliferative phase 6 weeks after the surgery.
Power Calculation
On the basis of the results of the two published retrospective cohort studies comparing the balloon and hormone therapy group (control group) in the prevention of adhesion reformation, the investigators estimate that the adhesion reformation rate in the immediate balloon group to be 30% and in the delayed balloon group to be 10%. Accepting a type 1 error of 0.05, and a type 2 error of 0.10, the number of subjects in each arm of the randomized, controlled trial would be 79. Assuming that the dropout rate to be 20%, the total number of subject to be recruited would be 90 in each arm.
Procedure
Surgical procedure
The surgery will be carried out by one of three experienced hysteroscopic surgeons with the use of a 8.5-mm rigid hysteroscope (Olympus) with 0.9% normal saline infusion under 100-120 mmHg pressure. The procedure will be performed under general anesthesia in a day surgery unit. Ultrasonographic guidance will be routinely used. Once the extent and severity of uterine adhesion has been assessed, the adhesions will be divided with the use of bipolar instrument until normal uterine anatomy is achieved.At the conclusion of the surgery, in the immediate balloon group: a Foley-catheter will be immediately inserted into the uterine cavity and the balloon will be distended with 5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days. In the delayed balloon group,a Foley catheter will be inserted into the uterine cavity 2 weeks after the surgery, the balloon will be inflated with normal saline (from 3-5ml) then deflated, and the procedure repeated three time over 3 minutes or so, then the cavity will be flushed with 10 mls of normal saline solution after via the irrigating channel of the Foley catheter before removal. The whole procedure will be repeated a further 2 weeks later.
Postoperative treatments
All subjects will be treated with oral antibiotics for 5 days. In all cases hormone therapy will also begin from the day of operation, consisting of estradiol at a dose of 2 mg, bid for 21- 28 days, with the addition of dydrogesterone at a dose of 10 mg, bid for the last 10 days of the estrogen therapy. After the withdrawal bleed, the hormone therapy will be repeated for another cycle. Second-look hysteroscopy will be carried out in the early proliferative phase, 6 weeks after the initial operation. After assessment of the extent and severity of any reformed adhesion, hysteroscopic adhesiolysis will also be carried out at the time of the second-look procedure, if adhesion has recurred. The surgeon who performs the second-look hysteroscopy will be blinded to the randomization.
IUB dilatation
D-IUB dilatation therapy group will be performed using a Foley catheter and according to the methodology published in the literature. This will be prepared by cutting the catheter tip protruding beyond the balloon. Once the catheter has reached the fundus, 5mls of saline will be slowly instilled into the balloon under ultrasound guidance.
Statistical Analysis
The rate of the recurrence of adhesion in the two groups will be compared using the χ2 test. The reduction of AFS score in the two groups will be compared using the Mann-Whitney U test. A p value of < 0.05 will be considered statistically significant. All statistical analysis will be carried out with the use of SPSS 21.0.
Outcome measures
The primary outcome measure will include the degree of intrauterine adhesions and AFS score at follow-up. The secondary outcome measures will include the change of menstrual pattern after surgery and the need for re-operation.The third outcome measures will include any complications including any clinicalinfection.
Data processing and analysis
The researchers will ensure the confidentiality of sensitive data by minimizing the number of personnel who handle subject data. In addition, computer data will be encrypted as required to maximize security, while paper documents will be locked in filing cabinets, with only authorized personnel having access to the information.
Ethical considerations
IUB dilatation has been published as a novel technique with no untoward complications identified to date. The procedure will be performed according to the methodology available in the literature and the study has gained approval from the local ethical committee.
Consent
All subjects will be given a detailed explanation of the study and sufficient time to consider participants. A written consent form will be signed by the patient and retained in the investigators confidential records
- Conditions
- Intrauterine Adhesion
- Being tested
- Delayed Intrauterine Balloon therapy, immediate Intrauterine Balloon therapy
- Keywords
- hysteroscopic operation, intrauterine balloon, adhesions
- Medical subject headings
- Gynatresia, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed Intrauterine Balloon therapyProcedure or surgery
D-IUB dilatation therapy group will be performed using a (size 12-14fr) Foley catheter and according to the methodology published in the literature. This will be prepared by cutting the catheter tip protruding beyond the balloon. Once the catheter has reached the fundus, 5mls of saline will be slowly instilled into the balloon under ultrasound guidance.
immediate Intrauterine Balloon therapyProcedure or surgery
At the conclusion of the surgery, in the immediate balloon group: a Foley-catheter will be immediately inserted into the uterine cavity and the balloon will be distended with 4-5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Intrauterine Balloon therapy | Experimental | In the delayed balloon group,a Foley catheter will be inserted into the uterine cavity 2 weeks after the surgery, the balloon will be inflated with normal saline (from 3ml to 5ml) then deflated, and the procedure repeated three time over 3 minutes or so, then the cavity will be flushed with 10 mls of normal saline solution after via the irrigating channel of the Foley catheter before removal. The whole procedure will be repeated a further 2 weeks later. Receives: Procedure: Delayed Intrauterine Balloon therapy |
| immediate Intrauterine Balloon therapy | Experimental | At the conclusion of the surgery, in the immediate balloon group: a Foley-catheter will be immediately inserted into the uterine cavity and the balloon will be distended with 5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days. Receives: Procedure: immediate Intrauterine Balloon therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
AFS score
The degree of intrauterine adhesions described by AFS score reduction at second look hysteroscopy
Measured: at 6 weeks post-op
Secondary outcomes (2)
The menstrual pattern
Menstrual blood loss figure before and after surgery
Measured: at 6 weeks post-op
infection rate
Secretion bacteria culture
Measured: at 6 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start30 May 2017
- Primary completion30 Sep 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Intrauterine AdhesionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Xing Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Principal investigator, Xiaoyu Shi, Fu Xing Hospital, Capital Medical University
- Investigators
- Tinchiu Li, Study chair, Fu Xing Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171454
- Sponsor's protocol ID
- 2017FXHEC-KY006
- Status last verified
- Jun 2017
- First submitted
- 25 May 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
March CM. Intrauterine adhesions. Obstet Gynecol Clin North Am. 1995 Sep;22(3):491-505.
PubMed 8524533Saravelos SH, Li TC. Ultrasound-guided treatment of intrauterine adhesions in the outpatient setting. Ultrasound Obstet Gynecol. 2017 Aug;50(2):278-280. doi: 10.1002/uog.16218. No abstract available.
PubMed 27420903Saravelos SH and Li TC. Intrauterine balloon therapy: a novel ultrasound guided treatment for intrauterine adhesions. Gynecological Surgery [Epub ahead of print]
Saravelos SH, Jayaprakasan K, Ojha K, Li TC. Assessment of the uterus with three-dimensional ultrasound in women undergoing ART. Hum Reprod Update. 2017 Mar 1;23(2):188-210. doi: 10.1093/humupd/dmw040.
PubMed 28007752Orhue 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 12834941Taskin O, Sadik S, Onoglu A, Gokdeniz R, Erturan E, Burak F, Wheeler JM. Role of endometrial suppression on the frequency of intrauterine adhesions after resectoscopic surgery. J Am Assoc Gynecol Laparosc. 2000 Aug;7(3):351-4. doi: 10.1016/s1074-3804(05)60478-1.
PubMed 10924629Healy MW, Schexnayder B, Connell MT, Terry N, DeCherney AH, Csokmay JM, Yauger BJ, Hill MJ. Intrauterine adhesion prevention after hysteroscopy: a systematic review and meta-analysis. Am J Obstet Gynecol. 2016 Sep;215(3):267-275.e7. doi: 10.1016/j.ajog.2016.05.001. Epub 2016 May 10.
PubMed 27173082Guida M, Acunzo G, Di Spiezio Sardo A, Bifulco G, Piccoli R, Pellicano M, Cerrota G, Cirillo D, Nappi C. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Hum Reprod. 2004 Jun;19(6):1461-4. doi: 10.1093/humrep/deh238. Epub 2004 Apr 22.
PubMed 15105384Roge P, D'Ercole C, Cravello L, Boubli L, Blanc B. Hysteroscopic management of uterine synechiae: a series of 102 observations. Eur J Obstet Gynecol Reprod Biol. 1996 Apr;65(2):189-93. doi: 10.1016/0301-2115(95)02342-9.
PubMed 8730623Schenker JG. Etiology of and therapeutic approach to synechia uteri. Eur J Obstet Gynecol Reprod Biol. 1996 Mar;65(1):109-13. doi: 10.1016/0028-2243(95)02315-j.
PubMed 8706941Pabuccu R, Atay V, Orhon E, Urman B, Ergun A. Hysteroscopic treatment of intrauterine adhesions is safe and effective in the restoration of normal menstruation and fertility. Fertil Steril. 1997 Dec;68(6):1141-3. doi: 10.1016/s0015-0282(97)00375-0.
PubMed 9418714
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial Comparing Immediate and Delayed Intrauterine Balloon Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
- ClinicalTrials.gov ID
- NCT03171454
- Acronym / sponsor ID
- 2017FXHEC-KY006
- Conditions
- Intrauterine Adhesion
- Keywords
- hysteroscopic operation, intrauterine balloon, adhesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fu Xing Hospital, Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 30 May 2017 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective, randomized, controlled study, the investigators wish to compare the efficacy of immediate and delayed intrauterine balloon (IUB) therapy in the prevention of adhesion reformation after hysteroscopic adhesiolysis.
Detailed description
Objectives
To compare the efficacy of placing an Intrauterine Balloon immediately after surgery and delayed Intrauterine Balloon Dilatation Therapy after surgery in the prevention of adhesion reformation after hysteroscopic adhesiolysis.
Patients
The patients will be recruited from two centers, namely, the HysterscopyCenter of the Fuxing Hospital and TianTan Hospital, Capital Medical University, Beijing, China.Before the surgery all patients with suspected Asherman syndrome will undergo preoperative evaluations, including a detailed history of the menstrual pattern, any previous intrauterine surgery, and reproductive history, as well as trans-vaginal ultrasonography.The severity and extent of intrauterine adhesions will be scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version). The inclusion criteria include [1] women aged 18-40 years; [2] moderate to severe intrauterine adhesion (AFS score≥5); [3] first episode of hysteroscopic adhesiolysis in the investigators hospital; [4] written consent obtained; and [5] agreement to have second-look hysteroscopy. The exclusion criteria include [1] minimal adhesion (AFS score <5) and [2] previous hysteroscopic adhesiolysis in the investigators hospital.
Study Design
At the conclusion of hysteroscopic adhesiolysis, recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: [1] Immediate Intrauterine Balloon therapy (I-IUB) group: Immediately place a Foley-catheter intrauterine balloon which will be removed after 7 days after surgery; [2] Delayed Intrauterine Balloon therapy (D-IUB) group： insertion of a Foley-catheter to distend the uterine cavity 2 weeks and 4 weeks after hysteroscopic adhesiolysis; A second-look hysteroscopy will be carried out in the early proliferative phase 6 weeks after the surgery.
Power Calculation
On the basis of the results of the two published retrospective cohort studies comparing the balloon and hormone therapy group (control group) in the prevention of adhesion reformation, the investigators estimate that the adhesion reformation rate in the immediate balloon group to be 30% and in the delayed balloon group to be 10%. Accepting a type 1 error of 0.05, and a type 2 error of 0.10, the number of subjects in each arm of the randomized, controlled trial would be 79. Assuming that the dropout rate to be 20%, the total number of subject to be recruited would be 90 in each arm.
Procedure
Surgical procedure
The surgery will be carried out by one of three experienced hysteroscopic surgeons with the use of a 8.5-mm rigid hysteroscope (Olympus) with 0.9% normal saline infusion under 100-120 mmHg pressure. The procedure will be performed under general anesthesia in a day surgery unit. Ultrasonographic guidance will be routinely used. Once the extent and severity of uterine adhesion has been assessed, the adhesions will be divided with the use of bipolar instrument until normal uterine anatomy is achieved.At the conclusion of the surgery, in the immediate balloon group: a Foley-catheter will be immediately inserted into the uterine cavity and the balloon will be distended with 5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days. In the delayed balloon group,a Foley catheter will be inserted into the uterine cavity 2 weeks after the surgery, the balloon will be inflated with normal saline (from 3-5ml) then deflated, and the procedure repeated three time over 3 minutes or so, then the cavity will be flushed with 10 mls of normal saline solution after via the irrigating channel of the Foley catheter before removal. The whole procedure will be repeated a further 2 weeks later.
Postoperative treatments
All subjects will be treated with oral antibiotics for 5 days. In all cases hormone therapy will also begin from the day of operation, consisting of estradiol at a dose of 2 mg, bid for 21- 28 days, with the addition of dydrogesterone at a dose of 10 mg, bid for the last 10 days of the estrogen therapy. After the withdrawal bleed, the hormone therapy will be repeated for another cycle. Second-look hysteroscopy will be carried out in the early proliferative phase, 6 weeks after the initial operation. After assessment of the extent and severity of any reformed adhesion, hysteroscopic adhesiolysis will also be carried out at the time of the second-look procedure, if adhesion has recurred. The surgeon who performs the second-look hysteroscopy will be blinded to the randomization.
IUB dilatation
D-IUB dilatation therapy group will be performed using a Foley catheter and according to the methodology published in the literature. This will be prepared by cutting the catheter tip protruding beyond the balloon. Once the catheter has reached the fundus, 5mls of saline will be slowly instilled into the balloon under ultrasound guidance.
Statistical Analysis
The rate of the recurrence of adhesion in the two groups will be compared using the χ2 test. The reduction of AFS score in the two groups will be compared using the Mann-Whitney U test. A p value of < 0.05 will be considered statistically significant. All statistical analysis will be carried out with the use of SPSS 21.0.
Outcome measures
The primary outcome measure will include the degree of intrauterine adhesions and AFS score at follow-up. The secondary outcome measures will include the change of menstrual pattern after surgery and the need for re-operation.The third outcome measures will include any complications including any clinicalinfection.
Data processing and analysis
The researchers will ensure the confidentiality of sensitive data by minimizing the number of personnel who handle subject data. In addition, computer data will be encrypted as required to maximize security, while paper documents will be locked in filing cabinets, with only authorized personnel having access to the information.
Ethical considerations
IUB dilatation has been published as a novel technique with no untoward complications identified to date. The procedure will be performed according to the methodology available in the literature and the study has gained approval from the local ethical committee.
Consent
All subjects will be given a detailed explanation of the study and sufficient time to consider participants. A written consent form will be signed by the patient and retained in the investigators confidential records
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Intrauterine Balloon therapy | Experimental | Procedure: Delayed Intrauterine Balloon therapyIn the delayed balloon group,a Foley catheter will be inserted into the uterine cavity 2 weeks after the surgery, the balloon will be inflated with normal saline (from 3ml to 5ml) then deflated, and the procedure repeated three time over 3 minutes or so, then the cavity will be flushed with 10 mls of normal saline solution after via the irrigating channel of the Foley catheter before removal. The whole procedure will be repeated a further 2 weeks later. |
| immediate Intrauterine Balloon therapy | Experimental | Procedure: immediate Intrauterine Balloon therapyAt the conclusion of the surgery, in the immediate balloon group: a Foley-catheter will be immediately inserted into the uterine cavity and the balloon will be distended with 5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women aged 18-40 years;
- moderate to severe intrauterine adhesion (AFS score≥5);
- first episode of hysteroscopicadhesiolysis in our hospital;
- written consent obtained;
- agreement to have second-look hysteroscopy.
Key exclusion criteria (2 listed)
- minimal adhesion (AFS score <5)
- previous hysteroscopic adhesiolysis in our hospital.
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 |
|---|---|---|
| Delayed Intrauterine Balloon therapyD-IUB dilatation therapy group will be performed using a (size 12-14fr) Foley catheter and according to the methodology published in the literature. This will be prepared by cutting the catheter tip protruding beyond the balloon. Once the catheter has reached the fundus, 5mls of saline will be slowly instilled into the balloon under ultrasound guidance. | Procedure or surgery | Delayed Intrauterine Balloon therapy |
| immediate Intrauterine Balloon therapyAt the conclusion of the surgery, in the immediate balloon group: a Foley-catheter will be immediately inserted into the uterine cavity and the balloon will be distended with 4-5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days. | Procedure or surgery | immediate Intrauterine Balloon therapy |
Primary outcome
AFS score
Time frame: at 6 weeks post-op
The degree of intrauterine adhesions described by AFS score reduction at second look hysteroscopy
2 secondary outcomes
The menstrual pattern
Time frame: at 6 weeks post-op
infection rate
Time frame: at 6 weeks post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Background: PubMed 8524533March CM. Intrauterine adhesions. Obstet Gynecol Clin North Am. 1995 Sep;22(3):491-505.
- Results publication: PubMed 27420903Saravelos SH, Li TC. Ultrasound-guided treatment of intrauterine adhesions in the outpatient setting. Ultrasound Obstet Gynecol. 2017 Aug;50(2):278-280. doi: 10.1002/uog.16218. No abstract available.
- Results publicationSaravelos SH and Li TC. Intrauterine balloon therapy: a novel ultrasound guided treatment for intrauterine adhesions. Gynecological Surgery [Epub ahead of print]
- Results publication: PubMed 28007752Saravelos SH, Jayaprakasan K, Ojha K, Li TC. Assessment of the uterus with three-dimensional ultrasound in women undergoing ART. Hum Reprod Update. 2017 Mar 1;23(2):188-210. doi: 10.1093/humupd/dmw040.
- 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.
- Results publication: PubMed 10924629Taskin O, Sadik S, Onoglu A, Gokdeniz R, Erturan E, Burak F, Wheeler JM. Role of endometrial suppression on the frequency of intrauterine adhesions after resectoscopic surgery. J Am Assoc Gynecol Laparosc. 2000 Aug;7(3):351-4. doi: 10.1016/s1074-3804(05)60478-1.
- Results publication: PubMed 27173082Healy MW, Schexnayder B, Connell MT, Terry N, DeCherney AH, Csokmay JM, Yauger BJ, Hill MJ. Intrauterine adhesion prevention after hysteroscopy: a systematic review and meta-analysis. Am J Obstet Gynecol. 2016 Sep;215(3):267-275.e7. doi: 10.1016/j.ajog.2016.05.001. Epub 2016 May 10.
- Results publication: PubMed 15105384Guida M, Acunzo G, Di Spiezio Sardo A, Bifulco G, Piccoli R, Pellicano M, Cerrota G, Cirillo D, Nappi C. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Hum Reprod. 2004 Jun;19(6):1461-4. doi: 10.1093/humrep/deh238. Epub 2004 Apr 22.
- Results publication: PubMed 8730623Roge P, D'Ercole C, Cravello L, Boubli L, Blanc B. Hysteroscopic management of uterine synechiae: a series of 102 observations. Eur J Obstet Gynecol Reprod Biol. 1996 Apr;65(2):189-93. doi: 10.1016/0301-2115(95)02342-9.
- Results publication: PubMed 8706941Schenker JG. Etiology of and therapeutic approach to synechia uteri. Eur J Obstet Gynecol Reprod Biol. 1996 Mar;65(1):109-13. doi: 10.1016/0028-2243(95)02315-j.
- Results publication: PubMed 9418714Pabuccu R, Atay V, Orhon E, Urman B, Ergun A. Hysteroscopic treatment of intrauterine adhesions is safe and effective in the restoration of normal menstruation and fertility. Fertil Steril. 1997 Dec;68(6):1141-3. doi: 10.1016/s0015-0282(97)00375-0.
- Individual participant dataSharing planned: Undecided
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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.
Tinchiu Li study chair
Fu Xing Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed Intrauterine Balloon therapy and immediate Intrauterine Balloon therapy in people with Intrauterine Adhesion, run by Fu Xing Hospital, Capital Medical 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Jun 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Guo (+86 15810635320, guolei.yale@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AFS score (time frame: at 6 weeks post-op). 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 NCT03171454, which also lists 11 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 7 Jun 2017.