Uterine SeptumNCT02617108
Intrauterine Balloon and Postoperative Estrogen Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
A study testing Foley balloon in people with Uterine Septum, run by Fu Xing Hospital, Capital Medical University.
Trial summary
Patients who want to go TCRS will randomly divided 3 groups. In Group 1(100 patients), women received postoperative estrogen therapy. In Group 2 (100 patients), a Foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five… Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Uterine Septum
- What is being tested?
- Foley balloon
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Nov 2021
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who will go hysteroscopic transection of uterine septum between 2016 to 2017 at the Hysteroscopy Center, Fuxing Hospital;
- Patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions;
- Written informed consent obtained.
Who cannot join
- ongoing pregnancy;
- Peroperative fever or infections;
- Malignancy;
- Precious pelvic inflammatory disease;
- Uterine fibroid (>3cm size);
- endometriosis;
- Contraindications for anesthesia;
- Not able to read and/or understand informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized, Controlled Trial Comparing the Efficacy of Intrauterine Balloon and Postoperative Estrogen Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Patients who want to go TCRS will randomly divided 3 groups. In Group 1(100 patients), women received postoperative estrogen therapy. In Group 2 (100 patients), a Foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days. In Group 3 (110 patients), women will not receive any of the treatment (comparison group). All subjects underwent two further hysteroscopy, one and three months after the initial surgery. At the second or third look hysteroscopy, the incidence of intra-uterine adhesion will be analyzed.
Read the detailed description
The uterine septum (US) is the most common congenital uterine malformation, accounting for about 75% of Mullerian anomalies. Transcervical resection of septum (TCRS) has been shown in several cohort studies to improve outcome, although evidence from prospectively conducted randomized trial is lacking. TCRS is generally considered to be safe but there is a concern that it may be complicated by post-operative formation of intrauterine adhesions. Some investigators therefore recommend the use of postoperative adjuvant therapies with a view to preventing adhesion formation, as in the case of hysteroscopic surgery for Asherman syndrome. The adjuvant measures proposed include postoperative estrogen therapy, the placement of an intrauterine device (IUD) or Foley catheter in the uterine cavity. Unlike the case of Asherman syndrome in which these various adjuvant therapies are often used and appear to be of benefit, it is uncertain if any of these adjuvant measures are of benefit or necessary in the case TCRS. In this study, the investigators will compare the postoperative adhesion formation rates who will receive Foley catheter therapies 、postoperative estrogen therapy and those who will not receive any therapies to determine the usefulness of Foley catheter therapies in reducing postoperative adhesion formation.
- Conditions
- Uterine Septum
- Being tested
- Foley balloon
- Keywords
- uterine septum, intrauterine adhesions, Foley balloon
- Medical subject headings
- Septate Uterus, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley balloonDevice
a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.
| Study group | Role | What they receive |
|---|---|---|
| Foley balloon | Experimental | Foley balloon following TCRS: a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days. Receives: Device: Foley balloon |
| control groups | No intervention | control groups: women will not receive any therapy of the treatment (comparison group). |
| postoperative estrogen therapy groups | Experimental | Subjects received postoperative hormone therapy as per the protocol in use in our center for Asherman Syndrome. Immediately after the operation, the subjects were started on a 3- month course of cyclical hormonal therapy, consisting of orally administrated oestradiol valerate 2-4mg/day for 21 days, orally administrated medroxyprogesterone acetate 8mg /day from day 12 to 21 of the oestradiol valerate therapy. The second treatment cycle started one week after the completion of the first cycle, and the third treatment cycle started one week after the second cycle. Receives: Device: Foley balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison of the presence and severity(American Fertility Society score) of intra-uterine adhesions at second look and third look hysteroscopy
the incidence and severity of adhesions (as measured according to the American Fertility Society scoring system) between the groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startDec 2019 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Uterine SeptumStudies 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
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Xing Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Yu, Fu Xing Hospital, Capital Medical University
- Investigators
- Tinchiu Li, Ph.D., Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617108
- Sponsor's protocol ID
- FuXingH2
- Status last verified
- Sep 2019
- First submitted
- 23 Nov 2015
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hassan MA, Lavery SA, Trew GH. Congenital uterine anomalies and their impact on fertility. Womens Health (Lond). 2010 May;6(3):443-61. doi: 10.2217/whe.10.19.
PubMed 20426609Brucker SY, Rall K, Campo R, Oppelt P, Isaacson K. Treatment of congenital malformations. Semin Reprod Med. 2011 Mar;29(2):101-12. doi: 10.1055/s-0031-1272472. Epub 2011 Mar 24.
PubMed 21437824Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7.
PubMed 23932377Conforti A, Alviggi C, Mollo A, De Placido G, Magos A. The management of Asherman syndrome: a review of literature. Reprod Biol Endocrinol. 2013 Dec 27;11:118. doi: 10.1186/1477-7827-11-118.
PubMed 24373209
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial Comparing the Efficacy of Intrauterine Balloon and Postoperative Estrogen Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
- ClinicalTrials.gov ID
- NCT02617108
- Acronym / sponsor ID
- FuXingH2
- Conditions
- Uterine Septum
- Keywords
- uterine septum, intrauterine adhesions, Foley balloon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Fu Xing Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 30 Nov 2015 (estimated)
- 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.
Patients who want to go TCRS will randomly divided 3 groups. In Group 1(100 patients), women received postoperative estrogen therapy. In Group 2 (100 patients), a Foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days. In Group 3 (110 patients), women will not receive any of the treatment (comparison group). All subjects underwent two further hysteroscopy, one and three months after the initial surgery. At the second or third look hysteroscopy, the incidence of intra-uterine adhesion will be analyzed.
Detailed description
The uterine septum (US) is the most common congenital uterine malformation, accounting for about 75% of Mullerian anomalies. Transcervical resection of septum (TCRS) has been shown in several cohort studies to improve outcome, although evidence from prospectively conducted randomized trial is lacking. TCRS is generally considered to be safe but there is a concern that it may be complicated by post-operative formation of intrauterine adhesions. Some investigators therefore recommend the use of postoperative adjuvant therapies with a view to preventing adhesion formation, as in the case of hysteroscopic surgery for Asherman syndrome. The adjuvant measures proposed include postoperative estrogen therapy, the placement of an intrauterine device (IUD) or Foley catheter in the uterine cavity. Unlike the case of Asherman syndrome in which these various adjuvant therapies are often used and appear to be of benefit, it is uncertain if any of these adjuvant measures are of benefit or necessary in the case TCRS. In this study, the investigators will compare the postoperative adhesion formation rates who will receive Foley catheter therapies 、postoperative estrogen therapy and those who will not receive any therapies to determine the usefulness of Foley catheter therapies in reducing postoperative adhesion formation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Foley balloon | Experimental | Device: Foley balloonFoley balloon following TCRS: a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days. |
| control groups | No intervention | –control groups: women will not receive any therapy of the treatment (comparison group). |
| postoperative estrogen therapy groups | Experimental | Device: Foley balloonSubjects received postoperative hormone therapy as per the protocol in use in our center for Asherman Syndrome. Immediately after the operation, the subjects were started on a 3- month course of cyclical hormonal therapy, consisting of orally administrated oestradiol valerate 2-4mg/day for 21 days, orally administrated medroxyprogesterone acetate 8mg /day from day 12 to 21 of the oestradiol valerate therapy. The second treatment cycle started one week after the completion of the first cycle, and the third treatment cycle started one week after the second cycle. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who will go hysteroscopic transection of uterine septum between 2016 to 2017 at the Hysteroscopy Center, Fuxing Hospital;
- Patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions;
- Written informed consent obtained.
Key exclusion criteria (8 listed)
- ongoing pregnancy;
- Peroperative fever or infections;
- Malignancy;
- Precious pelvic inflammatory disease;
- Uterine fibroid (>3cm size);
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 |
|---|---|---|
| Foley balloona Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days. | Device | Foley balloon, postoperative estrogen therapy groups |
Primary outcome
A comparison of the presence and severity(American Fertility Society score) of intra-uterine adhesions at second look and third look hysteroscopy
Time frame: 1 year
the incidence and severity of adhesions (as measured according to the American Fertility Society scoring system) between the groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Background: PubMed 20426609Hassan MA, Lavery SA, Trew GH. Congenital uterine anomalies and their impact on fertility. Womens Health (Lond). 2010 May;6(3):443-61. doi: 10.2217/whe.10.19.
- Background: PubMed 21437824Brucker SY, Rall K, Campo R, Oppelt P, Isaacson K. Treatment of congenital malformations. Semin Reprod Med. 2011 Mar;29(2):101-12. doi: 10.1055/s-0031-1272472. Epub 2011 Mar 24.
- Background: PubMed 23932377Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7.
- Background: PubMed 24373209Conforti A, Alviggi C, Mollo A, De Placido G, Magos A. The management of Asherman syndrome: a review of literature. Reprod Biol Endocrinol. 2013 Dec 27;11:118. doi: 10.1186/1477-7827-11-118.
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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, Ph.D. study director
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Foley balloon in people with Uterine Septum, run by Fu Xing Hospital, Capital Medical University.
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 3 inclusion and 8 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 2 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Xiao, Ph.D. (+86-18601262217, 729995176@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A comparison of the presence and severity(American Fertility Society score) of intra-uterine adhesions at second look and third look hysteroscopy (time frame: 1 year). 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 NCT02617108, which also lists 4 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 2 Oct 2019.