Intrauterine AdhesionNCT04930913
Three-dimensional Ultrasound Applying in Assessment of Intrauterine Adhesions
An observational study of Intrauterine Adhesion, run by Fu Xing Hospital, Capital Medical University at 1 site in China.
Trial summary
In this prospective, multicenter, large-scale study，the investigators wish to examine the accuracy of several three-dimensional ultrasound anatomical and vascular parameters in diagnosing IUA when compared to the gold standard of hysteroscopy，and to assess the value of 3D US applying in prognosis of intrauterine… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- Three-dimensional Ultrasound
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Jun 2023
- Phase
- Observational
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 600 patients from three Tertiary hospitals suspected of having IUA will be prospectively recruited
Who may be able to join
- women aged 20-40
- oligomenorrhea or amenorrhea
- BMI 18-30
- regular menstruation
- written consent obtained
Who cannot join
- Hypothalamic amenorrhea, pituitary amenorrhea and ovarian amenorrhea
- Patients with uterine fibroids, adenomyosis, uterine malformation and endometrial polyps
- Patients with uterine artery embolization
- History of endometrial hyperplasia
- Irregular menstruation
- Patients with severe complications
- Patients with hypoovarian function
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fu Xing Hospital, Capital Medical University
Beijing, 100038
luo wen, +86 010-88062291, fxyykjk@sina.com
About this study
Official title: The Value of Three-dimensional Ultrasound Applying in Pre and Postoperative Assessment and Prognosis of Intrauterine Adhesions
In this prospective, multicenter, large-scale study，the investigators wish to examine the accuracy of several three-dimensional ultrasound anatomical and vascular parameters in diagnosing IUA when compared to the gold standard of hysteroscopy，and to assess the value of 3D US applying in prognosis of intrauterine adhesions.
Read the detailed description
- Study Design This is a prospective, multicenter, large-scale diagnostic testing. We use hysteroscopy finding as standard reference.
- Study population 600 patients from three tertiary hospitals suspected of having IUA will be prospectively recruited. Thorough assessment including previous reproductive and surgical history as well as menstrual pattern will be performed.
- Study Procedure 3.1 Diagnosis
IUA will be diagnosed in coronal plane, based on a suggestion reported by a Taiwanese study. The morphological characteristics of the endometrium suggesting IUA include as follow:
- marginal irregularity (in coronal plane)
- defects (interrupted endometrial line)
- obliteration (undetectable endometrium suggesting extensive adhesion)
- fibrosis or calcification (hyperechoic lesion without posterior shadowing, or with posterior shadowing) 3.2 Ultrasound
- Transvaginal Ultrasound will be performed in luteal phase.
- Using E10 Voluson GE with 3D/4D TV probe.
- Scan and rendering will be performed in a standardized technique (omniview mode).
- Several parameters will be measured including endometrial volume, uterine volume, vascularization (VI FI VFI).
3.3 Hysteroscopy
- Hysteroscopic exam will be used as the gold standard for the diagnosis of intrauterine adhesions.
- hysteroscopy will confirm the presence, extent, and morphological characteristics of adhesions and the quality of the endometrium.
3.4 Surgical technique
- Hysteroscopic surgery will be performed in a standardized manner.
- The severity and extent of intrauterine adhesions will be scored according to different classification systems. (ESGE/AFS/China consensus)
- a Foley-catheter filled with 3.0ml normal saline will be inserted into the uterus for 5-7 days after surgery.
3.5 Postoperative treatments
- All subjects will be treated with Hormone therapy for at least 8 weeks
- A second-look hysteroscopy will be carried out 4 weeks after surgery, a third-look hysteroscopy will be carried out 12 weeks after surgery
- A second-look 3D US will be carried out in luteal phase after two menstrual peroid postoperatively.
3.6 Follow up
- Follow-up styles: the doctor's outpatient review, telephone, WeChat and so on.
- Follow-up time:3 months, 6months, 12 months after the operation.
- Follow up the results of hysteroscopy and 3D US at 3 months after the operation and the menstrual improvement at 6months after the operation and pregnancy outcomes at 12 months after the operation
- Conditions
- Intrauterine Adhesion
- Being tested
- Three-dimensional Ultrasound
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional UltrasoundDiagnostic test
women suspected of having adhesions will perform 3D US
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial volume
Endometrial volume will be measured in in luteal phase by 3D US
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 posted18 Jun 2021
- Study start1 Jul 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Xing Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaowu Huang, Fu Xing Hospital, Capital Medical University
- Investigators
- Li Tinchiu, Study chair, Fuxing Hospital,Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930913
- Sponsor's protocol ID
- 2020-1-7027
- Status last verified
- Jun 2021
- First submitted
- 11 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim MJ, Lee Y, Lee C, Chun S, Kim A, Kim HY, Lee JY. Accuracy of three dimensional ultrasound and treatment outcomes of intrauterine adhesion in infertile women. Taiwan J Obstet Gynecol. 2015 Dec;54(6):737-41. doi: 10.1016/j.tjog.2015.10.011.
PubMed 26700995Amin TN, Saridogan E, Jurkovic D. Ultrasound and intrauterine adhesions: a novel structured approach to diagnosis and management. Ultrasound Obstet Gynecol. 2015 Aug;46(2):131-9. doi: 10.1002/uog.14927. Epub 2015 Jul 20. No abstract available.
PubMed 26094824Carrascosa P, Capunay C, Vallejos J, Carpio J, Baronio M, Papier S. Two-dimensional and three-dimensional imaging of uterus and fallopian tubes in female infertility. Fertil Steril. 2016 Jun;105(6):1403-1420.e7. doi: 10.1016/j.fertnstert.2016.04.016. Epub 2016 Apr 29.
PubMed 27140290AAGL Elevating Gynecologic Surgery. AAGL practice report: practice guidelines on intrauterine adhesions developed in collaboration with the European Society of Gynaecological Endoscopy (ESGE). Gynecol Surg. 2017;14(1):6. doi: 10.1186/s10397-017-1007-3. Epub 2017 May 1. No abstract available.
PubMed 28603474Salazar CA, Isaacson K, Morris S. A comprehensive review of Asherman's syndrome: causes, symptoms and treatment options. Curr Opin Obstet Gynecol. 2017 Aug;29(4):249-256. doi: 10.1097/GCO.0000000000000378.
PubMed 28582327Dreisler E, Kjer JJ. Asherman's syndrome: current perspectives on diagnosis and management. Int J Womens Health. 2019 Mar 20;11:191-198. doi: 10.2147/IJWH.S165474. eCollection 2019.
PubMed 30936754
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Three-dimensional Ultrasound Applying in Pre and Postoperative Assessment and Prognosis of Intrauterine Adhesions
- ClinicalTrials.gov ID
- NCT04930913
- Acronym / sponsor ID
- 2020-1-7027
- Conditions
- Intrauterine Adhesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fu Xing Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 18 Jun 2021 (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, multicenter, large-scale study，the investigators wish to examine the accuracy of several three-dimensional ultrasound anatomical and vascular parameters in diagnosing IUA when compared to the gold standard of hysteroscopy，and to assess the value of 3D US applying in prognosis of intrauterine adhesions.
Detailed description
- Study Design This is a prospective, multicenter, large-scale diagnostic testing. We use hysteroscopy finding as standard reference.
- Study population 600 patients from three tertiary hospitals suspected of having IUA will be prospectively recruited. Thorough assessment including previous reproductive and surgical history as well as menstrual pattern will be performed.
- Study Procedure 3.1 Diagnosis
IUA will be diagnosed in coronal plane, based on a suggestion reported by a Taiwanese study. The morphological characteristics of the endometrium suggesting IUA include as follow:
- marginal irregularity (in coronal plane)
- defects (interrupted endometrial line)
- obliteration (undetectable endometrium suggesting extensive adhesion)
- fibrosis or calcification (hyperechoic lesion without posterior shadowing, or with posterior shadowing) 3.2 Ultrasound
- Transvaginal Ultrasound will be performed in luteal phase.
- Using E10 Voluson GE with 3D/4D TV probe.
- Scan and rendering will be performed in a standardized technique (omniview mode).
- Several parameters will be measured including endometrial volume, uterine volume, vascularization (VI FI VFI).
3.3 Hysteroscopy
- Hysteroscopic exam will be used as the gold standard for the diagnosis of intrauterine adhesions.
- hysteroscopy will confirm the presence, extent, and morphological characteristics of adhesions and the quality of the endometrium.
3.4 Surgical technique
- Hysteroscopic surgery will be performed in a standardized manner.
- The severity and extent of intrauterine adhesions will be scored according to different classification systems. (ESGE/AFS/China consensus)
- a Foley-catheter filled with 3.0ml normal saline will be inserted into the uterus for 5-7 days after surgery.
3.5 Postoperative treatments
- All subjects will be treated with Hormone therapy for at least 8 weeks
- A second-look hysteroscopy will be carried out 4 weeks after surgery, a third-look hysteroscopy will be carried out 12 weeks after surgery
- A second-look 3D US will be carried out in luteal phase after two menstrual peroid postoperatively.
3.6 Follow up
- Follow-up styles: the doctor's outpatient review, telephone, WeChat and so on.
- Follow-up time:3 months, 6months, 12 months after the operation.
- Follow up the results of hysteroscopy and 3D US at 3 months after the operation and the menstrual improvement at 6months after the operation and pregnancy outcomes at 12 months after the operation
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 600 patients from three Tertiary hospitals suspected of having IUA will be prospectively recruited
Key inclusion criteria (5 listed)
- women aged 20-40
- oligomenorrhea or amenorrhea
- BMI 18-30
- regular menstruation
- written consent obtained
Key exclusion criteria (7 listed)
- Hypothalamic amenorrhea, pituitary amenorrhea and ovarian amenorrhea
- Patients with uterine fibroids, adenomyosis, uterine malformation and endometrial polyps
- Patients with uterine artery embolization
- History of endometrial hyperplasia
- Irregular menstruation
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 |
|---|---|---|
| Three-dimensional Ultrasoundwomen suspected of having adhesions will perform 3D US | Diagnostic test | – |
Primary outcome
Endometrial volume
Time frame: 1 year
Endometrial volume will be measured in in luteal phase by 3D US
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Background: PubMed 26700995Kim MJ, Lee Y, Lee C, Chun S, Kim A, Kim HY, Lee JY. Accuracy of three dimensional ultrasound and treatment outcomes of intrauterine adhesion in infertile women. Taiwan J Obstet Gynecol. 2015 Dec;54(6):737-41. doi: 10.1016/j.tjog.2015.10.011.
- Background: PubMed 26094824Amin TN, Saridogan E, Jurkovic D. Ultrasound and intrauterine adhesions: a novel structured approach to diagnosis and management. Ultrasound Obstet Gynecol. 2015 Aug;46(2):131-9. doi: 10.1002/uog.14927. Epub 2015 Jul 20. No abstract available.
- Background: PubMed 27140290Carrascosa P, Capunay C, Vallejos J, Carpio J, Baronio M, Papier S. Two-dimensional and three-dimensional imaging of uterus and fallopian tubes in female infertility. Fertil Steril. 2016 Jun;105(6):1403-1420.e7. doi: 10.1016/j.fertnstert.2016.04.016. Epub 2016 Apr 29.
- Background: PubMed 28603474AAGL Elevating Gynecologic Surgery. AAGL practice report: practice guidelines on intrauterine adhesions developed in collaboration with the European Society of Gynaecological Endoscopy (ESGE). Gynecol Surg. 2017;14(1):6. doi: 10.1186/s10397-017-1007-3. Epub 2017 May 1. No abstract available.
- Background: PubMed 28582327Salazar CA, Isaacson K, Morris S. A comprehensive review of Asherman's syndrome: causes, symptoms and treatment options. Curr Opin Obstet Gynecol. 2017 Aug;29(4):249-256. doi: 10.1097/GCO.0000000000000378.
- Background: PubMed 30936754Dreisler E, Kjer JJ. Asherman's syndrome: current perspectives on diagnosis and management. Int J Womens Health. 2019 Mar 20;11:191-198. doi: 10.2147/IJWH.S165474. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Li Tinchiu study chair
Fuxing 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?
An observational study of 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 7 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 18 Jun 2021. 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 Huang xiaowu (+8613810828816, hxiaowu_fxyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial volume (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 NCT04930913, which also lists 6 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 18 Jun 2021.