Arcuate UterusNCT03384082
A Randomised Controlled Trial of Hysteroscopic Resection of Mild Septum/Arcuate Uteri.
A study testing hysteroscopic treatment in people with Arcuate Uterus, run by Fu Xing Hospital, Capital Medical University at 1 site in China.
Trial summary
At least 82 cases of recurrent miscarriage women with a diagnosis of arcuate uterus, confirmed by three-dimensional intra-vaginal sonography (3D-TVS) and hysteroscopy, will be recruited. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Arcuate Uterus
- What is being tested?
- hysteroscopic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2019to 1 Jan 2022
- 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
- Women with arcuate/mild septum uteri
- Women with unexplained recurrent miscarriage (less than 12 weeks)
- Having a second time fertility requirement
- Having Informed consent before entering this study, and be willing to receive hysteroscopic treatment
Who cannot join
- 3D-TVS and hysteroscopy suggest uterine fibroids (submucosal and III type uterine fibroids, intramural fibroids,the diameter of whichis greater than 4cm), adenomyosis, endometrial polyps, intrauterine adhesions and other uterine factors that may lead to spontaneous abortion
- Endometrial pathological diagnosis of chronic endometritis, endometrial hyperplasia and endometrial cancer
- Ultrasound or HSG suggest hydrosalpinx
- Chromosome abnormalities of the couples, positive findings of pre-thrombosis state and the detection of immunity, uterine malformation, uterine fibroids, adenomyosis and other uterine factors causing recurrent miscarriage
- Semen abnormality in male
- FSH > 10
Trial locations and contacts
1 site in 1 country.
Yu Xiao, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Hysteroscopic Centre of Fuxing Hospital
Beijing
Dongmei Song
About this study
Official title: A Randomised Controlled Trial of Hysteroscopic Resection of Mild Septum/Arcuate Uteri in Women With Recurrent Miscarriage.
At least 82 cases of recurrent miscarriage women with a diagnosis of arcuate uterus, confirmed by three-dimensional intra-vaginal sonography (3D-TVS) and hysteroscopy, will be recruited. The subjects will be randomly divided into two groups, the experimental group will be given hysteroscopic treatment, the control group will receive no treatment. The pregnancy rates (>12 weeks) of the two groups will befollowed and compared.
Read the detailed description
This study will be carried out at the Hysteroscopy center of the Fuxing Hospital, Beijing, China. At least 82 recurrent miscarriage women with a diagnosis of arcuate uterus who had unexplained recurrent spontaneous abortion (less than 12 weeks) before and have fertility requirement will be recruited. The patients will be explained the study and sign the informed consent. According to the random number table, the corresponding cases were divided into treatment group and control group. The experimental group will be given hysteroscopic treatment, the control group will receive no treatment. The follow up of the spontaneous abortion rate and the pregnancy rate of two groups will be screened within 1-2 years and the correlation between the arcuate uterus and recurrent miscarriage will be analyzed.
- Conditions
- Arcuate Uterus
- Being tested
- hysteroscopic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysteroscopic treatmentProcedure or surgery
treatment
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopic treatment | Experimental | Hysteroscopic surgery Receives: Procedure: hysteroscopic treatment |
| Control group | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pregnancy rate(>12 weeks)of the two groups
The pregnancy rate(>12 weeks) of the two groups after receiving hysteroscopic treatment and no treatment.
Measured: 2 years
The spontaneous abortion rate of the two groups
The spontaneous abortion rate of the two groups after receiving hysteroscopic treatment and no treatment.
Measured: 2 years
The live birth rate of the two groups
Te live birth rate of the two groups after receiving hysteroscopic treatment and no treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start22 Feb 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arcuate UterusStudies 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
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Xing Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Dongmei, Fu Xing Hospital, Capital Medical University
- Investigators
- Dongmei Song, Ph.D, Study chair, Fuxing Hospital, Capital Medical UniversityTinchiu Li, Ph.D, Study director, Prince of Wales Hospital, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384082
- Sponsor's protocol ID
- FuXingH02
- Status last verified
- Mar 2020
- First submitted
- 13 Dec 2017
- Last updated
- 5 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Hysteroscopic Resection of Mild Septum/Arcuate Uteri in Women With Recurrent Miscarriage.
- ClinicalTrials.gov ID
- NCT03384082
- Acronym / sponsor ID
- FuXingH02
- Conditions
- Arcuate Uterus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Fu Xing Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 27 Dec 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.
At least 82 cases of recurrent miscarriage women with a diagnosis of arcuate uterus, confirmed by three-dimensional intra-vaginal sonography (3D-TVS) and hysteroscopy, will be recruited. The subjects will be randomly divided into two groups, the experimental group will be given hysteroscopic treatment, the control group will receive no treatment. The pregnancy rates (>12 weeks) of the two groups will befollowed and compared.
Detailed description
This study will be carried out at the Hysteroscopy center of the Fuxing Hospital, Beijing, China. At least 82 recurrent miscarriage women with a diagnosis of arcuate uterus who had unexplained recurrent spontaneous abortion (less than 12 weeks) before and have fertility requirement will be recruited. The patients will be explained the study and sign the informed consent. According to the random number table, the corresponding cases were divided into treatment group and control group. The experimental group will be given hysteroscopic treatment, the control group will receive no treatment. The follow up of the spontaneous abortion rate and the pregnancy rate of two groups will be screened within 1-2 years and the correlation between the arcuate uterus and recurrent miscarriage will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopic treatment | Experimental | Procedure: hysteroscopic treatmentHysteroscopic surgery |
| Control group | No intervention | –No treatment |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with arcuate/mild septum uteri
- Women with unexplained recurrent miscarriage (less than 12 weeks)
- Having a second time fertility requirement
- Having Informed consent before entering this study, and be willing to receive hysteroscopic treatment
Key exclusion criteria (6 listed)
- 3D-TVS and hysteroscopy suggest uterine fibroids (submucosal and III type uterine fibroids, intramural fibroids,the diameter of whichis greater than 4cm), adenomyosis, endometrial polyps, intrauterine adhesions and other uterine factors that may lead to spontaneous abortion
- Endometrial pathological diagnosis of chronic endometritis, endometrial hyperplasia and endometrial cancer
- Ultrasound or HSG suggest hydrosalpinx
- Chromosome abnormalities of the couples, positive findings of pre-thrombosis state and the detection of immunity, uterine malformation, uterine fibroids, adenomyosis and other uterine factors causing recurrent miscarriage
- Semen abnormality in male
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 |
|---|---|---|
| hysteroscopic treatmenttreatment | Procedure or surgery | Hysteroscopic treatment |
Primary outcome
The pregnancy rate(>12 weeks)of the two groups
Time frame: 2 years
The pregnancy rate(>12 weeks) of the two groups after receiving hysteroscopic treatment and no treatment.
The spontaneous abortion rate of the two groups
Time frame: 2 years
The spontaneous abortion rate of the two groups after receiving hysteroscopic treatment and no treatment.
The live birth rate of the two groups
Time frame: 2 years
Te live birth rate of the two groups after receiving hysteroscopic treatment and no treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Individual participant dataSharing planned: Yes
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.
Yu Xiao, Ph.D contact
Dongmei Song, Ph.D study chair
Fuxing Hospital, Capital Medical University
Tinchiu Li, Ph.D study director
Prince of Wales Hospital, Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hysteroscopic treatment in people with Arcuate Uterus, 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 4 inclusion and 6 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 5 Mar 2020. 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 Dongmei Song, Ph.D (88062220, echosdm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pregnancy rate(>12 weeks)of the two groups (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2020.