A Randomised Controlled Trial of Hysteroscopic Resection of Mild Septum/Arcuate Uteri. (NCT03384082) | Clinical Trial Compass
UnknownNot Applicable
A Randomised Controlled Trial of Hysteroscopic Resection of Mild Septum/Arcuate Uteri.
China82 participantsStarted 2019-02-22
Plain-language 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. 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.
Who can participate
Age range
25 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The pregnancy rate(>12 weeks)of the two groups
Timeframe: 2 years
2
The spontaneous abortion rate of the two groups
Timeframe: 2 years
3
The live birth rate of the two groups
Timeframe: 2 years
Trial details
NCT IDNCT03384082
SponsorFu Xing Hospital, Capital Medical University
. 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