Prevention of Intrauterine Adhesions After Hysteroscopic Metroplasty With Autocross-linked Hyalur… (NCT02404454) | Clinical Trial Compass
UnknownNot Applicable
Prevention of Intrauterine Adhesions After Hysteroscopic Metroplasty With Autocross-linked Hyaluronic Acid Gel
50 participantsStarted 2016-06
Plain-language summary
The septate uterus is the most common structural uterine anomaly. It results from failure of the partition between the two fused Müllerian ducts to resorb;it is associated with the highest incidence of reproductive failure and with first- and second-trimester pregnancy loss and infertility.
Hysteroscopic division of the uterine septum is performed using microscissors, electrosurgery, or laser. Several studies shown significant improvement in pregnancy outcome after hysteroscopic metroplasty.
Purpose of this study is to verify the effectiveness of 5 ml, instead of 10 ml, of autocross-linked hyaluronic acid gel in the prevention of the formation of intrauterine adhesions, through second look office hysteroscopy after three months.
Who can participate
Age range
18 Years – 45 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:
* uterine septum
* history of ≥1 miscarriage or infertility;
* desire to have children in the future
Exclusion Criteria:
* pregnancy;
* menopause;
* precancerous state or malignancy of the reproductive organs;
* benign lesions in the myometrium of the uterine fundus (myomas or adenomyosis)
* lesions distorting the uterine cavity (submucosal myomas or intrauterine adhesions) on ultrasonography;
* withdrawal of patient consent;
* rare complex uterine congenital anomalies without an ASRM classification such as uterine septum with double cervix ;
* presence of external intercornual cleft;
* incomplete (internal fundal indentation 10 mm) or non-standardized septum resection (internal fundal indentation ,10 mm and uterine myometrial thickness .10 mm at the fundus), confirmed intraoperatively
* excessive fundal incision (uterine myometrial thickness ,6 mm at the fundus confirmed intraoperatively)
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
Change in Formation of intrauterine adhesions
Timeframe: baseline (operative isteroscopy and three months