CompletedNot Applicable

The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion

300 participantsStarted 2016-07-01

Plain-language summary

Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined.

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.

The inclusion criteria: * Patients to be female, aged 18-45 years * Without previous dilatation and curettage * Undergoing dilatation and curettage for the current delayed miscarriage * All participants should be with normal liver/rental function and without systemic disease * Agree to use adequate forms of contraception throughout the study * Be in good compliance with the follow-up examination according to the study protocol. The exclusion criteria: * Known/suspected intolerance or hypersensitivity to hyaluronan or its derivatives * Genital tract malformation * Inflammation of genital tract or pelvic cavity, clinical evidence of cancer in genital tract * Suspected genital tuberculosis * Abnormal blood coagulation * Medical histories of peripheral vascular disease, alcohol/drug abuse, and mental illness * Acute or severe infection * Autoimmune diseases.

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

Incidence of intrauterine adhesion

Timeframe: 3 months after dilatation and curettage

Trial details

NCT IDNCT03353909

SponsorBioRegen Biomedical (CHangzhou) Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-02-15

View on ClinicalTrials.gov More Intrauterine Adhesion trials