ArticleBMJ open2025
Role of the collagen scaffold in preventing intrauterine adhesion from recurrence after adhesiolysis: protocol for a multicentre, randomised, controlled, parallel-group, open-label, superiority clinical trial.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Prognostic Factors and Predictive Models for Reproductive Outcomes in Patients with Intrauterine Adhesions: A Review.International journal of women's health · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIntrauterine adhesions (IUAs) are one of the most common causes of uterine infertility. Hysteroscopic adhesiolysis is the primary treatment for IUA, but the rate of IUA recurrence is high in moderate to severe cases. While traditional guidelines recommend placing a non-copper stainless steel intrauterine device (IUD) into the uterine cavity after adhesiolysis to prevent readhesion, the preventive effect is uncertain. Our preliminary trials suggested that the collagen scaffold was more effective in moderate cases. This study aims to assess the efficacy and safety of a collagen scaffold versus IUD in preventing readhesion after hysteroscopic adhesiolysis in patients with moderate IUA. METHODS AND ANALYSIS: This multicentre, open-label, randomised controlled trial evaluates the efficacy and safety of a collagen scaffold compared with an IUD in preventing readhesion after hysteroscopic adhesiolysis in women with moderate IUA. This trial will be conducted at six teaching hospitals and plans to enrol 200 participants. The primary outcome is the non-recurrence rate of IUA 2 months after adhesiolysis. Secondary endpoints include changes in American Fertility Society scores before and after surgery and postoperative menstrual blood volume. The 95% CIs for the difference in non-recurrence rates between the two groups will be calculated. If the lower limit of this interval exceeds the superiority threshold of zero, the conclusion of superiority is confirmed. ETHICS AND DISSEMINATION: This study has received approval from the ethics committee of the Affiliated Drum Tower Hospital of Nanjing University Medical School (2022-491-02) and the ethics committees of the participating centres. Written informed consent will be obtained from each participant before starting any study procedures. The results of this trial will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ChiCTR2300068271.
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