An interventional study of new crosslinked hyaluronan gel in Intrauterine Adhesion, sponsored by BioRegen Biomedical (CHangzhou) Co., Ltd. Completed. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-11-27.
Sponsored by BioRegen Biomedical (CHangzhou) Co., Ltd · Not applicable, Interventional, and Prevention
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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.
Study Objectives: To evaluate the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesions formation after dilatation and curettage.
Design: Randomized controlled trial. Settings: Six hospitals for maternal and child health care in China. Patients: Three hundred women undergoing dilatation and curettage for delayed miscarriage without previous dilatation and curettage.
Interventions: Women were randomly assigned into either dilatation and curettage alone group or dilatation and curettage plus new crosslinked hyaluronan gel application group with 1:1 allocation.
Measurements and Outcomes: All patients were evaluated using American Fertility Society classification of IUAs during the follow-up diagnostic hysteroscopy, scheduled 3 months after dilatation and curettage procedure. The primary outcome was the number of women with IUAs, and the secondary outcome was the adhesion scores and the severity of IUAs.
99 studies on the registry are indexed under Gynatresia; 23 are open to participants now.
This study's enrollment of 300 is above the median of 100 across 87 interventional studies indexed under Gynatresia.
Browse Gynatresia studies →BioRegen Biomedical (CHangzhou) Co., Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.
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The inclusion criteria:
The exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
At the end of the dilatation and curettage, new crosslinked hyaluronan gel (3ml) was applied to the uterine cavity in women assigned to the treatment group through a 15-cm sterile cannula.
Device: new crosslinked hyaluronan gel
At the end of the dilatation and curettage, nothing was applied to the uterine cavity in women assigned to the control group.
At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.
Also known as: MateRegen Gel
Incidence of intrauterine adhesion
The number of women with intrauterine adhesion
Time frame: 3 months after dilatation and curettage
The adhesion scores of extent of uterine cavity involved
Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 1 point (\<1/3 cavity with adhesion), 2 points (1/3-2/3 cavity with adhesion) and 4 points (\>2/3 cavity with adhesion), high values represent worse outcome
Time frame: 3 months after dilatation and curettage
The adhesion scores of type of adhesion
Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 1 point (filmy adhesion), 2 points (filmy \& dense adhesion) and 4 points (dense adhesion), high values represent worse outcome
Time frame: 3 months after dilatation and curettage
The adhesion scores of menstrual pattern
Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 0 point (normal), 2 points (hypomenorrhea) and 4 points (amenorrhea), high values represent worse outcome
Time frame: 3 months after dilatation and curettage
Cumulative adhesion score
The summed score of the adhesion scores of extent of uterine cavity involved, type of adhesion and menstrual pattern; range: 1-12 points, high values represent worse outcome
Time frame: 3 months after dilatation and curettage
Severity
Graded according to cumulative adhesion score: Stage I (mild)(1-4 points), Stage II (moderate)(5-8 points) and Stage III (severe)(9-12 points).
Time frame: 3 months after dilatation and curettage
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2016 to primary completion in Feb 2017, 7 months.
Of 46 interventional studies with no phase under Gynatresia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 77. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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BioRegen Biomedical (CHangzhou) Co., Ltd