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A randomized controlled clinical study: collagen scaffold to prevent recurrence after transcervical resection of adhesion for mild-to-morderate intrauterine adhesions

A randomized controlled clinical study: collagen scaffold to prevent recurrence after transcervical resection of adhesion for mild-to-morderate intrauterine adhesions

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17012932
Enrollment
Unknown
Registered
2017-10-10
Start date
2017-10-01
Completion date
Unknown
Last updated
2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intrauterine adhesion

Interventions

Study group:collagen scaffold
Control group: inertia ring

Sponsors

The Affiliated Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) If the patient has frozen embryos, aged 20 to 45 years old; If the patient has no frozen embryos, aged 20 to 38 years old; 2) BMI < 30 kg/m2; 3) Hysteroscopy examination diagnosed Ashermen syndrome have amenorrhoea, the quantity is little, at least one symptom of infertility, and hysteroscopy or histologic diagnosis caused by intrauterine adhesions, accord with the standard of classification of the AFS1988 years class I or class II (grade 3 ~ 8 points); 4) Meet the WHO standards to the diagnosis of infertility; 5) Normal ovarian function; 6) Abortion or curettage surgery before operation, for the first time in at least one year, the menstrual cycle, the volume is normal; 7) Has a clear fertility intentions; 8) Negatie urine pregnancy test; 9) Agree to follow the research process and regular follow-up, signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Have not resolved by IVF infertility etiology, such as the genetic abnormality; 2) Hysteroscopy examination reealed barrel uterine cavity; 3) Simple endometrial thin, no caused by intrauterine adhesions. 4) Caused by intrauterine adhesions separation after simple endometrial scars; 5) Conception taboo disease;Influence uterine muscle intramural uterine fibroids or in the form of greater than 1 cm in diameter polyp;Stage III or IV endometriosis and uterine glandular myopathy. 6) History of malignancy, 7) Congenital malformation uterus and accessories and related operation history; 8) Coagulant function, liver and kidney dysfunction, or other researchers think that may affect the basis of research on diseases (uncontrolled hypertension, diabetes, sexually transmitted diseases, etc.); 9) Has been involved in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Recurrence of intrauterine adhesion;Endometrial thickness and blood flow;

Secondary

MeasureTime frame
Clinical pregnancy rate;Abortion rate;

Countries

China

Contacts

Public ContactYli Hu

The Affiliated Drum Tower Hospital of Nanjing University Medical School

glyyhuyali@163.com+86 13951846008

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026