The efficacy of COOK balloon placement duration on anti-readhesion in moderate and severe intrauterine adhesions

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100046885

Enrollment

Unknown

Registered

2021-05-29

Start date

2021-06-10

Completion date

Unknown

Last updated

2022-01-10

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

Conditions

Intrauterine adhesion

Interventions

Experimental group:Placing COOK balloon for 8 weeks

Control group:Placing COOK balloon for 4 weeks

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 18-40 years, with childbearing requirements; 2. No hysteroscopy, surgery contraindications; 3. No artificial cycle contraindications (color Doppler ultrasound, normal liver and kidney function); 4. Moderate to severe adhesion (ESGE >= Grade II, AFS>5); 5. Treating patients for the first time; 6. Volunteer to join the study, agree to the treatment plan and postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1. Combined with endocrine abnormalities: hyperthyroidism, ovarian, pituitary, hypothalamic amenorrhea; 2. There are contraindications to the treatment of estrogen and progesterone: patients with malignant endometrial lesions; 3. Deformities of the genital tract; 4. Patients with genital tuberculosis.

Design outcomes

Primary

Measure	Time frame
score of adhesion;re-adhesive rate;PBAC score;thickness of endometrium;	—

Secondary

Measure	Time frame
pregnant rate;time of pregnancy;	—

Countries

China

Contacts

Public ContactZeng Weiwei

Shenzhen Maternity and Child Healthcare Hospital

tyliang2014@126.com+86 15013830120

Outcome results

None listed

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