Comparing the Efficacy of Two Methods in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

B

Beijing Obstetrics and Gynecology Hospital

Status

Unknown

Conditions

Intrauterine Adhesion

Treatments

Device: disposable balloon uterine stent
Procedure: dried biological amnion graft
Drug: estradiol valerate tablets+dydrogesterone tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT03346317
No.5-20171111

Details and patient eligibility

About

Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon with amniotic products or estrogen can improve clinical outcomes? Therefore, this study was conducted.

Full description

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention

Enrollment

100 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age 20-40 years;
  • previously diagnostic hysteroscopy confirmed adhesion score >5, according to the American Fertility Society (AFS)classification of IUA;
  • complains of menstruation disorder and reproductive dysfunction;
  • informed consent.

Exclusion criteria

  • premature menopause,
  • presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
  • presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
  • adhesions limited to the lower uterine cavity or the cervical canal.

Trial design

100 participants in 2 patient groups

dried biological amnion graft
Experimental group
Description:
patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis.
Treatment:
Procedure: dried biological amnion graft
Device: disposable balloon uterine stent
estrogen
Experimental group
Description:
patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
Treatment:
Drug: estradiol valerate tablets+dydrogesterone tablets
Device: disposable balloon uterine stent

Trial contacts and locations

0

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Central trial contact

Zhu Ru, MD; Wang Sha, MD

Data sourced from clinicaltrials.gov

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