The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis

B

Beijing Obstetrics and Gynecology Hospital

Status

Unknown

Conditions

Intrauterine Adhesion

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03351205
No.6-20171120

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. Intrauterine balloon has been used for the prevention of intrauterine adhesions. It has been reported that dried biological amnion 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. Disposable balloon uterine stent,which is an innovative intrauterine balloon,is specially designed to fit into the cavity of the uterus. Does Disposable balloon uterine stent and amniotic products combine estrogen therapy 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

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

Trial contacts and locations

0

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Central trial contact

Wang Sha, MD; Zhu Ru, MD

Data sourced from clinicaltrials.gov

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