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

Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft for the Therapy of Uterine Adhesion

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03346317

Enrollment

100

Registered

2017-11-17

Start date

2017-11-16

Completion date

2018-05-20

Last updated

2017-11-20

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

Conditions

Intrauterine Adhesion

Keywords

Asherman syndrome, hysteroscopy, Uterine stent, Estrogen, Amnion, Hysteroscopic Adhesiolysis

Brief summary

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.

Detailed description

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

Interventions

DEVICEdisposable balloon uterine stent

The disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter.

PROCEDUREdried biological amnion graft

Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane

DRUGestradiol valerate tablets+dydrogesterone tablets

oral estradiol valerate tablets+dydrogesterone tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adhesion information	Within the first 3 months after surgery	Intrauterine adhesions under hysteroscopy

Secondary

Measure	Time frame	Description
Menstruation pattern	Within the first 3 months after surgery	menstrual volume which was assessed by pictorial blood loss assessment chart
The change of AFS score	Within the first 3 months after surgery	The American Fertility Society ( AFS ) scoring system (1988 version). Scores of 1-4, 5-8, and 9-12 were mild, moderate, and severe adhesions, respectively.

Countries

China

Contacts

Primary ContactZhu Ru, MD

zhuru19790202@163.com13966636438

Backup ContactWang Sha, MD

wangsha1020@163.com15201556908

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026