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The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis

Zhejiang University logo

Zhejiang University

Status

Unknown

Conditions

Intrauterine Adhesion

Treatments

Drug: Normal saline
Other: Cook balloon
Drug: G-CSF
Drug: hormone therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02855632
SRRSHRMC2016001

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy of Granulocyte Colony Stimulating Factor(G-CSF) on decreasing adhesion reformation and improving fertility outcomes after hysteroscopic adhesiolysis in patients with moderate to severe intrauterine adhesions.

Full description

After hysteroscopic adhesiolysis, patients with moderate to severe intrauterine adhesions will be allocated into 2 groups randomly, with COOK ballon and estrogen and progesterone sequential therapy given to prevent adhesion routinely. 7 day later, G-CSF or normal saline will be injected into the uterine cavity by Tom catheter after removing the balloon respectively. A second hysteroscopic examination will be performed in 2 months to check up the adhesion reformation. In addition, the endometrial thickness after surgery and fertility outcome will be followed up.

Enrollment

240 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Moderate and severe intrauterine adhesion patients(AFS score ≥5)
  • age 18-40
  • first time receiving hysteroscopic adhesiolysis
  • provided COOK balloon as adjuvant adhesion prevention treatment
  • accepting randomized trial

Exclusion criteria

  • Mild adhesion patients
  • uterine shape can't be restored in the end of surgery
  • abnormal chromosome phenotype
  • systemic disease
  • no fertility desire
  • contradiction of G-CSF injection.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

240 participants in 2 patient groups, including a placebo group

G-CSF
Experimental group
Description:
G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
Treatment:
Drug: hormone therapy
Other: Cook balloon
Drug: G-CSF
Normal saline
Placebo Comparator group
Description:
equal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
Treatment:
Drug: hormone therapy
Other: Cook balloon
Drug: Normal saline

Trial contacts and locations

1

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Central trial contact

Xiaona Lin, Doctor

Data sourced from clinicaltrials.gov

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