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

Not Applicable

• Conditions: Intrauterine Adhesion
• Interventions: Drug: Normal saline; Drug: G-CSF; Drug: hormone therapy; Other: Cook balloon

• Registration Number: NCT02855632
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-04-03
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-05
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	equal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
G-CSF	Cook balloon	G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
Normal saline	Cook balloon	equal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
G-CSF	hormone therapy	G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
Normal saline	hormone therapy	equal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
G-CSF	G-CSF	G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.

Primary Outcome Measures

Name	Time	Method
Adhesion reformation rate	2 months after first surgery	Adhesion reformation rate after first adhesiolysis

Secondary Outcome Measures

Name	Time	Method
Live birth rate	4 years after first surgery	live birth rate after adhesiolysis
Pregnancy rate	3 years after first surgery	pregnancy rate after adhesiolysis

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China