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

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

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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