NCT02855632

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intrauterine Adhesion

Interventions

Type	Name	Description
DRUG	G-CSF	7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing.
DRUG	Normal saline	7 days after first hysteroscopic adhesiolysis, normal saline will be injected into the uterine cavity after balloon removing.
DRUG	hormone therapy	In all cases hormone therapy was commenced shortly after the operation, consisting of oestradiol valerate at a dose of 6 mg per day for 21-28 days with the addition of medroxyprogesterone acetate at a dose of 6 mg per day for the last 7-10 days of the oestrogen therapy. Following the withdrawal bleed, the hormone therapy was repeated for another cycle.
OTHER	Cook balloon	At the end of the procedure, the Cook balloon were placed in the uterine cavity of each patient.the device was removed after 7 days.

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2016-08-04
• Last updated: 2018-01-05

Locations

1 site across 1 country: China