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

Intrauterine Adhesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02855632
• Other study ID #: SRRSHRMC2016001
• Status: Recruiting
• Phase: N/A
• First received: April 3, 2016
• Last updated: January 4, 2018
• Start date: August 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: Sir Run Run Shaw Hospital
• Contact: Xiaona Lin, Doctor
• Phone: +8657186006252
• Email: linna73[@]263.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Tissue Adhesions

Intervention

Drug:
• G-CSF
7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing.
• Normal saline
7 days after first hysteroscopic adhesiolysis, normal saline will be injected into the uterine cavity after balloon removing.
• 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.

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital	Ningbo Women and Children's hospital,zhejiang province,China, Wenzhou people's hospital,zhejiang province,China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Endometrial thickness	Endometrial thickness in the ovulation phase after G-CSF injection	1 months after G-CSF injection
Primary	Adhesion reformation rate	Adhesion reformation rate after first adhesiolysis	2 months after first surgery
Secondary	Pregnancy rate	pregnancy rate after adhesiolysis	3 years after first surgery
Secondary	Live birth rate	live birth rate after adhesiolysis	4 years after first surgery