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

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ClinicalTrials.gov Identifier: NCT02855632
Recruitment Status : Unknown
Verified January 2018 by Xiaona Lin, Sir Run Run Shaw Hospital.
Recruitment status was:  Recruiting
First Posted : August 4, 2016
Last Update Posted : January 5, 2018
Sponsor:
Collaborators:
Wenzhou people's hospital,zhejiang province,China
Ningbo Women and Children's hospital,zhejiang province,China
Information provided by (Responsible Party):
Xiaona Lin, Sir Run Run Shaw Hospital

Tracking Information
First Submitted Date  ICMJE April 3, 2016
First Posted Date  ICMJE August 4, 2016
Last Update Posted Date January 5, 2018
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
Adhesion reformation rate [ Time Frame: 2 months after first surgery ]
Adhesion reformation rate after first adhesiolysis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
  • Pregnancy rate [ Time Frame: 3 years after first surgery ]
    pregnancy rate after adhesiolysis
  • Live birth rate [ Time Frame: 4 years after first surgery ]
    live birth rate after adhesiolysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 1, 2016)
Endometrial thickness [ Time Frame: 1 months after G-CSF injection ]
Endometrial thickness in the ovulation phase after G-CSF injection
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis
Official Title  ICMJE The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Intrauterine Adhesion
Intervention  ICMJE
  • Drug: G-CSF
    7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing.
    Other Name: granulocyte colony-stimulating factor
  • Drug: Normal saline
    7 days after first hysteroscopic adhesiolysis, normal saline will be injected into the uterine cavity after balloon removing.
    Other Names:
    • 0.9% NaCl
    • 0.9% sodium chloride
  • 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 Names:
    • Artificial cycle
    • Artificial menstrual cycle
    • Estrogen and Progesterone Sequential Therapy
  • 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.
Study Arms  ICMJE
  • Experimental: G-CSF
    G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
    Interventions:
    • Drug: G-CSF
    • Drug: hormone therapy
    • Other: Cook balloon
  • Placebo Comparator: 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.
    Interventions:
    • Drug: Normal saline
    • Drug: hormone therapy
    • Other: Cook balloon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 1, 2016)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02855632
Other Study ID Numbers  ICMJE SRRSHRMC2016001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Xiaona Lin, Sir Run Run Shaw Hospital
Study Sponsor  ICMJE Sir Run Run Shaw Hospital
Collaborators  ICMJE
  • Wenzhou people's hospital,zhejiang province,China
  • Ningbo Women and Children's hospital,zhejiang province,China
Investigators  ICMJE
Study Director: Xiaona Lin, Doctor Sir Run Run Shaw Hospital
PRS Account Sir Run Run Shaw Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP