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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Drug: G-CSF Drug: Normal saline Drug: hormone therapy Other: Cook balloon Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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Arm Intervention/treatment
Experimental: G-CSF
G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
 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: 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Adhesion reformation rate [ Time Frame: 2 months after first surgery ]
    Adhesion reformation rate after first adhesiolysis


Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 3 years after first surgery ]
    pregnancy rate after adhesiolysis

  2. Live birth rate [ Time Frame: 4 years after first surgery ]
    live birth rate after adhesiolysis


Other Outcome Measures:
  1. Endometrial thickness [ Time Frame: 1 months after G-CSF injection ]
    Endometrial thickness in the ovulation phase after G-CSF injection


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855632


Contacts
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Contact: Xiaona Lin, Doctor +8657186006252 linna73@263.net

Locations
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China, Zhejiang
Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China, 310018
Contact: Yamei Xue, Master    +8657186002222    yaya7450@sina.com   
Sponsors and Collaborators
Sir Run Run Shaw Hospital
Wenzhou people's hospital，zhejiang province,China
Ningbo Women and Children's hospital，zhejiang province,China
Investigators
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Study Director: Xiaona Lin, Doctor Sir Run Run Shaw Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xiaona Lin, MD, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT02855632    
Other Study ID Numbers: SRRSHRMC2016001
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Xiaona Lin, Sir Run Run Shaw Hospital:
G-CSF
adhesion reformation
Asherman syndrome
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Hormones
Progesterone
Sargramostim
 Lenograstim
Estrogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins
Immunologic Factors
Adjuvants, Immunologic