search
Back to results

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

Primary Purpose

Intrauterine Adhesion

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
G-CSF
Normal saline
hormone therapy
Cook balloon
Sponsored by
Sir Run Run Shaw Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrauterine Adhesion focused on measuring G-CSF, adhesion reformation, Asherman syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Sir Run Run Shaw HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

G-CSF

Normal saline

Arm Description

G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.

equal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.

Outcomes

Primary Outcome Measures

Adhesion reformation rate
Adhesion reformation rate after first adhesiolysis

Secondary Outcome Measures

Pregnancy rate
pregnancy rate after adhesiolysis
Live birth rate
live birth rate after adhesiolysis

Full Information

First Posted
April 3, 2016
Last Updated
January 4, 2018
Sponsor
Sir Run Run Shaw Hospital
Collaborators
Wenzhou people's hospital，zhejiang province,China, Ningbo Women & Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02855632
Brief Title
The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis
Official Title
The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Run Run Shaw Hospital
Collaborators
Wenzhou people's hospital，zhejiang province,China, Ningbo Women & Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion
Keywords
G-CSF, adhesion reformation, Asherman syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
G-CSF
Arm Type
Experimental
Arm Description
G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
equal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
Intervention Type
Drug
Intervention Name(s)
G-CSF
Other Intervention Name(s)
granulocyte colony-stimulating factor
Intervention Description
7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
0.9% NaCl, 0.9% sodium chloride
Intervention Description
7 days after first hysteroscopic adhesiolysis, normal saline will be injected into the uterine cavity after balloon removing.
Intervention Type
Drug
Intervention Name(s)
hormone therapy
Other Intervention Name(s)
Artificial cycle, Artificial menstrual cycle, Estrogen and Progesterone Sequential Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cook balloon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adhesion reformation rate
Description
Adhesion reformation rate after first adhesiolysis
Time Frame
2 months after first surgery
Secondary Outcome Measure Information:
Title
Pregnancy rate
Description
pregnancy rate after adhesiolysis
Time Frame
3 years after first surgery
Title
Live birth rate
Description
live birth rate after adhesiolysis
Time Frame
4 years after first surgery
Other Pre-specified Outcome Measures:
Title
Endometrial thickness
Description
Endometrial thickness in the ovulation phase after G-CSF injection
Time Frame
1 months after G-CSF injection

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaona Lin, Doctor
Phone
+8657186006252
Email
linna73@263.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaona Lin, Doctor
Organizational Affiliation
Sir Run Run Shaw Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamei Xue, Master
Phone
+8657186002222
Email
yaya7450@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35147195
Citation
Zhang Y, Chen X, Chen S, Wei C, Li B, Wang Z, Shen X, Lin X. Intrauterine administration of G-CSF for promoting endometrial growth after hysteroscopic adhesiolysis: a randomized controlled trial. Hum Reprod. 2022 Apr 1;37(4):725-733. doi: 10.1093/humrep/deac023.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs