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

January 4, 2018 updated by: Xiaona Lin, Sir Run Run Shaw Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310018
        • Recruiting
        • Sir run run shaw Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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: 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.
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% sodium chloride
  • 0.9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adhesion reformation rate
Time Frame: 2 months after first surgery
Adhesion reformation rate after first adhesiolysis
2 months after first surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 3 years after first surgery
pregnancy rate after adhesiolysis
3 years after first surgery
Live birth rate
Time Frame: 4 years after first surgery
live birth rate after adhesiolysis
4 years after first surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial thickness
Time Frame: 1 months after G-CSF injection
Endometrial thickness in the ovulation phase after G-CSF injection
1 months after G-CSF injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Run Run Shaw Hospital

Collaborators

Ningbo Women & Children's Hospital
Wenzhou people's hospital，zhejiang province,China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

April 3, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (ESTIMATE)

August 4, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRRSHRMC2016001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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