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

NCT02855632 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-01-05

No results posted yet for this study

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.

Conditions

  • Intrauterine Adhesion

Interventions

DRUG

G-CSF

7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing.

DRUG

Normal saline

7 days after first hysteroscopic adhesiolysis, normal saline will be injected into the uterine cavity after balloon removing.

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

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.

Sponsors & Collaborators

  • Wenzhou people's hospital，zhejiang province,China

    collaborator UNKNOWN

  • Ningbo Women & Children's Hospital

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    lead OTHER

Principal Investigators

  • Xiaona Lin, Doctor · Sir Run Run Shaw Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02855632 on ClinicalTrials.gov