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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intrauterine Adhesion

Intervention / Treatment
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* Drug: G-CSF
* Drug: Normal saline
* Drug: hormone therapy
* Other: Cook balloon


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-CSF<br>G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis. | Drug: G-CSF<br>* 7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing.<br>* Other names: granulocyte colony-stimulating factor;Drug: hormone therapy<br>* 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.<br>* Other names: Estrogen and Progesterone Sequential Therapy;Other: Cook balloon<br>* 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.<br>|
| Placebo Comparator: Normal saline<br>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<br>* 7 days after first hysteroscopic adhesiolysis, normal saline will be injected into the uterine cavity after balloon removing.<br>* Other names: 0.9% sodium chloride;Drug: hormone therapy<br>* 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.<br>* Other names: Estrogen and Progesterone Sequential Therapy;Other: Cook balloon<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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G-CSF, adhesion reformation, Asherman syndrome