The Effect of the GM-CSF Gel on the Endometrial Thickness in Infertile Women With Thin Endometrium

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of the granulocyte-macrophage colony stimulating factor(GM-CSF) gel on the endometrial thickness in infertile women with thin endometrium.

Detailed Description
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The thin endometrium is detrimental to embryo implantation, probability of clinical pregnancy for an endometrial thickness ≤ 7 mm was significantly lower compared with cases with endometrial thickness > 7 mm. It has been reported the granulocyte colony stimulating factor (G-CSF) increased the endometrial thickness and pregnancy rate of infertile women with thin endometrium during IVF cycle. However, most of the researches were retrospective and small sample size, and the results were conflicted among them. GM-CSF is another member of CSF superfamily, recalling more macrophage than G-CSF, which could be more effective in local homeostasis maintain and wound repair. GM-CSF has been widely used in skin repair after burn. It was also found the GM-CSF and its receptor in endometrium. In the past year, the investigators tried GM-CSF irrigation in 21 women with thin endometrium and most of them received GM-CSF after hysteroscopic examination or slight adhesion relaxing, and the preliminary data suggested that the GM-CSF may promote the endometrial growth. Does the GM-CSF gel can improve the endometrial thickness? Therefore, this study was conducted.

Official Title
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A Randomized Controlled Trial of the Effect of the Granulocyte-macrophage Colony Stimulating Factor Gel on the Endometrial Thickness in Infertile Women With Thin Endometrium

Conditions
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Thin Endometrium

Intervention / Treatment
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* Drug: GM-CSF
* Drug: 17-ß estradiol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman undergoes IVF treatment, 18-40 years old The endometrial thickness <7mm on the day of human chorionic gonadotropin during IVF or after taking oral estradiol valerate 6mg/d for 14 days. Embryo transfer is cancelled because of thin endometrium No intrauterine adhesion according to the 3-D ultrasonography Exclusion Criteria: Systemic diseases unable to conceive Chromasome abnormal History of G-CSF or GM-CSF allergy or untoward effect Thin endometrium related to clomid Severe or moderate uterine adhesion The influence factor of embryo implantation: hydrosalpinx, endometriosis, adenomyosis,myoma of uterus Uterine malformation, adenomyosis, uterine leiomyoma sized more than 2cm. Patients who is allergic to granulocyte-macrophage colony stimulating factor Patients with inflammation of reproductive organs, pelvic cavity inflammation, malignant tumor of reproductive organs and other systemic diseases that could cause metrorrhagia

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GM-CSF<br>Hysteroscopy will be arranged to confirm the uterine cavity is normal and there is no significant intrauterine adhesion. 3ml GM-CSF gel will be irrigated into the uterine cavity immediately when hysteroscopy is complete. Then same dose gel will be given every other day twice. | Drug: GM-CSF<br>* 3ml GM-CSF gel will be irrigated into the uterine cavity immediately when hysteroscopy is complete. Then same dose gel will be given every other day twice<br>* Other names: granulocyte-macrophage colony stimulating factor;Drug: 17-ß estradiol<br>* A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer<br>* Other names: Femoston;|
| Experimental: Control<br>Hysteroscopy will be arranged to confirm the uterine cavity is normal and there is no significant intrauterine adhesion. After hysteroscopy examination, nothing was applied to the uterine cavity. | Drug: 17-ß estradiol<br>* A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer<br>* Other names: Femoston;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the endometrial thickness | the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound | 1 months after hysteroscopy examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| embryo transfer cancelation rate | according to the patients' wishes | 2 months after hysteroscopy examination | 
| uterine artery blood supply markers | uterine artery blood supply markers, such as PI, reflux index(RI) and S/D, evaluated based on the 3-D ultrasonography | 1 months after hysteroscopy examination | 
| pregnancy rate | pregnancy rate after frozen embryo transfer | 3 months after hysteroscopy examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GM-CSF, frozen embryo transfer