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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GM-CSF | Experimental | 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. |
|
| Control | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GM-CSF | Drug | 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaona Lin, Doctor | Contact | +8657186006252 | linna73@263.net |
| Name | Affiliation | Role |
|---|---|---|
| Xiaona Lin, Doctor | Sir Run Run Shaw Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310018 | China |
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| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| C472241 | femoston |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
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| 17-ß estradiol | Drug | A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer |
|
|
| 1 months after hysteroscopy examination |
| pregnancy rate | pregnancy rate after frozen embryo transfer | 3 months after hysteroscopy examination |
| D016207 |
| Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |