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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
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
A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
the endometrial thickness
the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound
Time frame: 1 months after hysteroscopy examination
embryo transfer cancelation rate
according to the patients' wishes
Time frame: 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
Time frame: 1 months after hysteroscopy examination
pregnancy rate
pregnancy rate after frozen embryo transfer
Time frame: 3 months after hysteroscopy examination
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