Thin Endometrium
Conditions
Keywords
GM-CSF, frozen embryo transfer
Brief summary
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
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.
Interventions
DRUGGM-CSF
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
DRUG17-ß estradiol
A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Woman undergoes IVF treatment, 18-40 years old 2. The endometrial thickness \<7mm on the day of human chorionic gonadotropin during IVF or after taking oral estradiol valerate 6mg/d for 14 days. 3. Embryo transfer is cancelled because of thin endometrium 4. No intrauterine adhesion according to the 3-D ultrasonography
Exclusion criteria
1. Systemic diseases unable to conceive 2. Chromasome abnormal 3. History of G-CSF or GM-CSF allergy or untoward effect 4. Thin endometrium related to clomid 5. Severe or moderate uterine adhesion 6. The influence factor of embryo implantation: hydrosalpinx, endometriosis, adenomyosis,myoma of uterus 7. Uterine malformation, adenomyosis, uterine leiomyoma sized more than 2cm. 8. Patients who is allergic to granulocyte-macrophage colony stimulating factor 9. Patients with inflammation of reproductive organs, pelvic cavity inflammation, malignant tumor of reproductive organs and other systemic diseases that could cause metrorrhagia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the endometrial thickness | 1 months after hysteroscopy examination | the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| embryo transfer cancelation rate | 2 months after hysteroscopy examination | according to the patients' wishes |
| uterine artery blood supply markers | 1 months after hysteroscopy examination | uterine artery blood supply markers, such as PI, reflux index(RI) and S/D, evaluated based on the 3-D ultrasonography |
| pregnancy rate | 3 months after hysteroscopy examination | pregnancy rate after frozen embryo transfer |
Countries
China
Contacts
Primary ContactXiaona Lin, Doctor
Outcome results
None listed