Clinical trial NCT04100655: The Effect of the GM-CSF Gel on the Endometrial Thickness in Infertile Women With Thin Endometrium
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thin Endometrium
Keywords: GM-CSF
frozen embryo transfer
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the endometrial thickness
timeFrame: 1 months after hysteroscopy examination
Secondary outcomes:
measure: embryo transfer cancelation rate
timeFrame: 2 months after hysteroscopy examination
measure: uterine artery blood supply markers
timeFrame: 1 months after hysteroscopy examination
measure: pregnancy rate
timeFrame: 3 months after hysteroscopy examination
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Xiaona Lin, Doctor
role: STUDY_DIRECTOR
References: