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

Not Applicable

• Conditions: Thin Endometrium
• Interventions: Drug: 17-ß estradiol; Drug: GM-CSF

• Registration Number: NCT04100655
• Lead Sponsor: Sir Run Run Shaw Hospital

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.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-20
• Last Update Submitted: 2019-09-20
• Study First Posted: 2019-09-24
• Last Update Posted: 2019-09-24
• Study Start: 2019-10
• Primary Completion: 2020-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	17-ß estradiol	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.
GM-CSF	17-ß estradiol	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.
GM-CSF	GM-CSF	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.

Primary Outcome Measures

Name	Time	Method
the endometrial thickness	1 months after hysteroscopy examination	the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound

Secondary Outcome Measures

Name	Time	Method
embryo transfer cancelation rate	2 months after hysteroscopy examination	according to the patients' wishes
pregnancy rate	3 months after hysteroscopy examination	pregnancy rate after frozen embryo transfer
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

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China