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

Sponsor

Sir Run Run Shaw Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04100655

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thin Endometrium	Drug: GM-CSF Drug: 17-ß estradiol	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: GM-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 Other Names: granulocyte-macrophage colony stimulating factor Drug: 17-ß estradiol A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer Other Names: Femoston
Experimental: Control 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.	Drug: 17-ß estradiol A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer Other Names: Femoston

Arm

Intervention/Treatment

Experimental: 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.

Drug: GM-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

Other Names:

granulocyte-macrophage colony stimulating factor

Drug: 17-ß estradiol

A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer

Other Names:

Femoston

Experimental: Control

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.

Drug: 17-ß estradiol

A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer

Other Names:

Femoston

Outcome Measures

Primary Outcome Measures

the endometrial thickness [1 months after hysteroscopy examination]
the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Woman undergoes IVF treatment, 18-40 years old
The endometrial thickness <7mm on the day of human chorionic gonadotropin during IVF or after taking oral estradiol valerate 6mg/d for 14 days.
Embryo transfer is cancelled because of thin endometrium
No intrauterine adhesion according to the 3-D ultrasonography

Exclusion Criteria:

Systemic diseases unable to conceive
Chromasome abnormal
History of G-CSF or GM-CSF allergy or untoward effect
Thin endometrium related to clomid
Severe or moderate uterine adhesion
The influence factor of embryo implantation: hydrosalpinx, endometriosis, adenomyosis,myoma of uterus
Uterine malformation, adenomyosis, uterine leiomyoma sized more than 2cm.
Patients who is allergic to granulocyte-macrophage colony stimulating factor
Patients with inflammation of reproductive organs, pelvic cavity inflammation, malignant tumor of reproductive organs and other systemic diseases that could cause metrorrhagia