The Effect of the GM-CSF Gel on the Endometrial Thickness in Infertile Women With Thin Endometrium
Primary Purpose
Thin Endometrium
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GM-CSF
17-ß estradiol
Sponsored by
About this trial
This is an interventional treatment trial for Thin Endometrium focused on measuring GM-CSF, frozen embryo transfer
Eligibility Criteria
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
Sites / Locations
- Sir Run Run Shaw Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
GM-CSF
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
the endometrial thickness
the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound
Secondary Outcome Measures
embryo transfer cancelation rate
according to the patients' wishes
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
pregnancy rate
pregnancy rate after frozen embryo transfer
Full Information
NCT ID
NCT04100655
First Posted
September 3, 2019
Last Updated
September 20, 2019
Sponsor
Sir Run Run Shaw Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04100655
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Run Run Shaw Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thin Endometrium
Keywords
GM-CSF, frozen embryo transfer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GM-CSF
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GM-CSF
Other Intervention Name(s)
granulocyte-macrophage colony stimulating factor
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
17-ß estradiol
Other Intervention Name(s)
Femoston
Intervention Description
A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer
Primary Outcome Measure Information:
Title
the endometrial thickness
Description
the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound
Time Frame
1 months after hysteroscopy examination
Secondary Outcome Measure Information:
Title
embryo transfer cancelation rate
Description
according to the patients' wishes
Time Frame
2 months after hysteroscopy examination
Title
uterine artery blood supply markers
Description
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
Title
pregnancy rate
Description
pregnancy rate after frozen embryo transfer
Time Frame
3 months after hysteroscopy examination
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaona Lin, Doctor
Phone
+8657186006252
Email
linna73@263.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaona Lin, Doctor
Organizational Affiliation
Sir Run Run Shaw Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minling Wei, Master
Phone
+8657186002222
Email
minling_wei@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of the GM-CSF Gel on the Endometrial Thickness in Infertile Women With Thin Endometrium
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