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

Thin Endometrium Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04100655
• Other study ID #: SRRSH20190806-19
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2019
• Est. completion date: December 2020

Study information

• Verified date: September 2019
• Source: Sir Run Run Shaw Hospital
• Contact: Xiaona Lin, Doctor
• Phone: +8657186006252
• Email: linna73[@]263.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Thin Endometrium

Intervention

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

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the endometrial thickness	the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound	1 months after hysteroscopy examination
Secondary	embryo transfer cancelation rate	according to the patients' wishes	2 months after hysteroscopy examination
Secondary	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	1 months after hysteroscopy examination
Secondary	pregnancy rate	pregnancy rate after frozen embryo transfer	3 months after hysteroscopy examination