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

NCT ID: NCT04100655

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2020-12-31

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.

Conditions

Thin Endometrium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

GM-CSF

Intervention Type: DRUG

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

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

17-ß estradiol

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

17-ß estradiol

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

Intervention Type: DRUG

Other Intervention Names

granulocyte-macrophage colony stimulating factor; Femoston

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaona Lin

Vice Director of gynaecology and obstetrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaona Lin, Doctor

Role: STUDY_DIRECTOR

Sir Run Run Shaw Hospital

Locations

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Xiaona Lin, Doctor

Role: CONTACT

linna73@263.net

+8657186006252

Facility Contacts

Minling Wei, Master

Role: primary

minling_wei@126.com

+8657186002222

Other Identifiers

SRRSH20190806-19

Identifier Type: -

Identifier Source: org_study_id