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

September 20, 2019 updated by: Xiaona Lin, Sir Run Run Shaw Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310018
        • Sir Run Run Shaw Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the endometrial thickness
Time Frame: 1 months after hysteroscopy examination
the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound
1 months after hysteroscopy examination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
embryo transfer cancelation rate
Time Frame: 2 months after hysteroscopy examination
according to the patients' wishes
2 months after hysteroscopy examination
uterine artery blood supply markers
Time Frame: 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
1 months after hysteroscopy examination
pregnancy rate
Time Frame: 3 months after hysteroscopy examination
pregnancy rate after frozen embryo transfer
3 months after hysteroscopy examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sir Run Run Shaw Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SRRSH20190806-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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