Thin EndometriumNCT04100655
The Effect of the GM-CSF Gel on the Endometrial Thickness in Infertile Women With Thin Endometrium
A study testing GM-CSF and 17-ß estradiol in people with Thin Endometrium, run by Sir Run Run Shaw Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Thin Endometrium
- What is being tested?
- GM-CSF and 17-ß estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Oct 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310018
Minling Wei, Master, +8657186002222, minling_wei@126.com
About this study
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
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.
Read the 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
- Being tested
- GM-CSF, 17-ß estradiol
- Keywords
- GM-CSF, frozen embryo transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSFDrug
Also called granulocyte-macrophage colony stimulating factor
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 estradiolDrug
Also called Femoston
A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| GM-CSF | Experimental | 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. Receives: Drug: GM-CSF; Drug: 17-ß estradiol |
| Control | Experimental | 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. Receives: Drug: 17-ß estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the endometrial thickness
the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound
Measured: 1 months after hysteroscopy examination
Secondary outcomes (3)
embryo transfer cancelation rate
according to the patients' wishes
Measured: 2 months after hysteroscopy examination
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
Measured: 1 months after hysteroscopy examination
pregnancy rate
pregnancy rate after frozen embryo transfer
Measured: 3 months after hysteroscopy examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin EndometriumStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaona Lin, Sir Run Run Shaw Hospital
- Investigators
- Xiaona Lin, Doctor, Study director, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100655
- Sponsor's protocol ID
- SRRSH20190806-19
- Status last verified
- Sep 2019
- First submitted
- 3 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04100655
- Acronym / sponsor ID
- SRRSH20190806-19
- Conditions
- Thin Endometrium
- Keywords
- GM-CSF, frozen embryo transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GM-CSF | Experimental | Drug: GM-CSF, Drug: 17-ß estradiolHysteroscopy 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. |
| Control | Experimental | Drug: 17-ß estradiolHysteroscopy 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GM-CSFAlso: granulocyte-macrophage colony stimulating factor3ml 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 |
| 17-ß estradiolAlso: FemostonA hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer | Drug | Control, GM-CSF |
Primary outcome
the endometrial thickness
Time frame: 1 months after hysteroscopy examination
the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound
3 secondary outcomes
embryo transfer cancelation rate
Time frame: 2 months after hysteroscopy examination
uterine artery blood supply markers
Time frame: 1 months after hysteroscopy examination
pregnancy rate
Time frame: 3 months after hysteroscopy examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaona Lin, Doctor study director
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GM-CSF and 17-ß estradiol in people with Thin Endometrium, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaona Lin, Doctor (+8657186006252, linna73@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the endometrial thickness (time frame: 1 months after hysteroscopy examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.