InfertilityG-CSFNCT03783208
Intrauterine G-CSF Administration in RIF
A study testing G-CSF and Saline in people with Infertility, run by Gurgan Clinic at 1 site in Turkey (Türkiye).
Trial summary
Aim of this study is to investigate the effects of intrauterine G-CSF on endometrial thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure (RIF) group Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- G-CSF and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 20 Dec 2018
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women under the age of 40 who met the RIF definition
- Follicle-stimulating hormone (FSH) levels were <15 IU/mL
Who cannot join
- Patients with congenital uterine anomalies
- Patients with Asherman's syndrome
- Patients with uterine cavity distorted by myoma or endometrial polyps
- Patients with confirmed endometriosis or endometrioma
- Patients for whom G-CSF was contraindicated (active infections, kidney disease, sickle cell anemia, malignancies, chronic neutropenia)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gurgan Clinic IVF and Women Health Center
Ankara, Cankaya, 06640
About this study
Official title: Intrauterine G-CSF Administration in Recurrent Implantation Failure
Aim of this study is to investigate the effects of intrauterine G-CSF on endometrial thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure (RIF) group
Read the detailed description
This study was designed as a prospective randomized controlled trial with the involvement of 200 RIF group patients.The procedure will perform by administering 30 mIU of Leucostim®(Filgrastim [G-CSF] 30mIU/mL; DEM Medical, Dong-A; South Korea) through slow infusion into the endometrial cavity using a soft embryo transfer catheter. Normal saline of 1 mL will be infused into the endometrial cavity in the same way in the control group. The standard ICSI procedure will use for all patients, and fresh cycle embryos will be transferred on the third or fifth day.
- Conditions
- Infertility
- Being tested
- G-CSF, Saline
- Keywords
- Endometrium, G-CSF, Recurrent implantation failure
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSFDrug
Also called Leucostim
Slow infusion of G-CSF into the endometrial cavity using a soft embryo transfer catheter.
SalineOther
Slow infusion of saline into the endometrial cavity using a soft embryo transfer catheter.
| Study group | Role | What they receive |
|---|---|---|
| G-CSF | Experimental | Patients in the G-CSF group will receive G-CSF once a day on hCG day, before hCG injection. The procedure involved the administration of G-CSF through slow infusion into the endometrial cavity using a soft embryo transfer catheter. Receives: Drug: G-CSF |
| Control group | Placebo comparator | Normal saline of 1 mL was infused into the endometrial cavity in the same way in patients in the control group Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Gestational sac in USG per embryo transfer
Measured: 1month
Secondary outcomes (1)
Endometrial thickness
Measurement of endometrial thickness as millimeter
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Nov 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gurgan Clinic
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ziya Kalem, MD, Principal investigator, Gurgan Clinic IVF and Women Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783208
- Sponsor's protocol ID
- 20182
- Acronym
- G-CSF
- Status last verified
- Dec 2018
- First submitted
- 19 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine G-CSF Administration in Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT03783208
- Acronym / sponsor ID
- G-CSF / 20182
- Conditions
- Infertility
- Keywords
- Endometrium, G-CSF, Recurrent implantation failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Gurgan ClinicResearch network
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 20 Dec 2018 (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.
Aim of this study is to investigate the effects of intrauterine G-CSF on endometrial thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure (RIF) group
Detailed description
This study was designed as a prospective randomized controlled trial with the involvement of 200 RIF group patients.The procedure will perform by administering 30 mIU of Leucostim®(Filgrastim [G-CSF] 30mIU/mL; DEM Medical, Dong-A; South Korea) through slow infusion into the endometrial cavity using a soft embryo transfer catheter. Normal saline of 1 mL will be infused into the endometrial cavity in the same way in the control group. The standard ICSI procedure will use for all patients, and fresh cycle embryos will be transferred on the third or fifth day.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF | Experimental | Drug: G-CSFPatients in the G-CSF group will receive G-CSF once a day on hCG day, before hCG injection. The procedure involved the administration of G-CSF through slow infusion into the endometrial cavity using a soft embryo transfer catheter. |
| Control group | Placebo comparator | Other: SalineNormal saline of 1 mL was infused into the endometrial cavity in the same way in patients in the control group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women under the age of 40 who met the RIF definition
- Follicle-stimulating hormone (FSH) levels were <15 IU/mL
Key exclusion criteria (5 listed)
- Patients with congenital uterine anomalies
- Patients with Asherman's syndrome
- Patients with uterine cavity distorted by myoma or endometrial polyps
- Patients with confirmed endometriosis or endometrioma
- Patients for whom G-CSF was contraindicated (active infections, kidney disease, sickle cell anemia, malignancies, chronic neutropenia)
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 |
|---|---|---|
| G-CSFAlso: LeucostimSlow infusion of G-CSF into the endometrial cavity using a soft embryo transfer catheter. | Drug | G-CSF |
| SalineSlow infusion of saline into the endometrial cavity using a soft embryo transfer catheter. | Other | Control group |
Primary outcome
Clinical pregnancy rate
Time frame: 1month
Gestational sac in USG per embryo transfer
1 secondary outcome
Endometrial thickness
Time frame: 1month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
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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.
Ziya Kalem, MD principal investigator
Gurgan Clinic IVF and Women Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-CSF and Saline in people with Infertility, run by Gurgan Clinic at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 24 Dec 2018. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 1month). 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 Dec 2018.