InfertilityPhase 1NCT01315470
Use of Granulocyte Colony-stimulating Factor for the Treatment of Recurrent Implantation Failure in IVF Patients
A Phase 1 study testing neupogen administration for women with recurrent IVF failure in people with Infertility, run by Hadassah Medical Organization at 2 sites in Israel.
Trial summary
The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of recurrent implantation failure in IVF patient with cause unknown or due to thin endometrium. Several studies showed that GCSF improves embryo development and implantation and increase pregnancy rate. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- neupogen administration for women with recurrent IVF failure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- Jun 2011to Mar 2013
- Phase
- Phase 1
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women after 5 failures in IVF cycles with cause unknown.
- women after 5 failures in IVF due to thin endometrium (<6 mm) and unresponsive to estrogen supplements.
Who cannot join
- history of hematology disease
- allergy to GCSF
- neutrophilia
- severe lower back pain
- liver dysfunction
- hyperuricemia
- a recent febrile disease or pneumonia
- rheumatoid arthritis 9. sickle cell disease-
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Ein Karem
Jerusalem, Israel
einat zivi, md, zivi_e@hotmail.com
einat zivi, md
Hadassah Ein Karem
Jerusalem
einat zivi, MD, 0508573943, zivi_e@hotmail.com
einat zivi, MD
About this study
Official title: Phase 1 Study of the Use of Granulocyte Colony-stimulating Factor for the Treatment of Repeated Implantation Failure in IVF Patients
The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of recurrent implantation failure in IVF patient with cause unknown or due to thin endometrium. Several studies showed that GCSF improves embryo development and implantation and increase pregnancy rate.
Read the detailed description
The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of repeated implantation failure (5 cycles) in IVF patient with cause unknown or due to thin endometrium. we intend to treat with GCSF during the IVF cycle if thin endometrium (<6 mm) is the cause for the treatment failure, and during the implantation window if cause unknown.
- Conditions
- Infertility
- Being tested
- neupogen administration for women with recurrent IVF failure
- Keywords
- improving pregnancy rate and endometrial thickness
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neupogen administration for women with recurrent IVF failureDrug
Also called GCSF injection, filgrastim
neupogen 300 mcg - twice
| Study group | Role | What they receive |
|---|---|---|
| neupogen | Experimental | Not described Receives: Drug: neupogen administration for women with recurrent IVF failure |
| no intervantion | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
Measured: 18 months
Secondary outcomes (2)
endometrial thickness during IVF treatment
Measured: 18 months
endometrial thickness
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2013 (estimated)
- Study completionMar 2013 (estimated)
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.
- More trials run by Hadassah Medical OrganizationThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- einat zivi, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315470
- Sponsor's protocol ID
- GCSF-HMO-CTIL
- Status last verified
- Mar 2011
- First submitted
- 14 Mar 2011
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Use of Granulocyte Colony-stimulating Factor for the Treatment of Repeated Implantation Failure in IVF Patients
- ClinicalTrials.gov ID
- NCT01315470
- Acronym / sponsor ID
- GCSF-HMO-CTIL
- Conditions
- Infertility
- Keywords
- improving pregnancy rate and endometrial thickness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 15 Mar 2011 (estimated)
- 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 investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of recurrent implantation failure in IVF patient with cause unknown or due to thin endometrium. Several studies showed that GCSF improves embryo development and implantation and increase pregnancy rate.
Detailed description
The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of repeated implantation failure (5 cycles) in IVF patient with cause unknown or due to thin endometrium. we intend to treat with GCSF during the IVF cycle if thin endometrium (<6 mm) is the cause for the treatment failure, and during the implantation window if cause unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neupogen | Experimental | Drug: neupogen administration for women with recurrent IVF failure |
| no intervantion | No intervention | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women after 5 failures in IVF cycles with cause unknown.
- women after 5 failures in IVF due to thin endometrium (<6 mm) and unresponsive to estrogen supplements.
Key exclusion criteria (8 listed)
- history of hematology disease
- allergy to GCSF
- neutrophilia
- severe lower back pain
- liver dysfunction
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 |
|---|---|---|
| neupogen administration for women with recurrent IVF failureAlso: GCSF injection, filgrastimneupogen 300 mcg - twice | Drug | neupogen |
Primary outcome
pregnancy rate
Time frame: 18 months
2 secondary outcomes
endometrial thickness during IVF treatment
Time frame: 18 months
endometrial thickness
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2011.
- 3\. GM-CSF regulation of embryo development and pregnancy. Robertson SA. Cytokine Growth Factor Rev. 2007 Jun-Aug;18(3-4):287-98Link provided by the sponsor.
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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.
einat zivi, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing neupogen administration for women with recurrent IVF failure in people with Infertility, run by Hadassah Medical Organization at 2 sites in Israel.
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 8 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 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 einat zivi, MD (0508573943, zivi_e@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: 18 months). 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 Mar 2011.