InfertilityPhase 4NCT02651285
Use of G-CSF Supplemented IVF Medium in Patients Undergoing IVF
A Phase 4 study testing G-CSF medium in people with Infertility and Embryo Development, run by Centre for Endocrinology and Reproductive Medicine, Italy at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether in Assisted Reproductive Technologies the use of culture medium supplemented with G-CSF, a growth factor working on stem cells, may improve the embryo implantation and pregnancy rate in infertile patients undergoing IVF cycles. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Infertility, Embryo Development, IVF
- What is being tested?
- G-CSF medium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Mar 2017
- Phase
- Phase 4
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertility
- healthy condition,
- good ovarian reserve (AMH levels more than 1microg/ml)
Who cannot join
- chromosomal defects in the couple,
- metabolic diseases (diabetes, etc),
- other genetic diseases (thalassemia, cystic fibrosis, etc.)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Cerm-Hungaria
Rome, 00153
MARCO SBRACIA, MD, +393479037433, marcandrea@hotmail.com
FABIO SCARPELLINI, MD, +393278779064, quelidebercia@hotmail.com
About this study
Official title: G-CSF Supplemented Medium for IVF Embryo Culture in Patients Undergoing IVF
The purpose of this study is to determine whether in Assisted Reproductive Technologies the use of culture medium supplemented with G-CSF, a growth factor working on stem cells, may improve the embryo implantation and pregnancy rate in infertile patients undergoing IVF cycles.
Read the detailed description
In Assisted Reproductive Technologies the rate of pregnancy for cycle and the implantation rate remain low nevertheless the improvement in the last years. In particular also in relatively young reproductive age women nevertheless the good embryos produced and transferred pregnancy rate and implantation rate remain low. Recently, it has been showed that culture medium supplemented with G-CSF, may improve the embryo outcomes in IVF. In this trial the investigators will test the potential benefits of this culture medium on embryos of patients undergoing IVF. 180 infertile women undergoing IVF no more than 37 years old will be selected. These patients will be assigned to two arms, one experimental and one other of control by a computer generated sequence. After the oocyte retrieval and fertilization by ICSI procedure, the fertilised oocyte (2PN)will cultured with the G-CSF supplemented culture medium or in normal culture in micro drop of 30microliters under oil until the day of transfer (day five or blastocyst sage embryos). A maximum of two embryos will be transferred. The pregnancy rate, implantation rate and number of blastocyst developped will be the outcomes considered
- Conditions
- Infertility, Embryo Development, IVF
- Being tested
- G-CSF medium, Control
- Keywords
- G-CSF, BLASTOCYST, IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF mediumOther
Also called (granulokine)
incubation of IVF embryos with a specific medium containing G-CSF
ControlOther
incubation of IVF embryos with a medium without G-CSF
| Study group | Role | What they receive |
|---|---|---|
| G-CSF | Experimental | The embryos obtained with IVF in patients included iin this arm will be incubated after fertilization with medium supplemented with G-CSF Receives: Other: G-CSF medium |
| CONTROL | Placebo comparator | The embryos obtained by women undergoing IVF included in this arm will be incubated with a standard medium for IVF, and utilized as control group. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
The number of patients become pregnant after IVF where G-CSF medium is used divided for the number of patients treated
Measured: 12 months
implantation rate
The number of embryos implanted after IVF where G-CSF medium is used divided for the number of embryos transferred
Measured: 12 months
Secondary outcomes (1)
number of blastocyst developped
The number of blastocysts obtained after IVF where G-CSF medium is used divided for the number of fertilized oocytes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (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.
- 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Endocrinology and Reproductive Medicine, Italy
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy
- Investigators
- Francesco Morgia, MS, Study chair, Centre for Endocrinology and Reproductive Medicine, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651285
- Sponsor's protocol ID
- CRH2016/01
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2016
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G-CSF Supplemented Medium for IVF Embryo Culture in Patients Undergoing IVF
- ClinicalTrials.gov ID
- NCT02651285
- Acronym / sponsor ID
- CRH2016/01
- Conditions
- Infertility, Embryo Development, IVF
- Keywords
- G-CSF, BLASTOCYST, IVF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre for Endocrinology and Reproductive Medicine, ItalyResearch network
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 8 Jan 2016 (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 purpose of this study is to determine whether in Assisted Reproductive Technologies the use of culture medium supplemented with G-CSF, a growth factor working on stem cells, may improve the embryo implantation and pregnancy rate in infertile patients undergoing IVF cycles.
Detailed description
In Assisted Reproductive Technologies the rate of pregnancy for cycle and the implantation rate remain low nevertheless the improvement in the last years. In particular also in relatively young reproductive age women nevertheless the good embryos produced and transferred pregnancy rate and implantation rate remain low. Recently, it has been showed that culture medium supplemented with G-CSF, may improve the embryo outcomes in IVF. In this trial the investigators will test the potential benefits of this culture medium on embryos of patients undergoing IVF. 180 infertile women undergoing IVF no more than 37 years old will be selected. These patients will be assigned to two arms, one experimental and one other of control by a computer generated sequence. After the oocyte retrieval and fertilization by ICSI procedure, the fertilised oocyte (2PN)will cultured with the G-CSF supplemented culture medium or in normal culture in micro drop of 30microliters under oil until the day of transfer (day five or blastocyst sage embryos). A maximum of two embryos will be transferred. The pregnancy rate, implantation rate and number of blastocyst developped will be the outcomes considered
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF | Experimental | Other: G-CSF mediumThe embryos obtained with IVF in patients included iin this arm will be incubated after fertilization with medium supplemented with G-CSF |
| CONTROL | Placebo comparator | Other: ControlThe embryos obtained by women undergoing IVF included in this arm will be incubated with a standard medium for IVF, and utilized as control group. |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- infertility
- healthy condition,
- good ovarian reserve (AMH levels more than 1microg/ml)
Key exclusion criteria (3 listed)
- chromosomal defects in the couple,
- metabolic diseases (diabetes, etc),
- other genetic diseases (thalassemia, cystic fibrosis, etc.)
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-CSF mediumAlso: (granulokine)incubation of IVF embryos with a specific medium containing G-CSF | Other | G-CSF |
| Controlincubation of IVF embryos with a medium without G-CSF | Other | CONTROL |
Primary outcome
pregnancy rate
Time frame: 12 months
The number of patients become pregnant after IVF where G-CSF medium is used divided for the number of patients treated
implantation rate
Time frame: 12 months
The number of embryos implanted after IVF where G-CSF medium is used divided for the number of embryos transferred
1 secondary outcome
number of blastocyst developped
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Individual participant dataSharing planned: Yes
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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.
Francesco Morgia, MS study chair
Centre for Endocrinology and Reproductive Medicine, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing G-CSF medium in people with Infertility and Embryo Development, run by Centre for Endocrinology and Reproductive Medicine, Italy at 1 site in Italy.
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 3 inclusion and 3 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 8 Jan 2016. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Marco Sbracia, MD (+393479037433, marcandrea@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: 12 months). The study lists 2 primary outcomes in all. 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 8 Jan 2016.