Habitual AbortionPhase 4NCT00772122
Use of G-CSF for the Treatment of Unexplained Recurrent Miscarriage
A Phase 4 study testing G-CSF and saline solution in people with Habitual Abortion, run by University of Florence at 1 site in Italy.
Trial summary
In order to investigate the effectiveness of G-CSF in preventing embryo demise, the investigators administered this cytokine to women with recurrent miscarriage in a randomized controlled study compared to women treated with placebo. Read more about this study
- Who is it for?
- Ages 25 to 39 years, women only
- Conditions the study is for
- Habitual Abortion
- What is being tested?
- G-CSF and saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2000to Jan 2007
- 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 25 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- four or more previous consecutive abortion,
- failed previous treatment with intravenous immunoglobulins
- negative to all clinical investigation for recurrent miscarriage
Who cannot join
- in the last abortion a fetal karyotype showing chromosomal abnormality
- previous successful pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Trial in Women With Recurrent Miscarriage of G-CSF Versus Placebo
In order to investigate the effectiveness of G-CSF in preventing embryo demise, the investigators administered this cytokine to women with recurrent miscarriage in a randomized controlled study compared to women treated with placebo. Sixty eight women with unexplained primary recurrent miscarriage, all of them with at least four consecutive abortions and negative for all clinical investigations were selected for this study. Patients were randomly treated with G-CSF, starting on the 6th day after ovulation, or with placebo.
Read the detailed description
The patients with unexplained primary (no previous successful pregnancy) recurrent miscarriage (RM) referred to the Hungaria Center for Endocrinology and Reproductive Medicine between January 2000 to January 2007 were considered eligible for the study. The patients had to fulfil the following inclusion criteria: woman's age less than 39 years, more than 4 previous abortions, failure of a previous treatment for RM (immunoglobulin infusion), and they had to be negative for the all the known causes of RM The study was reviewed and approved by the Institutional Review Board, and the clinical study was conducted according to Italian law and the Declaration of Helsinki for Medical Research involving Human Subjects. A sample size calculation showed that a total of 32 patient per group were needed in order to have a difference of 33% between the two groups a for p<0.005 and a beta>0.80 A total of 72 patients were considered eligible for the study, and 68 of them agreed to participate, signing an informed consent form. All the patients were informed about the eventual potential risks of this treatment for the mother and the foetus, other than the lack of information about the developmental toxicity of G-CSF. The patients were randomized by means of a computer generated randomization number sequence. All the patients were informed about the therapy and they gave their written informed consent. They were randomly assigned to the two arms of the study, one to G-CSF treatment and the other to placebo administration; the patients were blind to which treatment they were assigned to. The G-CSF group of 35 women, underwent a daily sub-cutaneous administration of the filgrastim (Neupogen, Dompe', Italy), the recombinant G-CSF, at a dosage of 1 microgram (100000 IU)/kg/day from the 6th day after ovulation till the occurrence of menstruation or to the end of the 9th week of gestation. The placebo group consisting of 33 subjects, was given a treatment with subcutaneous saline solution at the dosage of 0.2 ml daily, and also in this case, from the 6th day after the ovulation till to the recurrence of menstrual loss or to the end of the 9th week. Primary outcome was considered the pregnancy outcome.
- Conditions
- Habitual Abortion
- Being tested
- G-CSF, saline solution
- Keywords
- Recurrent Miscarriage, G-CSF, pregnancy outcome, pregnancy outcome of pregnancies treated with G-CSF, treatment of recurrent miscarriage
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSFDrug
Also called filgrastim (Neupogen, Dompe', Italy),
daily sub-cutaneous administration of the recombinant G-CSF, at a dosage of 1 microgram (100000 IU)/kg/day from the 6th day after ovulation till the occurrence of menstruation or to the end of the 9th week of gestation.
saline solutionDrug
daily sub-cutaneous administration of saline solution 0.2ml from the 6th day after the ovulation till to the recurrence of menstrual loss or to the end of the 9th week.
| Study group | Role | What they receive |
|---|---|---|
| Granulocyte colony stimulating factor | Experimental | The G-CSF group of 35 women, underwent a daily sub-cutaneous administration of the filgrastim (Neupogen, Dompe', Italy), the recombinant G-CSF, at a dosage of 1 micro gram (100000 IU)/kg/day from the 6th day after ovulation till the occurrence of menstruation or to the end of the 9th week of gestation. Receives: Drug: G-CSF |
| placebo (saline solution) | Placebo comparator | The placebo group consisting of 33 subjects, was given a treatment with saline solution at the 0.2ml/day subcutaneously/, from the 6th day after the ovulation till to the recurrence of menstrual loss or to the end of the 9th week. Receives: Drug: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy outcome
Measured: During the treatment
Secondary outcomes (1)
Pregnancy complication, undesired effects
Measured: during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startJan 2000
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Habitual AbortionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Investigators
- Fabio Scarpellini, MD, Principal investigator, Centre for Endocrinology and Reproductive Medicine, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772122
- Sponsor's protocol ID
- CERM0103
- Status last verified
- Oct 2008
- First submitted
- 10 Oct 2008
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scarpellini F, Sbracia M. Use of granulocyte colony-stimulating factor for the treatment of unexplained recurrent miscarriage: a randomised controlled trial. Hum Reprod. 2009 Nov;24(11):2703-8. doi: 10.1093/humrep/dep240. Epub 2009 Jul 17.
PubMed 19617208
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial in Women With Recurrent Miscarriage of G-CSF Versus Placebo
- ClinicalTrials.gov ID
- NCT00772122
- Acronym / sponsor ID
- CERM0103
- Conditions
- Habitual Abortion
- Keywords
- Recurrent Miscarriage, G-CSF, pregnancy outcome, pregnancy outcome of pregnancies treated with G-CSF, treatment of recurrent miscarriage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 15 Oct 2008 (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.
In order to investigate the effectiveness of G-CSF in preventing embryo demise, the investigators administered this cytokine to women with recurrent miscarriage in a randomized controlled study compared to women treated with placebo. Sixty eight women with unexplained primary recurrent miscarriage, all of them with at least four consecutive abortions and negative for all clinical investigations were selected for this study. Patients were randomly treated with G-CSF, starting on the 6th day after ovulation, or with placebo.
Detailed description
The patients with unexplained primary (no previous successful pregnancy) recurrent miscarriage (RM) referred to the Hungaria Center for Endocrinology and Reproductive Medicine between January 2000 to January 2007 were considered eligible for the study. The patients had to fulfil the following inclusion criteria: woman's age less than 39 years, more than 4 previous abortions, failure of a previous treatment for RM (immunoglobulin infusion), and they had to be negative for the all the known causes of RM The study was reviewed and approved by the Institutional Review Board, and the clinical study was conducted according to Italian law and the Declaration of Helsinki for Medical Research involving Human Subjects. A sample size calculation showed that a total of 32 patient per group were needed in order to have a difference of 33% between the two groups a for p<0.005 and a beta>0.80 A total of 72 patients were considered eligible for the study, and 68 of them agreed to participate, signing an informed consent form. All the patients were informed about the eventual potential risks of this treatment for the mother and the foetus, other than the lack of information about the developmental toxicity of G-CSF. The patients were randomized by means of a computer generated randomization number sequence. All the patients were informed about the therapy and they gave their written informed consent. They were randomly assigned to the two arms of the study, one to G-CSF treatment and the other to placebo administration; the patients were blind to which treatment they were assigned to. The G-CSF group of 35 women, underwent a daily sub-cutaneous administration of the filgrastim (Neupogen, Dompe', Italy), the recombinant G-CSF, at a dosage of 1 microgram (100000 IU)/kg/day from the 6th day after ovulation till the occurrence of menstruation or to the end of the 9th week of gestation. The placebo group consisting of 33 subjects, was given a treatment with subcutaneous saline solution at the dosage of 0.2 ml daily, and also in this case, from the 6th day after the ovulation till to the recurrence of menstrual loss or to the end of the 9th week. Primary outcome was considered the pregnancy outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Granulocyte colony stimulating factor | Experimental | Drug: G-CSFThe G-CSF group of 35 women, underwent a daily sub-cutaneous administration of the filgrastim (Neupogen, Dompe', Italy), the recombinant G-CSF, at a dosage of 1 micro gram (100000 IU)/kg/day from the 6th day after ovulation till the occurrence of menstruation or to the end of the 9th week of gestation. |
| placebo (saline solution) | Placebo comparator | Drug: saline solutionThe placebo group consisting of 33 subjects, was given a treatment with saline solution at the 0.2ml/day subcutaneously/, from the 6th day after the ovulation till to the recurrence of menstrual loss or to the end of the 9th week. |
Who may qualify
- Ages
- 25 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- four or more previous consecutive abortion,
- failed previous treatment with intravenous immunoglobulins
- negative to all clinical investigation for recurrent miscarriage
Key exclusion criteria (2 listed)
- in the last abortion a fetal karyotype showing chromosomal abnormality
- previous successful pregnancy
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: filgrastim (Neupogen, Dompe', Italy),daily sub-cutaneous administration of the recombinant G-CSF, at a dosage of 1 microgram (100000 IU)/kg/day from the 6th day after ovulation till the occurrence of menstruation or to the end of the 9th week of gestation. | Drug | Granulocyte colony stimulating factor |
| saline solutiondaily sub-cutaneous administration of saline solution 0.2ml from the 6th day after the ovulation till to the recurrence of menstrual loss or to the end of the 9th week. | Drug | placebo (saline solution) |
Primary outcome
Pregnancy outcome
Time frame: During the treatment
1 secondary outcome
Pregnancy complication, undesired effects
Time frame: during treatment
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 15 Oct 2008.
- Derived from this study: PubMed 19617208Scarpellini F, Sbracia M. Use of granulocyte colony-stimulating factor for the treatment of unexplained recurrent miscarriage: a randomised controlled trial. Hum Reprod. 2009 Nov;24(11):2703-8. doi: 10.1093/humrep/dep240. Epub 2009 Jul 17.
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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.
Fabio Scarpellini, MD principal investigator
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 and saline solution in people with Habitual Abortion, run by University of Florence 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 2 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 15 Oct 2008. 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?
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?
Pregnancy outcome (time frame: During the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00772122, which also lists 1 linked publication.
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 15 Oct 2008.