Women With Recurrent Implantation Failure in IVFPhase 3NCT01715974
Use of GM-CSF Treatment in Recurrent Implantation Failure
A Phase 3 study testing GM-CSF group in people with Women With Recurrent Implantation Failure in IVF, 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 treatment with GM-CSF, a growth factor working on stem cells, may improve the pregnancy rate and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Women With Recurrent Implantation Failure in IVF
- What is being tested?
- GM-CSF group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 12 Dec 2017to Aug 2022
- Phase
- Phase 3
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women 50 years old or less with three or more previous egg donation cycles failed,
- with a total of at least 4 blastocysts replaced in uterus
Who cannot join
- chromosomal defects in the patients,
- metabolic diseases (diabetes etc.)
- genetic diseases (thalassemia, cystic fibrosis, etc.)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Cerm-Hungaria
Rome, 198
Marco Sbracia, MD, +393479037433, marcandrea@hotmail.com
Fabio Scarpellini, MD, +393278779064, marcandrea@hotmail.com
About this study
Official title: Administration of GM-CSF in Women With Recurrent Implantation Failure in IVF Cycles and Egg Donation Cycles
The purpose of this study is to determine whether in Assisted Reproductive Technologies the treatment with GM-CSF, a growth factor working on stem cells, may improve the pregnancy rate and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles.
Read the detailed description
The GM-CSF is a cytokine promoting leukocyte growth, but also trophoblast development. In this randomized sudy investigators will test this cytokine as a treatment for recurrent implantation failure after IVF, at leat three failed previous IVF attempts.
The study will be conducted in 100 women with recurrent implantation failure of egg donation cycles. The inclusion criteria will be, at least three previous failed Egg Donation attempts where at least 4 good blastocysts were transferred, women less than 50 years old, absence of systemic diseases. These women will undergo egg donation cycle and they will randomly divided in two groups: one (50 women) will be treated with subcutaneous GM-CSF 60 micrograms/day from the day of transfer to the day of β-hCG test, and if it will be positive the treatment will be continued for other 40 days; the group of control will be treated with subcutaneous saline solution infusion in the same way of the study group. Primary outcomes will be considered: pregnancy rate and live birth rate, the of β-hCG levels at 14/21/28 and 35 days after embryo transfer.
- Being tested
- GM-CSF group, CONTROL
- Keywords
- GM-CSF, IVF failure,pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSF groupDrug
Also called GM-CSF
30 micrograms/day of GM-CSF from the day of embryo transfer through the day of beta HCG test
CONTROLDrug
Also called SALINE INFUSION
saline infusion every day from the day of embryo transfer through the day of beta HCG test
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Placebo comparator | patients with recurrent implantation failure treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test Receives: Drug: CONTROL |
| GM-CSF group | Experimental | patients with recurrent implantation failure treated with GM-CSF (30 micrograms/day) from the day of embryo transfer through the day of beta hCG test Receives: Drug: GM-CSF group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy outcome
The number of patients pregnant after treatment with GM-CSF (30 microgram/day)compared with the number of patients pregnant in the control group
Measured: 12 months
Secondary outcomes (1)
implantation rate
number of embryos implanted
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 posted29 Oct 2012 (estimated)
- Study start12 Dec 2017
- Primary completion31 Jul 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Women With Recurrent Implantation Failure in IVFStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Endocrinology and Reproductive Medicine, Italy
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marco Sbracia, MD, Study chair, Centre for Endocrinology and Reproductive Medicine, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715974
- Sponsor's protocol ID
- HC0003
- Status last verified
- Jul 2022
- First submitted
- 2 Mar 2012
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 19617208Scarpellini F, Sbracia M, Marconi D, Fracassi A, Santi K, Desole E. A Randomised Controlled Trial on the Treatment of Recurrent Implantation Failure Women Who Failed Egg Donation Cycles Using Low-Dose GM-CSF. Am J Reprod Immunol. 2025 Sep;94(3):e70162. doi: 10.1111/aji.70162.
PubMed 40965804
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of GM-CSF in Women With Recurrent Implantation Failure in IVF Cycles and Egg Donation Cycles
- ClinicalTrials.gov ID
- NCT01715974
- Acronym / sponsor ID
- HC0003
- Keywords
- GM-CSF, IVF failure,pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Centre for Endocrinology and Reproductive Medicine, ItalyResearch network
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 29 Oct 2012 (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 treatment with GM-CSF, a growth factor working on stem cells, may improve the pregnancy rate and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles.
Detailed description
The GM-CSF is a cytokine promoting leukocyte growth, but also trophoblast development. In this randomized sudy investigators will test this cytokine as a treatment for recurrent implantation failure after IVF, at leat three failed previous IVF attempts.
The study will be conducted in 100 women with recurrent implantation failure of egg donation cycles. The inclusion criteria will be, at least three previous failed Egg Donation attempts where at least 4 good blastocysts were transferred, women less than 50 years old, absence of systemic diseases. These women will undergo egg donation cycle and they will randomly divided in two groups: one (50 women) will be treated with subcutaneous GM-CSF 60 micrograms/day from the day of transfer to the day of β-hCG test, and if it will be positive the treatment will be continued for other 40 days; the group of control will be treated with subcutaneous saline solution infusion in the same way of the study group. Primary outcomes will be considered: pregnancy rate and live birth rate, the of β-hCG levels at 14/21/28 and 35 days after embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Placebo comparator | Drug: CONTROLpatients with recurrent implantation failure treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test |
| GM-CSF group | Experimental | Drug: GM-CSF grouppatients with recurrent implantation failure treated with GM-CSF (30 micrograms/day) from the day of embryo transfer through the day of beta hCG test |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women 50 years old or less with three or more previous egg donation cycles failed,
- with a total of at least 4 blastocysts replaced in uterus
Key exclusion criteria (3 listed)
- chromosomal defects in the patients,
- metabolic diseases (diabetes etc.)
- 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 |
|---|---|---|
| GM-CSF groupAlso: GM-CSF30 micrograms/day of GM-CSF from the day of embryo transfer through the day of beta HCG test | Drug | GM-CSF group |
| CONTROLAlso: SALINE INFUSIONsaline infusion every day from the day of embryo transfer through the day of beta HCG test | Drug | CONTROL |
Primary outcome
pregnancy outcome
Time frame: 12 months
The number of patients pregnant after treatment with GM-CSF (30 microgram/day)compared with the number of patients pregnant in the control group
1 secondary outcome
implantation rate
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 20 Jul 2022.
- Background: 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.
- Derived from this study: PubMed 40965804Scarpellini F, Sbracia M, Marconi D, Fracassi A, Santi K, Desole E. A Randomised Controlled Trial on the Treatment of Recurrent Implantation Failure Women Who Failed Egg Donation Cycles Using Low-Dose GM-CSF. Am J Reprod Immunol. 2025 Sep;94(3):e70162. doi: 10.1111/aji.70162.
Related trials for Women With Recurrent Implantation Failure in IVF
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Experimental Study on the Use of Intrauterine Infusion of Autologous Platelet-rich Plasma (PRGF-IUI) in Patients With Recurrent Implantation Failure and/or Refractory Thin Endometrium
Recurrent Implantation Failure, Endometrial Receptivity Disorders
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.
Marco Sbracia, MD 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 3 study testing GM-CSF group in people with Women With Recurrent Implantation Failure in IVF, 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 2 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 20 Jul 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 outcome (time frame: 12 months). 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 NCT01715974, which also lists 2 linked publications.
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 20 Jul 2022.