Repeated Embryo Implantation FailurePhase 3NCT02149277
Gcsf Injection in Women With Repeated Implantaiton Failure
A Phase 3 study testing Filgrastim in people with Repeated Embryo Implantation Failure, run by Clinique Ovo at 1 site in Canada.
Trial summary
The purpose of the study is to see the impact of intrauterine injection of recombinant GCSF on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection) protocols as well as in frozen embryo transfer. In addition, following the injection, the level of G-CSF in the bloodstream will be verified. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Repeated Embryo Implantation Failure
- What is being tested?
- Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Dec 2017
- 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 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between the ages of 18 and 37
- Indication of the Antagonist IVF protocol or indication of a substituted frozen embryo transfer
- Subjects with repetitive embryo implantation failure meaning: a history of 3 embryos transferred including frozen embryo without a positive pregnancy test for women 35 years and younger
- Subjects with repetitive embryo implantation failure meaning: a history of 4 embryos transferred including frozen embryo without a positive pregnancy test for women between the ages of 35 and 37.
- Negative repetitive implantation failure work up
Who cannot join
- Renal failure or cardiac failure
- Chronic neutropenia
- Past or present cancer history
- Sickle cell anemia
- Lithium treatment
- Voluntary withdrawal from the study
- Use of concomitant medication: DHEA (dehydroepiandrosterone ), CoQ10 (coenzyme Q10), Growth Hormone and Viagra
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exogenous Recombinant GCSF in Patients With Repeated Implantation Failure - A Randomized Single-blind Trial
The purpose of the study is to see the impact of intrauterine injection of recombinant GCSF on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection) protocols as well as in frozen embryo transfer. In addition, following the injection, the level of G-CSF in the bloodstream will be verified.
Read the detailed description
Recently, scientists have been interested in G-CSF (Granulocyte - Colony Stimulating Factor) and the latter has seen its use grow in reproductive pathology.
G -CSF, a true center pivot, would act concurrently on oocyte quality and endometrial receptivity, improving:
- Immune tolerance
- The self-healing of oocyte chromosome abnormalities
- The adherence of the embryo
The injection of G-CSF molecule has been used in different circumstances. One of its uses, among others, is to help rebuild the immune system in patients undergoing chemotherapy. Some studies have been conducted in patients having embryo implantation problems; they have demonstrated improved rates of pregnancy and childbirth after treatment.
- Conditions
- Repeated Embryo Implantation Failure
- Being tested
- Filgrastim
- Keywords
- Infertility, IVF, Embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimDrug
Also called Neupogen
The fertility specialist will inject the study medication or its placebo on the 6th day of gonadotrophin stimulation for IVF subjects. For the subjects undergoing embryo transfer, the injection will be done once the endometrial lining measure more than 8mm.
| Study group | Role | What they receive |
|---|---|---|
| Filgrastim | Active comparator | Injection Filgrastim 300 ug intravaginally during an IVF cycle or during an embryo transfer Receives: Drug: Filgrastim |
| Sodium Chloride | Placebo comparator | Injection of 1 ml of Sodium Chloride intravaginally during an IVF cycle or during an embryo transfer cycle. Receives: Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of G-CSF
Measure dosage of G-CSF in the bloodstream on the day of oocyte retrieval and measure the implantation rate as well as pregnancy rate following the G-CSF injection
Measured: up to 3 years
Pregnancy and Implantation
Measure the pregnancy and embryo implantation rate post G-CSF injection
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repeated Embryo Implantation FailureStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacques Kadoch, Md, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149277
- Sponsor's protocol ID
- ovo-12-06
- Status last verified
- Apr 2022
- First submitted
- 19 Mar 2014
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exogenous Recombinant GCSF in Patients With Repeated Implantation Failure - A Randomized Single-blind Trial
- ClinicalTrials.gov ID
- NCT02149277
- Acronym / sponsor ID
- ovo-12-06
- Conditions
- Repeated Embryo Implantation Failure
- Keywords
- Infertility, IVF, Embryo transfer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulty
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 May 2014 (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 the study is to see the impact of intrauterine injection of recombinant GCSF on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection) protocols as well as in frozen embryo transfer. In addition, following the injection, the level of G-CSF in the bloodstream will be verified.
Detailed description
Recently, scientists have been interested in G-CSF (Granulocyte - Colony Stimulating Factor) and the latter has seen its use grow in reproductive pathology.
G -CSF, a true center pivot, would act concurrently on oocyte quality and endometrial receptivity, improving:
- Immune tolerance
- The self-healing of oocyte chromosome abnormalities
- The adherence of the embryo
The injection of G-CSF molecule has been used in different circumstances. One of its uses, among others, is to help rebuild the immune system in patients undergoing chemotherapy. Some studies have been conducted in patients having embryo implantation problems; they have demonstrated improved rates of pregnancy and childbirth after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filgrastim | Active comparator | Drug: FilgrastimInjection Filgrastim 300 ug intravaginally during an IVF cycle or during an embryo transfer |
| Sodium Chloride | Placebo comparator | Drug: FilgrastimInjection of 1 ml of Sodium Chloride intravaginally during an IVF cycle or during an embryo transfer cycle. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women between the ages of 18 and 37
- Indication of the Antagonist IVF protocol or indication of a substituted frozen embryo transfer
- Subjects with repetitive embryo implantation failure meaning: a history of 3 embryos transferred including frozen embryo without a positive pregnancy test for women 35 years and younger
- Subjects with repetitive embryo implantation failure meaning: a history of 4 embryos transferred including frozen embryo without a positive pregnancy test for women between the ages of 35 and 37.
- Negative repetitive implantation failure work up
Key exclusion criteria (7 listed)
- Renal failure or cardiac failure
- Chronic neutropenia
- Past or present cancer history
- Sickle cell anemia
- Lithium treatment
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 |
|---|---|---|
| FilgrastimAlso: NeupogenThe fertility specialist will inject the study medication or its placebo on the 6th day of gonadotrophin stimulation for IVF subjects. For the subjects undergoing embryo transfer, the injection will be done once the endometrial lining measure more than 8mm. | Drug | Filgrastim, Sodium Chloride |
Primary outcome
Dosage of G-CSF
Time frame: up to 3 years
Measure dosage of G-CSF in the bloodstream on the day of oocyte retrieval and measure the implantation rate as well as pregnancy rate following the G-CSF injection
Pregnancy and Implantation
Time frame: up to 3 years
Measure the pregnancy and embryo implantation rate post G-CSF injection
Results and safety
The study was stopped early (reason given: Recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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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.
Jacques Kadoch, Md principal investigator
Clinique Ovo
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 Filgrastim in people with Repeated Embryo Implantation Failure, run by Clinique Ovo at 1 site in Canada.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Apr 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 Canada. 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?
The study was stopped early (reason given: Recruitment difficulty). Results are not available in the source record.
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?
Dosage of G-CSF (time frame: up to 3 years). 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 27 Apr 2022.