InfertilityPhase 4RIFNCT02250768
Effects of Embryogen in RIF Patients
A Phase 4 study testing GM-CSF in people with Infertility, run by Vietnam National University at 2 sites in Vietnam.
Trial summary
The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with repeated implantation failure (RIF) Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- GM-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesVietnam
- Study dates
- Jul 2013to Aug 2014
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal ovarian reserve (AMH > 1.1 ng/ml)
- Regular menstrual cycle (25 - 34 days)
- Clear informations about at least 3 latest IVF/ET
- Fresh embryo transfer in this cycle
- Endometrial thickness of 10 mm or more
Who cannot join
- Undergo oocyte donation or in vitro maturation (IVM) cycles
- Using frozen or surgically retrieved sperm
- Adenomyosis, Uterine anomaly, uterine fibroid, hydrosalpinges
- In participation in other studies/interventions
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
An Sinh Hospital
Ho Chi Minh City, Ho Chi Minh
An Sinh Hospital
Ho Chi Minh City
About this study
Official title: Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure
The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with repeated implantation failure (RIF)
Read the detailed description
60 patients with repeated implantation failure were involved.
RIF was defined as patients failed to conceive (beta-hCG < 5 mIU/mL) after at least 03 embryo transfers (fresh and frozen) with 06 top quality embryos or more.
Ovarian stimulation was performed using GnRH antagonist protocol. All matured oocytes were inseminated by ICSI. Injected oocytes were cultured in medium supplemented with 2ng/ml of GM-CSF (Embryogen, Origio) until day of transfer. Embryo evaluation was performed at fixed time points of 18 and 44 hour after fertilization. Embryo transfer was performed 2 days after ovum retrieval.
Luteal-phase support was provided using progesterone gel (Crinone 8% 90 mg, twice a day; Merck Serono) and estradiol per os (Valiera 2mg, twice a day; Laboratorios Recalcine). Serum hCG was measured 16 days after oocyte retrieval, and if positive, an ultrasound scan was performed at gestational weeks 7 and 12.
- Conditions
- Infertility
- Being tested
- GM-CSF
- Keywords
- GM-CSF, repeated implantation failure
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSFBiological
2ng/ml of GM-CSF supplemented into culture media
| Study group | Role | What they receive |
|---|---|---|
| GM-CSF | Experimental | Injected oocytes were cultured in GM-CSF supplemented media until day of transfer Receives: Biological: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy rate
Measured: 12 week of gestation
Secondary outcomes (3)
Implantation rate
Measured: 7 week of gestation
clinical pregnancy rate
Measured: 7 week of gestation
top quality embryo rate
Measured: 44 hours after insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionAug 2014
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietnam National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dang Quang Vinh, Vietnam National University
- Investigators
- Vinh Q Dang, Dr, Principal investigator, Research Center for Genetics and Reproductive Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250768
- Sponsor's protocol ID
- CGRH-Embryogen
- Acronym
- RIF
- Status last verified
- Sep 2014
- First submitted
- 23 Sep 2014
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure
- ClinicalTrials.gov ID
- NCT02250768
- Acronym / sponsor ID
- RIF / CGRH-Embryogen
- Conditions
- Infertility
- Keywords
- GM-CSF, repeated implantation failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vietnam National UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Sep 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 this study was to investigate the potential effects of Granulocyte-Macrophage Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with repeated implantation failure (RIF)
Detailed description
60 patients with repeated implantation failure were involved.
RIF was defined as patients failed to conceive (beta-hCG < 5 mIU/mL) after at least 03 embryo transfers (fresh and frozen) with 06 top quality embryos or more.
Ovarian stimulation was performed using GnRH antagonist protocol. All matured oocytes were inseminated by ICSI. Injected oocytes were cultured in medium supplemented with 2ng/ml of GM-CSF (Embryogen, Origio) until day of transfer. Embryo evaluation was performed at fixed time points of 18 and 44 hour after fertilization. Embryo transfer was performed 2 days after ovum retrieval.
Luteal-phase support was provided using progesterone gel (Crinone 8% 90 mg, twice a day; Merck Serono) and estradiol per os (Valiera 2mg, twice a day; Laboratorios Recalcine). Serum hCG was measured 16 days after oocyte retrieval, and if positive, an ultrasound scan was performed at gestational weeks 7 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GM-CSF | Experimental | Biological: GM-CSFInjected oocytes were cultured in GM-CSF supplemented media until day of transfer |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Normal ovarian reserve (AMH > 1.1 ng/ml)
- Regular menstrual cycle (25 - 34 days)
- Clear informations about at least 3 latest IVF/ET
- Fresh embryo transfer in this cycle
- Endometrial thickness of 10 mm or more
Key exclusion criteria (4 listed)
- Undergo oocyte donation or in vitro maturation (IVM) cycles
- Using frozen or surgically retrieved sperm
- Adenomyosis, Uterine anomaly, uterine fibroid, hydrosalpinges
- In participation in other studies/interventions
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-CSF2ng/ml of GM-CSF supplemented into culture media | Biological | GM-CSF |
Primary outcome
ongoing pregnancy rate
Time frame: 12 week of gestation
3 secondary outcomes
Implantation rate
Time frame: 7 week of gestation
clinical pregnancy rate
Time frame: 7 week of gestation
top quality embryo rate
Time frame: 44 hours after insemination
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 26 Sep 2014.
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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.
Vinh Q Dang, Dr principal investigator
Research Center for Genetics and Reproductive Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GM-CSF in people with Infertility, run by Vietnam National University at 2 sites in Vietnam.
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 4 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 26 Sep 2014. 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 Vietnam. 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 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?
ongoing pregnancy rate (time frame: 12 week of gestation). 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 26 Sep 2014.