Embryo's Genetic and Chromosomal QualityPhase 3NCT01636505
The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation Protocol
A Phase 3 study testing ghrh antagonist (cetrotide/orgalutran) and gnrh agonist (suprefact) in people with Embryo's Genetic and Chromosomal Quality, run by European Hospital at 1 site in Italy.
Trial summary
The aim of this study is to performed a randomized controlled trial to evaluate the rate of genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocols. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Embryo's Genetic and Chromosomal Quality
- What is being tested?
- ghrh antagonist (cetrotide/orgalutran) and gnrh agonist (suprefact)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2012to Sep 2013
- 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 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients carrier genetic disease
- advanced maternal Age
- repeated IVF failure
- recurrent pregnancy loss
Who cannot join
- uterine abnormalities
- endometriosis
- endocrinal diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site
European Hospital
Rome, 00148
Ermanno Greco, MD, 06-65975643, ergreco@virgilio.it
Ermanno greco, MD
About this study
The aim of this study is to performed a randomized controlled trial to evaluate the rate of genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocols.
Patients will be prospectively randomized in two groups: the first undergoing controlled ovarian stimulation in GnRH-agonist long protocol and the second following GnRH-antagonist ovarian stimulation regimen.
Read more
The end-points of the study include the number of genetically and chromosomally abnormal embryos, the pregnancy, the implantation and the healthy baby birth rate.
The patients included in PGS program were selected on the base of advanced maternal age, repeated pregnancy lost and implantation failure whereas the patients who were know to carry sex-linked or monogenic disorders were considered for PGD strategy.
The uterine abnormalities, endometriosis and endocrinal diseases were considered to be the exclusion factors.
- Conditions
- Embryo's Genetic and Chromosomal Quality
- Being tested
- ghrh antagonist (cetrotide/orgalutran), gnrh agonist (suprefact)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ghrh antagonist (cetrotide/orgalutran)Drug
cetrotide/orgalutran 0.25 mg
gnrh agonist (suprefact)Drug
suprefact 5.5 ml
| Study group | Role | What they receive |
|---|---|---|
| short protocol | Active comparator | gnrh agonist versus gnrh antagonist Receives: Drug: ghrh antagonist (cetrotide/orgalutran) |
| long protocol | Active comparator | Not described Receives: Drug: gnrh agonist (suprefact) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol
difference in embryos' genetic and chromosomal quality using two different ovarian stimulation protocol
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo's Genetic and Chromosomal QualityStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636505
- Sponsor's protocol ID
- ECK011170
- Status last verified
- Jul 2012
- First submitted
- 5 Jul 2012
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation Protocol
- ClinicalTrials.gov ID
- NCT01636505
- Acronym / sponsor ID
- ECK011170
- Conditions
- Embryo's Genetic and Chromosomal Quality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- European HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 10 Jul 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 aim of this study is to performed a randomized controlled trial to evaluate the rate of genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocols.
Patients will be prospectively randomized in two groups: the first undergoing controlled ovarian stimulation in GnRH-agonist long protocol and the second following GnRH-antagonist ovarian stimulation regimen.
The end-points of the study include the number of genetically and chromosomally abnormal embryos, the pregnancy, the implantation and the healthy baby birth rate.
The patients included in PGS program were selected on the base of advanced maternal age, repeated pregnancy lost and implantation failure whereas the patients who were know to carry sex-linked or monogenic disorders were considered for PGD strategy.
The uterine abnormalities, endometriosis and endocrinal diseases were considered to be the exclusion factors.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short protocol | Active comparator | Drug: ghrh antagonist (cetrotide/orgalutran)gnrh agonist versus gnrh antagonist |
| long protocol | Active comparator | Drug: gnrh agonist (suprefact) |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients carrier genetic disease
- advanced maternal Age
- repeated IVF failure
- recurrent pregnancy loss
Key exclusion criteria (3 listed)
- uterine abnormalities
- endometriosis
- endocrinal diseases
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 |
|---|---|---|
| ghrh antagonist (cetrotide/orgalutran)cetrotide/orgalutran 0.25 mg | Drug | short protocol |
| gnrh agonist (suprefact)suprefact 5.5 ml | Drug | long protocol |
Primary outcome
The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol
Time frame: one year
difference in embryos' genetic and chromosomal quality using two different ovarian stimulation protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
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.
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 ghrh antagonist (cetrotide/orgalutran) and gnrh agonist (suprefact) in people with Embryo's Genetic and Chromosomal Quality, run by European Hospital 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 4 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 10 Jul 2012. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol (time frame: one year). 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 10 Jul 2012.