InfertilityPhase 4NCT00417183
Comparison of the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation
A Phase 4 study testing Arvekap 0.1 mg (Triptorelin, Ipsen, France) and Ganirelix 0.25 (Orgalutran, Organon, The Netherlands) in people with Infertility, run by Eugonia at 1 site in Greece.
Trial summary
The purpose of this study is to compare the efficacy of two controlled ovarian stimulation protocols, the GnRH agonist protocol, widely known as the "long" protocol, and the flexible GnRH antagonist protocol, in terms of pregnancy rates and embryological data, in infertile patients receiving IVF treatment. Read more about this study
- Who is it for?
- Ages 21 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Arvekap 0.1 mg (Triptorelin, Ipsen, France) and Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)
- How many people
- 300 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2005to Jun 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 21 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-39 years
- Body mass index 18-29 kg/m2
- Menstrual cycle from 24-35 days
- Normal basal FSH (<10 IU/ml)
- Normal basal LH (<10 IU/ml)
- Normal basal estradiol (<80 pg/ml)
Who cannot join
- Poor responder patients
- Polycystic ovaries
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Eugonia
Athens, 11528
Tryfon Lainas, PhD, 00302107236333, ivf@eugonia.com.gr
About this study
Official title: Randomized Controlled Trial Comparing the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation in Normal Responders
The purpose of this study is to compare the efficacy of two controlled ovarian stimulation protocols, the GnRH agonist protocol, widely known as the "long" protocol, and the flexible GnRH antagonist protocol, in terms of pregnancy rates and embryological data, in infertile patients receiving IVF treatment.
Read the detailed description
The formulation of controlled ovarian stimulation protocols is one of the primary reasons for the successful development of IVF. The "long" GnRH agonist protocol, also known as the gold standard, has been widely used with considerable success. More recently, on the other hand, GnRH antagonist provide a new promising approach for endogenous gonadotrophin suppression by blocking the GnRH receptor. There is conflicting data in the literature regarding the relative merits of the two ovarian stimulation protocols.
COMPARISON: Pregnancy rates and embryological data will by assessed in IVF patients treated with either the "long" GnRH agonist (Arvekap) or the flexible GnRH antagonist (Ganirelix) protocol.
- Conditions
- Infertility
- Being tested
- Arvekap 0.1 mg (Triptorelin, Ipsen, France), Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)
- Keywords
- GnRH antagonist, GnRH agonist, Long protocol, Flexible
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arvekap 0.1 mg (Triptorelin, Ipsen, France)Drug
Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy per embryo transfer
Secondary outcomes (3)
Biochemical pregnancy per embryo transfer
Clinical pregnancy per embryo transfer
Embryological data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2006 (estimated)
- Study startSep 2005
- Study completionJun 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Eugonia
- Sponsor type
- University, hospital or other
- Investigators
- Tryfon Lainas, PhD, Principal investigator, Eugonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417183
- Sponsor's protocol ID
- long vs flexible
- Status last verified
- Dec 2006
- First submitted
- 22 Dec 2006
- Last updated
- 29 Dec 2006
- Results posted
- No
Publications
Lainas T, Zorzovilis J, Petsas G, Stavropoulou G, Cazlaris H, Daskalaki V, Lainas G, Alexopoulou E. In a flexible antagonist protocol, earlier, criteria-based initiation of GnRH antagonist is associated with increased pregnancy rates in IVF. Hum Reprod. 2005 Sep;20(9):2426-33. doi: 10.1093/humrep/dei106. Epub 2005 Jun 9.
PubMed 15946995
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation in Normal Responders
- ClinicalTrials.gov ID
- NCT00417183
- Acronym / sponsor ID
- long vs flexible
- Conditions
- Infertility
- Keywords
- GnRH antagonist, GnRH agonist, Long protocol, Flexible
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- EugoniaUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Jun 2007
- First posted
- 29 Dec 2006 (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 compare the efficacy of two controlled ovarian stimulation protocols, the GnRH agonist protocol, widely known as the "long" protocol, and the flexible GnRH antagonist protocol, in terms of pregnancy rates and embryological data, in infertile patients receiving IVF treatment.
Detailed description
The formulation of controlled ovarian stimulation protocols is one of the primary reasons for the successful development of IVF. The "long" GnRH agonist protocol, also known as the gold standard, has been widely used with considerable success. More recently, on the other hand, GnRH antagonist provide a new promising approach for endogenous gonadotrophin suppression by blocking the GnRH receptor. There is conflicting data in the literature regarding the relative merits of the two ovarian stimulation protocols.
COMPARISON: Pregnancy rates and embryological data will by assessed in IVF patients treated with either the "long" GnRH agonist (Arvekap) or the flexible GnRH antagonist (Ganirelix) protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-39 years
- Body mass index 18-29 kg/m2
- Menstrual cycle from 24-35 days
- Normal basal FSH (<10 IU/ml)
- Normal basal LH (<10 IU/ml)
Key exclusion criteria (2 listed)
- Poor responder patients
- Polycystic ovaries
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 |
|---|---|---|
| Arvekap 0.1 mg (Triptorelin, Ipsen, France) | Drug | – |
| Ganirelix 0.25 (Orgalutran, Organon, The Netherlands) | Drug | – |
Primary outcome
Ongoing pregnancy per embryo transfer
3 secondary outcomes
Biochemical pregnancy per embryo transfer
Clinical pregnancy per embryo transfer
Embryological data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2006.
- Background: PubMed 15946995Lainas T, Zorzovilis J, Petsas G, Stavropoulou G, Cazlaris H, Daskalaki V, Lainas G, Alexopoulou E. In a flexible antagonist protocol, earlier, criteria-based initiation of GnRH antagonist is associated with increased pregnancy rates in IVF. Hum Reprod. 2005 Sep;20(9):2426-33. doi: 10.1093/humrep/dei106. Epub 2005 Jun 9.
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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.
Tryfon Lainas, PhD principal investigator
Eugonia
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 Arvekap 0.1 mg (Triptorelin, Ipsen, France) and Ganirelix 0.25 (Orgalutran, Organon, The Netherlands) in people with Infertility, run by Eugonia at 1 site in Greece.
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 6 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: status not confirmed, as of the sponsor's last update on 29 Dec 2006. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tryfon Lainas, PhD (00302107236333, ivf@eugonia.com.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy per embryo transfer. 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 NCT00417183, 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 29 Dec 2006.