SubfertilityPhase 4NCT01005784
Fixed Versus Flexible Gonadotropin-releasing Hormone (GnRH) Antagonist Initiation
A Phase 4 study testing Cetrorelix (Cetrotide) in people with Subfertility, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
This is a comparison of pregnancy achievement between two GnRH antagonist protocols which differ in the timing of GnRH antagonist initiation. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- Cetrorelix (Cetrotide)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2005to Mar 2008
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- < 39 years of age
- BMI 18.5-29.9
- <= 3 previous IVF cycles
Who cannot join
- PCOS
- Endometriosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fixed Versus Flexible GnRH Antagonist Initiation
This is a comparison of pregnancy achievement between two GnRH antagonist protocols which differ in the timing of GnRH antagonist initiation.
- Conditions
- Subfertility
- Being tested
- Cetrorelix (Cetrotide)
- Keywords
- GnRH antagonists
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetrorelix (Cetrotide)Drug
Also called Cetrorelix, Cetrotide, Serono
flexible antagonist administration according to specified criteria
Cetrorelix (Cetrotide)Drug
Also called Cetrorelix, Cetrotide, Serono
fixed antagonist administration on day 6 of ovarian stimulation
| Study group | Role | What they receive |
|---|---|---|
| fixed | Active comparator | Not described Receives: Drug: Cetrorelix (Cetrotide) |
| flexible | Experimental | Not described Receives: Drug: Cetrorelix (Cetrotide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Luteinizing hormone rise
Measured: 3-14 days (duration of ovarian stimulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJun 2005
- Primary completionJan 2008
- Study completionMar 2008
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 SubfertilityStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Investigators
- Efstratios Kolibianakis, Principal investigator, Unit for Human Reproduction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005784
- Sponsor's protocol ID
- UHR-3
- Status last verified
- Oct 2009
- First submitted
- 13 Nov 2007
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Kolibianakis EM, Venetis CA, Kalogeropoulou L, Papanikolaou E, Tarlatzis BC. Fixed versus flexible gonadotropin-releasing hormone antagonist administration in in vitro fertilization: a randomized controlled trial. Fertil Steril. 2011 Feb;95(2):558-62. doi: 10.1016/j.fertnstert.2010.05.052. Epub 2010 Jul 16.
PubMed 20637457
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixed Versus Flexible GnRH Antagonist Initiation
- ClinicalTrials.gov ID
- NCT01005784
- Acronym / sponsor ID
- UHR-3
- Conditions
- Subfertility
- Keywords
- GnRH antagonists
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 2 Nov 2009 (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.
This is a comparison of pregnancy achievement between two GnRH antagonist protocols which differ in the timing of GnRH antagonist initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fixed | Active comparator | Drug: Cetrorelix (Cetrotide) |
| flexible | Experimental | Drug: Cetrorelix (Cetrotide) |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- < 39 years of age
- BMI 18.5-29.9
- <= 3 previous IVF cycles
Key exclusion criteria (2 listed)
- PCOS
- Endometriosis
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 |
|---|---|---|
| Cetrorelix (Cetrotide)Also: Cetrorelix, Cetrotide, Seronoflexible antagonist administration according to specified criteria | Drug | flexible |
| Cetrorelix (Cetrotide)Also: Cetrorelix, Cetrotide, Seronofixed antagonist administration on day 6 of ovarian stimulation | Drug | fixed |
Primary outcome
Luteinizing hormone rise
Time frame: 3-14 days (duration of ovarian stimulation)
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 2 Nov 2009.
- Derived from this study: PubMed 20637457Kolibianakis EM, Venetis CA, Kalogeropoulou L, Papanikolaou E, Tarlatzis BC. Fixed versus flexible gonadotropin-releasing hormone antagonist administration in in vitro fertilization: a randomized controlled trial. Fertil Steril. 2011 Feb;95(2):558-62. doi: 10.1016/j.fertnstert.2010.05.052. Epub 2010 Jul 16.
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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.
Efstratios Kolibianakis principal investigator
Unit for Human Reproduction
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 Cetrorelix (Cetrotide) in people with Subfertility, run by Aristotle University Of Thessaloniki 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 3 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: finished, as of the sponsor's last update on 2 Nov 2009. 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?
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?
Luteinizing hormone rise (time frame: 3-14 days (duration of ovarian stimulation)). 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 NCT01005784, 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 2 Nov 2009.