Polycystic Ovary SyndromePhase 4NCT00417144
Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients
A Phase 4 study testing Arvekap 0.1mg (Triptorelin, Ipsen, France) and Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands) in people with Polycystic Ovary Syndrome and Ovarian Hyperstimulation Syndrome, run by Eugonia at 1 site in Greece.
Trial summary
The purpose of this study is to compare pregnancy rates and the occurrence of OHSS in PCOS patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation during an IVF cycle. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Ovarian Hyperstimulation Syndrome
- What is being tested?
- Arvekap 0.1mg (Triptorelin, Ipsen, France) and Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2003to May 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of PCOS (presence of oligo-ovulation/anovulation and polycystic ovaries)
Who cannot join
- Normal responders
- Poor responders
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 Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients
The purpose of this study is to compare pregnancy rates and the occurrence of OHSS in PCOS patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation during an IVF cycle. Our hypothesis is that the GnRH antagonist protocol reduces the occurrence and severity of OHSS compared to the GnRH agonist protocol.
Read the detailed description
Women with polycystic ovarian syndrome (PCOS) represent a group of patients at high risk of developing ovarian hyperstimulation syndrome (OHSS), an iatrogenic complication of ovarian stimulation during IVF treatment. In contrast to mild OHSS, severe OHSS is a life-threatening complication, characterized by massive ovarian enlargement, ascites, pleural effusion, oliguria, haemoconcentration and thromboembolic phenomena. Currently, no curative therapy for OHSS is available and thus prevention is considered the most effective "treatment". Several measures have been adopted to reduce the occurrence of the syndrome, the most effective being cycle cancellation and withholding of human chorionic gonadotropin (hCG), which seems to be the most critical factor for the development of OHSS.
COMPARISON: This study aims to compare the development and severity of OHSS, as well as ongoing pregnancy rates in PCOS patients who received a flexible GnRH antagonist (Ganirelix) protocol vs a long GnRH agonist (Arvekap) protocol of ovarian stimulation.
- Being tested
- Arvekap 0.1mg (Triptorelin, Ipsen, France), Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)
- Keywords
- OHSS, PCOS, GnRH antagonist, GnRH agonist
- Medical subject headings
- Polycystic Ovary Syndrome, Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arvekap 0.1mg (Triptorelin, Ipsen, France)Drug
Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of OHSS
Ongoing pregnancy rate per embryo transfer
Secondary outcomes (3)
Biochemical pregnancy
Clinical pregnancy
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 startNov 2003
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT00417144
- Sponsor's protocol ID
- ag vs antag PCOS
- Status last verified
- Dec 2006
- First submitted
- 22 Dec 2006
- Last updated
- 29 Dec 2006
- Results posted
- No
Publications
Aboulghar MA, Mansour RT. Ovarian hyperstimulation syndrome: classifications and critical analysis of preventive measures. Hum Reprod Update. 2003 May-Jun;9(3):275-89. doi: 10.1093/humupd/dmg018.
PubMed 12859048Lainas TG, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas GT, Alexopoulou E, Kolibianakis EM. Flexible GnRH antagonist protocol versus GnRH agonist long protocol in patients with polycystic ovary syndrome treated for IVF: a prospective randomised controlled trial (RCT). Hum Reprod. 2010 Mar;25(3):683-9. doi: 10.1093/humrep/dep436. Epub 2009 Dec 15.
PubMed 20008886
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 Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients
- ClinicalTrials.gov ID
- NCT00417144
- Acronym / sponsor ID
- ag vs antag PCOS
- Keywords
- OHSS, PCOS, GnRH antagonist, GnRH agonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- EugoniaUniversity, hospital or other
- Study start
- Nov 2003
- Study completion
- May 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 pregnancy rates and the occurrence of OHSS in PCOS patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation during an IVF cycle. Our hypothesis is that the GnRH antagonist protocol reduces the occurrence and severity of OHSS compared to the GnRH agonist protocol.
Detailed description
Women with polycystic ovarian syndrome (PCOS) represent a group of patients at high risk of developing ovarian hyperstimulation syndrome (OHSS), an iatrogenic complication of ovarian stimulation during IVF treatment. In contrast to mild OHSS, severe OHSS is a life-threatening complication, characterized by massive ovarian enlargement, ascites, pleural effusion, oliguria, haemoconcentration and thromboembolic phenomena. Currently, no curative therapy for OHSS is available and thus prevention is considered the most effective "treatment". Several measures have been adopted to reduce the occurrence of the syndrome, the most effective being cycle cancellation and withholding of human chorionic gonadotropin (hCG), which seems to be the most critical factor for the development of OHSS.
COMPARISON: This study aims to compare the development and severity of OHSS, as well as ongoing pregnancy rates in PCOS patients who received a flexible GnRH antagonist (Ganirelix) protocol vs a long GnRH agonist (Arvekap) protocol of ovarian stimulation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of PCOS (presence of oligo-ovulation/anovulation and polycystic ovaries)
Key exclusion criteria (2 listed)
- Normal responders
- Poor responders
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 0.1mg (Triptorelin, Ipsen, France) | Drug | – |
| Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands) | Drug | – |
Primary outcome
Development of OHSS
Ongoing pregnancy rate per embryo transfer
3 secondary outcomes
Biochemical pregnancy
Clinical pregnancy
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 12859048Aboulghar MA, Mansour RT. Ovarian hyperstimulation syndrome: classifications and critical analysis of preventive measures. Hum Reprod Update. 2003 May-Jun;9(3):275-89. doi: 10.1093/humupd/dmg018.
- Derived from this study: PubMed 20008886Lainas TG, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas GT, Alexopoulou E, Kolibianakis EM. Flexible GnRH antagonist protocol versus GnRH agonist long protocol in patients with polycystic ovary syndrome treated for IVF: a prospective randomised controlled trial (RCT). Hum Reprod. 2010 Mar;25(3):683-9. doi: 10.1093/humrep/dep436. Epub 2009 Dec 15.
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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 0.1mg (Triptorelin, Ipsen, France) and Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands) in people with Polycystic Ovary Syndrome and Ovarian Hyperstimulation Syndrome, 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 1 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?
Development of OHSS. 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?
On the ClinicalTrials.gov record for NCT00417144, which also lists 2 linked publications.
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.