Pregnancy Outcome After In Vitro Fertilization (IVF)Phase 4NCT01191710
Progesterone Rise in Agonist Versus Antagonist in Vitro Fertilization (IVF) Cycles
A Phase 4 study testing In vitro fertilization in people with Pregnancy Outcome After In Vitro Fertilization (IVF), run by Universitair Ziekenhuis Brussel at 1 site in Greece.
Trial summary
The aim is to explore whether the incidence of progesterone rise in the late follicular phase differs between GnRH-agonist and GnRH-antagonist protocols for IVF and whether this has an impact on the probability of pregnancy achievement. Read more about this study
- Who is it for?
- Ages 21 to 39 years, women only
- Conditions the study is for
- Pregnancy Outcome After In Vitro Fertilization (IVF)
- What is being tested?
- In vitro fertilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2007to Jan 2011
- 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
- No healthy volunteers
- Adult
Who may be able to join
- age < 39
- follicle-stimulating hormone (FSH) < 12
- gonadotropin dose 100-300IU
Who cannot join
- endometriosis
- known endocrine disorder
- blood analyzed in another laboratory
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Clinical Outcome Affected by the Incidence of Progesterone Elevation on the Day of hCG Triggering When Agonist Protocol is Compared to Antagonist Protocol for IVF
The aim is to explore whether the incidence of progesterone rise in the late follicular phase differs between GnRH-agonist and GnRH-antagonist protocols for IVF and whether this has an impact on the probability of pregnancy achievement.
Read the detailed description
In view of the current debate concerning possible differences in efficacy between the two GnRH analogues, the current study aimed to explore whether progesterone control in the late follicular phase differs when GnRH-agonist is used as compared to GnRH-antagonist and if so to what extend does the progesterone rise have an impact on the probability of achieving a pregnancy.
- Being tested
- In vitro fertilization
- Keywords
- progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro fertilizationOther
Also called IVF, pregnancy, embryo-transfer, progesterone
In vitro fertilization procedure with gonadotropin induced follicular ovarian stimulation
| Study group | Role | What they receive |
|---|---|---|
| Antagonist group | Experimental | Antagonist protocol for IVF Receives: Other: In vitro fertilization |
| Agonist group | Active comparator | Long Agonist protocol for IVF Receives: Other: In vitro fertilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of late progesterone rise on the day of HCG triggering
Measured: Up to delivery (2010)
Secondary outcomes (1)
Clinical pregnancy rate Delivery rate
Measured: Up to delivery (2010)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startJan 2007
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
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 Pregnancy Outcome After In Vitro Fertilization (IVF)Studies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- BioGenesis
- Investigators
- Basil Tarlatzis, MD, Study chair, BioGenesis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191710
- Sponsor's protocol ID
- ProgRise001
- Status last verified
- Jan 2009
- First submitted
- 27 Aug 2010
- Last updated
- 15 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Papanikolaou EG, Kolibianakis EM, Pozzobon C, Tank P, Tournaye H, Bourgain C, Van Steirteghem A, Devroey P. Progesterone rise on the day of human chorionic gonadotropin administration impairs pregnancy outcome in day 3 single-embryo transfer, while has no effect on day 5 single blastocyst transfer. Fertil Steril. 2009 Mar;91(3):949-52. doi: 10.1016/j.fertnstert.2006.12.064. Epub 2007 Jun 6.
PubMed 17555751Papanikolaou EG, Pados G, Grimbizis G, Bili E, Kyriazi L, Polyzos NP, Humaidan P, Tournaye H, Tarlatzis B. GnRH-agonist versus GnRH-antagonist IVF cycles: is the reproductive outcome affected by the incidence of progesterone elevation on the day of HCG triggering? A randomized prospective study. Hum Reprod. 2012 Jun;27(6):1822-8. doi: 10.1093/humrep/des066. Epub 2012 Mar 14.
PubMed 22422777
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Clinical Outcome Affected by the Incidence of Progesterone Elevation on the Day of hCG Triggering When Agonist Protocol is Compared to Antagonist Protocol for IVF
- ClinicalTrials.gov ID
- NCT01191710
- Acronym / sponsor ID
- ProgRise001
- Keywords
- progesterone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- BioGenesis
- Study start
- Jan 2007
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 31 Aug 2010 (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 is to explore whether the incidence of progesterone rise in the late follicular phase differs between GnRH-agonist and GnRH-antagonist protocols for IVF and whether this has an impact on the probability of pregnancy achievement.
Detailed description
In view of the current debate concerning possible differences in efficacy between the two GnRH analogues, the current study aimed to explore whether progesterone control in the late follicular phase differs when GnRH-agonist is used as compared to GnRH-antagonist and if so to what extend does the progesterone rise have an impact on the probability of achieving a pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antagonist group | Experimental | Other: In vitro fertilizationAntagonist protocol for IVF |
| Agonist group | Active comparator | Other: In vitro fertilizationLong Agonist protocol for IVF |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age < 39
- follicle-stimulating hormone (FSH) < 12
- gonadotropin dose 100-300IU
Key exclusion criteria (3 listed)
- endometriosis
- known endocrine disorder
- blood analyzed in another laboratory
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 |
|---|---|---|
| In vitro fertilizationAlso: IVF, pregnancy, embryo-transfer, progesteroneIn vitro fertilization procedure with gonadotropin induced follicular ovarian stimulation | Other | Agonist group, Antagonist group |
Primary outcome
Incidence of late progesterone rise on the day of HCG triggering
Time frame: Up to delivery (2010)
1 secondary outcome
Clinical pregnancy rate Delivery rate
Time frame: Up to delivery (2010)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2010.
- Background: PubMed 17555751Papanikolaou EG, Kolibianakis EM, Pozzobon C, Tank P, Tournaye H, Bourgain C, Van Steirteghem A, Devroey P. Progesterone rise on the day of human chorionic gonadotropin administration impairs pregnancy outcome in day 3 single-embryo transfer, while has no effect on day 5 single blastocyst transfer. Fertil Steril. 2009 Mar;91(3):949-52. doi: 10.1016/j.fertnstert.2006.12.064. Epub 2007 Jun 6.
- Derived from this study: PubMed 22422777Papanikolaou EG, Pados G, Grimbizis G, Bili E, Kyriazi L, Polyzos NP, Humaidan P, Tournaye H, Tarlatzis B. GnRH-agonist versus GnRH-antagonist IVF cycles: is the reproductive outcome affected by the incidence of progesterone elevation on the day of HCG triggering? A randomized prospective study. Hum Reprod. 2012 Jun;27(6):1822-8. doi: 10.1093/humrep/des066. Epub 2012 Mar 14.
- Related InfoLink provided by the sponsor.
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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.
Basil Tarlatzis, MD study chair
BioGenesis
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 In vitro fertilization in people with Pregnancy Outcome After In Vitro Fertilization (IVF), run by Universitair Ziekenhuis Brussel 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 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 15 Sep 2010. 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?
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?
Incidence of late progesterone rise on the day of HCG triggering (time frame: Up to delivery (2010)). 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 NCT01191710, 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 15 Sep 2010.