In Vitro FertilizationPhase 4NCT01220791
Methylprednisolone Addition in IVF Treatment of Infertile Couples
A Phase 4 study testing In vitro fertilization treatment for infertility in people with In Vitro Fertilization, run by Universitair Ziekenhuis Brussel at 1 site in Greece.
Trial summary
Hypothesis to be tested is whether follicular addition of Methylprednisolone can efficiently control late follicular progesterone rise during IVF treatment Read more about this study
- Who is it for?
- Ages 21 to 36 years, women only
- Conditions the study is for
- In Vitro Fertilization
- What is being tested?
- In vitro fertilization treatment for infertility
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2009to Dec 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 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- less than 36, more than 10 antral follicles, FSH<12
Who cannot join
- endometriosis stage III\&IV,
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Biogenesis
Thessaloniki, Pylaia, 55536
Evangelos Papanikolaou, MD,PhD, 0030 2310 989160, drvagpapanikolaou@yahoo.gr
About this study
Official title: Methylprednisolone vs. Placebo to Control Late Follicular Progesterone Elevation in GnRH-Antagonist IVF Cycles
Hypothesis to be tested is whether follicular addition of Methylprednisolone can efficiently control late follicular progesterone rise during IVF treatment
Read the detailed description
The aim is to investigate any potential advantages of adding cortisone supplementation from the follicular phase onwards with regard to premature luteinization, oocyte quality, embryo quality and pregnancy outcome.
- Conditions
- In Vitro Fertilization
- Being tested
- In vitro fertilization treatment for infertility
- Keywords
- methylprednisolone, IVF, progesterone, corticosteroid, late follicular phase, pregnancy rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro fertilization treatment for infertilityOther
Also called pregnancy, MEDROL, progesterone
IVF treatment
| Study group | Role | What they receive |
|---|---|---|
| Follicular Medrol | Active comparator | In an Antagonist protocol for IVF patients will also receive 4mg tabl. Methylprednisolone twice a day from the day 2 of ovarian stimulation and until the day of the pregnancy test on luteal day-14 post oocyte retrieval Receives: Other: In vitro fertilization treatment for infertility |
| No medrol group | Placebo comparator | Patients will receive only Antagonist protocol for IVF as usual Receives: Other: In vitro fertilization treatment for infertility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progesterone rise above 1.5ng.ml on the day of HCG
Incidence or high progesterone on the day of HCG triggering
Measured: up to 14 days of follicular ovarian stimulation
Secondary outcomes (1)
Clinical pregnancy rate
Success rate in IVF cycles
Measured: Follow pregnancy until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
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 In Vitro FertilizationStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- BioGenesis, HRG
- Investigators
- Basil Tarlatzis, Professor, Study chair, BioGenesis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220791
- Sponsor's protocol ID
- Medrol005
- Status last verified
- Oct 2010
- First submitted
- 27 Aug 2010
- Last updated
- 14 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Bider D, Menashe Y, Goldenberg M, Dulitzky M, Lifshitz A, Dor J. Dexamethasone as an adjuvant therapy for anovulatory, normoandrogenic patients during ovulation induction with exogenous gonadotropins. J Assist Reprod Genet. 1996 Sep;13(8):613-6. doi: 10.1007/BF02069638.
PubMed 8897119
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylprednisolone vs. Placebo to Control Late Follicular Progesterone Elevation in GnRH-Antagonist IVF Cycles
- ClinicalTrials.gov ID
- NCT01220791
- Acronym / sponsor ID
- Medrol005
- Conditions
- In Vitro Fertilization
- Keywords
- methylprednisolone, IVF, progesterone, corticosteroid, late follicular phase, pregnancy rates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- BioGenesis, HRG
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 14 Oct 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.
Hypothesis to be tested is whether follicular addition of Methylprednisolone can efficiently control late follicular progesterone rise during IVF treatment
Detailed description
The aim is to investigate any potential advantages of adding cortisone supplementation from the follicular phase onwards with regard to premature luteinization, oocyte quality, embryo quality and pregnancy outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follicular Medrol | Active comparator | Other: In vitro fertilization treatment for infertilityIn an Antagonist protocol for IVF patients will also receive 4mg tabl. Methylprednisolone twice a day from the day 2 of ovarian stimulation and until the day of the pregnancy test on luteal day-14 post oocyte retrieval |
| No medrol group | Placebo comparator | Other: In vitro fertilization treatment for infertilityPatients will receive only Antagonist protocol for IVF as usual |
Who may qualify
- Ages
- 21 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- less than 36, more than 10 antral follicles, FSH<12
Key exclusion criteria (1 listed)
- endometriosis stage III\&IV,
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 fertilization treatment for infertilityAlso: pregnancy, MEDROL, progesteroneIVF treatment | Other | Follicular Medrol, No medrol group |
Primary outcome
Progesterone rise above 1.5ng.ml on the day of HCG
Time frame: up to 14 days of follicular ovarian stimulation
Incidence or high progesterone on the day of HCG triggering
1 secondary outcome
Clinical pregnancy rate
Time frame: Follow pregnancy until delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2010.
- Background: PubMed 8897119Bider D, Menashe Y, Goldenberg M, Dulitzky M, Lifshitz A, Dor J. Dexamethasone as an adjuvant therapy for anovulatory, normoandrogenic patients during ovulation induction with exogenous gonadotropins. J Assist Reprod Genet. 1996 Sep;13(8):613-6. doi: 10.1007/BF02069638.
- web page of investigator centreLink provided by the sponsor.
Related trials for In Vitro Fertilization
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
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, Professor 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 treatment for infertility in people with In Vitro Fertilization, 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 1 inclusion and 1 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 14 Oct 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. Some participants in this study may receive a placebo. 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 Evangelos Papanikolaou, MD (0030 2310 424284, drvagpapanikolaou@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progesterone rise above 1.5ng.ml on the day of HCG (time frame: up to 14 days of follicular 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 NCT01220791, 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 14 Oct 2010.