Embryonic DevelopmentPhase 3NCT00954265
Pregnancy Rates in IVF After Ovulation Triggering With Recombinant or Urinary Human Chorionic Gonadotrophin (HCG)
A Phase 3 study testing 10000 IU urinary HCG and 250 mcg recombinant HCG in people with Embryonic Development and Pregnancy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
To access whether the ovulation triggering with rec-HCG instead urinary-HCG has any impact on the blastulation rate and pregnancy rate of patients undergoing IVF treatment Read more about this study
- Who is it for?
- Ages 20 to 36 years, women only
- Conditions the study is for
- Embryonic Development, Pregnancy, VEGF
- What is being tested?
- 10000 IU urinary HCG and 250 mcg recombinant HCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2005to Sep 2010
- Phase
- Phase 3
- 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 20 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- FSH<12,
- normal sperm,less than 36y,
- single blastocyst transfer
Who cannot join
- endometriosis stage 3\&4,
- pco
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Centre for Reproductive Medicine, UZ Brussel
Brussels, Jette, 1090
About this study
Official title: Phase III Study on the Effects of Recombinant HCG Ovulation Triggering on Stimulation, Embryonic and Pregnancy Parameters in an IVF Program
To access whether the ovulation triggering with rec-HCG instead urinary-HCG has any impact on the blastulation rate and pregnancy rate of patients undergoing IVF treatment
- Conditions
- Embryonic Development, Pregnancy, VEGF
- Being tested
- 10000 IU urinary HCG, 250 mcg recombinant HCG
- Keywords
- pregnancy occurence, OHSS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10000 IU urinary HCGDrug
ovulation triggering
250 mcg recombinant HCGDrug
ovulation triggering
| Study group | Role | What they receive |
|---|---|---|
| Urinary-HCG group | Active comparator | These patients received u-HCG for ovulation triggering during ovarian stimulation for IVF Receives: Drug: 10000 IU urinary HCG |
| Recombinant HCG group | Experimental | These patients received rec-HCG for ovulation triggering during ovarian stimulation for IVF Receives: Drug: 250 mcg recombinant HCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
blastulation rate
Measured: on day-5
Secondary outcomes (1)
pregnancy rates, VEGF levels, OHSS rate
Measured: 14 days after oocyte pick up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startAug 2005
- Primary completionDec 2007 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryonic DevelopmentStudies 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 3
- 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
- Merck Serono International SA
- Investigators
- Paul Devroey, Professor, Study director, Professor or OB-GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954265
- Sponsor's protocol ID
- rec-HCG 002
- Status last verified
- Aug 2009
- First submitted
- 6 Aug 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study on the Effects of Recombinant HCG Ovulation Triggering on Stimulation, Embryonic and Pregnancy Parameters in an IVF Program
- ClinicalTrials.gov ID
- NCT00954265
- Acronym / sponsor ID
- rec-HCG 002
- Conditions
- Embryonic Development, Pregnancy, VEGF
- Keywords
- pregnancy occurence, OHSS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Merck Serono International SA
- Study start
- Aug 2005
- Primary completion
- Dec 2007 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 7 Aug 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.
To access whether the ovulation triggering with rec-HCG instead urinary-HCG has any impact on the blastulation rate and pregnancy rate of patients undergoing IVF treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary-HCG group | Active comparator | Drug: 10000 IU urinary HCGThese patients received u-HCG for ovulation triggering during ovarian stimulation for IVF |
| Recombinant HCG group | Experimental | Drug: 250 mcg recombinant HCGThese patients received rec-HCG for ovulation triggering during ovarian stimulation for IVF |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- FSH<12,
- normal sperm,less than 36y,
- single blastocyst transfer
Key exclusion criteria (2 listed)
- endometriosis stage 3\&4,
- pco
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 |
|---|---|---|
| 10000 IU urinary HCGovulation triggering | Drug | Urinary-HCG group |
| 250 mcg recombinant HCGovulation triggering | Drug | Recombinant HCG group |
Primary outcome
blastulation rate
Time frame: on day-5
1 secondary outcome
pregnancy rates, VEGF levels, OHSS rate
Time frame: 14 days after oocyte pick up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
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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.
Paul Devroey, Professor study director
Professor or OB-GYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10000 IU urinary HCG and 250 mcg recombinant HCG in people with Embryonic Development and Pregnancy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 24 Dec 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 Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
blastulation rate (time frame: on day-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2009.