PregnancyPhase 4NCT00954811
Luteal Supplementation With Rec-LH After GnRH-agonist Triggering in In Vitro (IVF)
A Phase 4 study testing 300IU rec-LH and progesterone 600mg in people with Pregnancy and Pregnancy Loss, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Our aim is to access whether we can achieve equivalent pregnancy rates by the addition of six doses of luteal support with recLH after agonist triggering for IVF cycles in the absence of OHSS. Read more about this study
- Who is it for?
- Ages 20 to 36 years, women only
- Conditions the study is for
- Pregnancy, Pregnancy Loss
- What is being tested?
- 300IU rec-LH and progesterone 600mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2005to Dec 2010
- 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 20 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- < 36years,
- single blastocystET,
- FSH < 12
Who cannot join
- endometriosis,
- 3 and 4,
- pco,
- frozen sperm
Trial locations and contacts
1 site in 1 country.
Evangelos Papanikolaou, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
Centre for Reproductive Medicine, UZ Brussel
Brussels, Jette, 1090
Evangelos Papanikolaou, MD,PhD, 0032 2 4776606, drvagpapanikolaou@yahoo.gr
About this study
Official title: A Phase IV Study on the Effect of Luteal Supplementation With Rec-LH on the Pregnancy Rate After Ovulation Triggering With GnRH-agonist Instead of HCG in IVF Protocol;Proof of Concept
Our aim is to access whether we can achieve equivalent pregnancy rates by the addition of six doses of luteal support with recLH after agonist triggering for IVF cycles in the absence of OHSS.
Read the detailed description
Whether pregnancy outcome after GnRH-agonist triggering could be improved by adding luteal recLH support plus progesterone, compared to that observed after ovulation triggering with HCG in GnRH antagonist stimulated cycles.
- Conditions
- Pregnancy, Pregnancy Loss
- Being tested
- 300IU rec-LH, progesterone 600mg
- Keywords
- pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300IU rec-LHDrug
luteal alternate doses
progesterone 600mgDrug
luteal support
| Study group | Role | What they receive |
|---|---|---|
| HCG for ovulation triggering and luteal progesterone | Active comparator | conventional triggering with HCG and conventional luteal support with progesterone Receives: Drug: progesterone 600mg |
| Agonist triggering and rec-LH luteal support plus progesterone | Experimental | new method of triggering with GnRH-agonist and proof of concept intervention with novel way of luteal support with rec-LH plus the usual co-treatment with progesterone Receives: Drug: 300IU rec-LH |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy occurrence, pregnancy loss
Measured: 14 days after OPU
Secondary outcomes (1)
hormone levels, OHSS, endometrium
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 startSep 2005
- Primary completionJan 2008 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono International SA
- Investigators
- Paul Devroey, Study chair, Professor or OB-GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954811
- Sponsor's protocol ID
- recombinant LH 1505
- Status last verified
- Aug 2009
- First submitted
- 6 Aug 2009
- Last updated
- 8 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Study on the Effect of Luteal Supplementation With Rec-LH on the Pregnancy Rate After Ovulation Triggering With GnRH-agonist Instead of HCG in IVF Protocol;Proof of Concept
- ClinicalTrials.gov ID
- NCT00954811
- Acronym / sponsor ID
- recombinant LH 1505
- Conditions
- Pregnancy, Pregnancy Loss
- Keywords
- pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Merck Serono International SA
- Study start
- Sep 2005
- Primary completion
- Jan 2008 (estimated)
- Study completion
- Dec 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.
Our aim is to access whether we can achieve equivalent pregnancy rates by the addition of six doses of luteal support with recLH after agonist triggering for IVF cycles in the absence of OHSS.
Detailed description
Whether pregnancy outcome after GnRH-agonist triggering could be improved by adding luteal recLH support plus progesterone, compared to that observed after ovulation triggering with HCG in GnRH antagonist stimulated cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCG for ovulation triggering and luteal progesterone | Active comparator | Drug: progesterone 600mgconventional triggering with HCG and conventional luteal support with progesterone |
| Agonist triggering and rec-LH luteal support plus progesterone | Experimental | Drug: 300IU rec-LHnew method of triggering with GnRH-agonist and proof of concept intervention with novel way of luteal support with rec-LH plus the usual co-treatment with progesterone |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- < 36years,
- single blastocystET,
- FSH < 12
Key exclusion criteria (4 listed)
- endometriosis,
- 3 and 4,
- pco,
- frozen sperm
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 |
|---|---|---|
| 300IU rec-LHluteal alternate doses | Drug | Agonist triggering and rec-LH luteal support plus progesterone |
| progesterone 600mgluteal support | Drug | HCG for ovulation triggering and luteal progesterone |
Primary outcome
pregnancy occurrence, pregnancy loss
Time frame: 14 days after OPU
1 secondary outcome
hormone levels, OHSS, endometrium
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 8 Jan 2010.
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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.
Evangelos Papanikolaou, PhD contact
Paul Devroey study chair
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 4 study testing 300IU rec-LH and progesterone 600mg in people with Pregnancy and Pregnancy Loss, 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 4 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 8 Jan 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 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 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, PhD (drvagpapanikolaou@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy occurrence, pregnancy loss (time frame: 14 days after OPU). 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 8 Jan 2010.