InfertilityPhase 4NCT00553293
Nordic Luveris Study
A Phase 4 study testing recombinant luteinizing hormone (Luveris) and recombinant follicle stimulating hormone (Gonal-f) in people with Infertility and In Vitro Fertilization, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
To study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Infertility, In Vitro Fertilization
- What is being tested?
- recombinant luteinizing hormone (Luveris) and recombinant follicle stimulating hormone (Gonal-f)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 526 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2003to Nov 2004
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age below 40
- Infertility treatable by IVF or ICSI
- Regular cycles
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recombinant LH Supplementation to Recombinant FSH During the Final Days of Controlled Ovarian Stimulation for IVF: a Multicentre, Prospective, Randomized, Controlled Trial
To study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.
- Conditions
- Infertility, In Vitro Fertilization
- Being tested
- recombinant luteinizing hormone (Luveris), recombinant follicle stimulating hormone (Gonal-f)
- Keywords
- infertility, in vitro fertilization, LH supplementation, Benefits
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant luteinizing hormone (Luveris)Drug
Also called Luveris
75 iu/day form cycle day 6
recombinant follicle stimulating hormone (Gonal-f)Drug
Also called Gonal-f
rFSH 150 iu/day
| Study group | Role | What they receive |
|---|---|---|
| A,1 | Active comparator | rFSH + rLH arm Receives: Drug: recombinant luteinizing hormone (Luveris) |
| A,2 | Placebo comparator | rFSH alone Receives: Drug: recombinant follicle stimulating hormone (Gonal-f) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate per started stimulation cycle
Measured: ultrasound showing ongoing pregnancy
Secondary outcomes (1)
Ongoing pregnancy in subgroups of patients with lo0w serum LH levels
Measured: ultrasound for ongoing pregnancy in subgroups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startAug 2003
- Study completionNov 2004
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 InfertilityStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Viborg, Skive, Karolinska University Hospital, Helse Fonna, Turku Hospital, Odense University Hospital, Herlev Hospital, Holbaek Sygehus, Hvidovre University Hospital
- Investigators
- Anders N Andersen, professor, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553293
- Sponsor's protocol ID
- KF02-035/03
- Status last verified
- Nov 2007
- First submitted
- 2 Nov 2007
- Last updated
- 5 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
NyboeAndersen A, Humaidan P, Fried G, Hausken J, Antila L, Bangsboll S, Rasmussen PE, Lindenberg S, Bredkjaer HE, Meinertz H; Nordic LH study group. Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial. Hum Reprod. 2008 Feb;23(2):427-34. doi: 10.1093/humrep/dem317. Epub 2007 Nov 16.
PubMed 18024487
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant LH Supplementation to Recombinant FSH During the Final Days of Controlled Ovarian Stimulation for IVF: a Multicentre, Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00553293
- Acronym / sponsor ID
- KF02-035/03
- Conditions
- Infertility, In Vitro Fertilization
- Keywords
- infertility, in vitro fertilization, LH supplementation, Benefits
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Regionshospitalet Viborg, Skive, Karolinska University Hospital, Helse Fonna, Turku Hospital, Odense University Hospital, Herlev Hospital, Holbaek Sygehus, Hvidovre University Hospital
- Study start
- Aug 2003
- Study completion
- Nov 2004 (actual)
- First posted
- 5 Nov 2007 (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 study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A,1 | Active comparator | Drug: recombinant luteinizing hormone (Luveris)rFSH + rLH arm |
| A,2 | Placebo comparator | Drug: recombinant follicle stimulating hormone (Gonal-f)rFSH alone |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age below 40
- Infertility treatable by IVF or ICSI
- Regular cycles
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| recombinant luteinizing hormone (Luveris)Also: Luveris75 iu/day form cycle day 6 | Drug | A,1 |
| recombinant follicle stimulating hormone (Gonal-f)Also: Gonal-frFSH 150 iu/day | Drug | A,2 |
Primary outcome
Ongoing pregnancy rate per started stimulation cycle
Time frame: ultrasound showing ongoing pregnancy
1 secondary outcome
Ongoing pregnancy in subgroups of patients with lo0w serum LH levels
Time frame: ultrasound for ongoing pregnancy in subgroups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2007.
- Derived from this study: PubMed 18024487NyboeAndersen A, Humaidan P, Fried G, Hausken J, Antila L, Bangsboll S, Rasmussen PE, Lindenberg S, Bredkjaer HE, Meinertz H; Nordic LH study group. Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial. Hum Reprod. 2008 Feb;23(2):427-34. doi: 10.1093/humrep/dem317. Epub 2007 Nov 16.
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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.
Anders N Andersen, professor principal investigator
Copenhagen University Hospital, Rigshospitalet
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 recombinant luteinizing hormone (Luveris) and recombinant follicle stimulating hormone (Gonal-f) in people with Infertility and In Vitro Fertilization, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 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: finished, as of the sponsor's last update on 5 Nov 2007. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ongoing pregnancy rate per started stimulation cycle (time frame: ultrasound showing ongoing pregnancy). 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 NCT00553293, 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 5 Nov 2007; AzTrials last refreshed its copy on 29 Oct 2026.