in Vitro FertilizationPhase 4LITENCT00823472
Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF)
A Phase 4 study testing Mild stimulation in people with in Vitro Fertilization and Ovulation Induction, run by UMC Utrecht at 2 sites in 2 countries.
Trial summary
Background of the study: Milder stimulation protocols have the advantage of being less expensive and more patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to lower embryo aneuploidy rates compared to conventional treatment regimens. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- in Vitro Fertilization, Ovulation Induction
- What is being tested?
- Mild stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2009to Oct 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female age < 36 years
- FSH < 12 IU/l
- BMI 18-29 kg/m2
- Regular cycle (25-35 days)
- No major uterine or ovarian abnormalities
- No previous IVF cycles
- Written informed consent
Who cannot join
- Oocyte donation
- Medical contra indication for pregnancy or IVF treatment
- Endometriosis ≥ grade 3
- Polycystic Ovarium Syndrome (PCOS)
- Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Among IVF Patients Undergoing Fixed Antagonist Protocols With Recombinant FSH, Does Administration of Recombinant FSH From Cycle Day 5 Onwards Compared With Cycle Day 2 Onwards, Yield a Higher Number of Good Quality Embryos?
Background of the study:
Milder stimulation protocols have the advantage of being less expensive and more patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to lower embryo aneuploidy rates compared to conventional treatment regimens. Although with mild stimulation protocols the expected number of oocytes retrieved will be lower, pregnancy rates have shown to be similar possibly because embryo quality outfavours embryo quantity.
Read more
Objective of the study:
The aim of the study is to determine whether cycle day (CD) 5 start of stimulation will lead to better quality of embryos, based on morphology, than CD 2 start, in IVF with GnRH antagonist co-treatment started on a fixed day.
Study design:
Prospective randomized trial comparing two different starting days of ovarium stimulation (day 2 versus day 5) for IVF treatment.
Intervention:
One group wil start on cycle day 2 with stimulation of the ovaries with recombinant FSH. The other group will start on cycle day 5. Both group will start suppressing the gonadotrophin production of the the pituitary gland on cycle day 6 with a GnRH antagonist.
Primary study parameters/outcome of the study:
Primary outcome parameter is number of top embryos per ovum pick up.
Secondary study parameters/outcome of the study:
Secondary outcome measures are duration of stimulation, cancellation rate, fertilization rate, number of cumulus oocyte complexes obtained, number of mature oocytes obtained, number of top embryos per started cycle, amount of IU recFSH, and clinical pregnancy rate.
- Conditions
- in Vitro Fertilization, Ovulation Induction
- Being tested
- Mild stimulation
- Keywords
- embryonic structures, sperm injections, intracytoplasmic, IVF, GnRH antagonist, ovarian stimulation, cycle day 2 versus cycle day 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild stimulationDrug
Also called Puregon, Ganirelix
Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm
| Study group | Role | What they receive |
|---|---|---|
| Start rFSH cycle day 2 | Experimental | Not described Receives: Drug: Mild stimulation |
| Start rFSH on cycle day 5 | Experimental | Not described Receives: Drug: Mild stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Top Embryos Per OPU.
Proportion of top embryos per ovum pick-up
Measured: 1 year
Secondary outcomes (1)
Number of Cumulus Oocyte Complexes Obtained
Number of cumulus oocyte complexes obtained after ovum pick-up
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Inclusion of the study didn't go as fast as expected. Expect: 234 patients in 1 year in 2 centers. After 1,5 year only 147 patients were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 UMC UtrechtThe 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Responsible party
- Principal investigator, Bart CJM Fauser, UMC Utrecht
- Investigators
- Bart C Fauser, Prof, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823472
- Sponsor's protocol ID
- LITE study
- Other IDs
- CCMO: NL2370504108, METC: 08/233
- Acronym
- LITE
- Status last verified
- Jan 2019
- First submitted
- 13 Jan 2009
- Last updated
- 29 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hohmann FP, Macklon NS, Fauser BC. A randomized comparison of two ovarian stimulation protocols with gonadotropin-releasing hormone (GnRH) antagonist cotreatment for in vitro fertilization commencing recombinant follicle-stimulating hormone on cycle day 2 or 5 with the standard long GnRH agonist protocol. J Clin Endocrinol Metab. 2003 Jan;88(1):166-73. doi: 10.1210/jc.2002-020788.
PubMed 12519847
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Among IVF Patients Undergoing Fixed Antagonist Protocols With Recombinant FSH, Does Administration of Recombinant FSH From Cycle Day 5 Onwards Compared With Cycle Day 2 Onwards, Yield a Higher Number of Good Quality Embryos?
- ClinicalTrials.gov ID
- NCT00823472
- Acronym / sponsor ID
- LITE / LITE study
- Conditions
- in Vitro Fertilization, Ovulation Induction
- Keywords
- embryonic structures, sperm injections, intracytoplasmic, IVF, GnRH antagonist, ovarian stimulation, cycle day 2 versus cycle day 5
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion of the study didn't go as fast as expected. Expect: 234 patients in 1 year in 2 centers. After 1,5 year only 147 patients were recruited.
- Enrolment
- 147 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Study start
- Jan 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Posted 2 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background of the study:
Milder stimulation protocols have the advantage of being less expensive and more patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to lower embryo aneuploidy rates compared to conventional treatment regimens. Although with mild stimulation protocols the expected number of oocytes retrieved will be lower, pregnancy rates have shown to be similar possibly because embryo quality outfavours embryo quantity.
Objective of the study:
The aim of the study is to determine whether cycle day (CD) 5 start of stimulation will lead to better quality of embryos, based on morphology, than CD 2 start, in IVF with GnRH antagonist co-treatment started on a fixed day.
Study design:
Prospective randomized trial comparing two different starting days of ovarium stimulation (day 2 versus day 5) for IVF treatment.
Intervention:
One group wil start on cycle day 2 with stimulation of the ovaries with recombinant FSH. The other group will start on cycle day 5. Both group will start suppressing the gonadotrophin production of the the pituitary gland on cycle day 6 with a GnRH antagonist.
Primary study parameters/outcome of the study:
Primary outcome parameter is number of top embryos per ovum pick up.
Secondary study parameters/outcome of the study:
Secondary outcome measures are duration of stimulation, cancellation rate, fertilization rate, number of cumulus oocyte complexes obtained, number of mature oocytes obtained, number of top embryos per started cycle, amount of IU recFSH, and clinical pregnancy rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Start rFSH cycle day 2 | Experimental | Drug: Mild stimulation |
| Start rFSH on cycle day 5 | Experimental | Drug: Mild stimulation |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female age < 36 years
- FSH < 12 IU/l
- BMI 18-29 kg/m2
- Regular cycle (25-35 days)
- No major uterine or ovarian abnormalities
Key exclusion criteria (5 listed)
- Oocyte donation
- Medical contra indication for pregnancy or IVF treatment
- Endometriosis ≥ grade 3
- Polycystic Ovarium Syndrome (PCOS)
- Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
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 |
|---|---|---|
| Mild stimulationAlso: Puregon, GanirelixFixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm | Drug | Start rFSH cycle day 2, Start rFSH on cycle day 5 |
Primary outcome
Proportion of Top Embryos Per OPU.
Time frame: 1 year
Proportion of top embryos per ovum pick-up
1 secondary outcome
Number of Cumulus Oocyte Complexes Obtained
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12519847Hohmann FP, Macklon NS, Fauser BC. A randomized comparison of two ovarian stimulation protocols with gonadotropin-releasing hormone (GnRH) antagonist cotreatment for in vitro fertilization commencing recombinant follicle-stimulating hormone on cycle day 2 or 5 with the standard long GnRH agonist protocol. J Clin Endocrinol Metab. 2003 Jan;88(1):166-73. doi: 10.1210/jc.2002-020788.
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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.
Bart C Fauser, Prof, PhD principal investigator
UMC Utrecht
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mild stimulation in people with in Vitro Fertilization and Ovulation Induction, run by UMC Utrecht at 2 sites in 2 countries.
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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Top Embryos Per OPU. (time frame: 1 year). 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 NCT00823472, 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 29 Jan 2019.