InfertilityPhase 4Cost-LessNCT00804960
Does Letrozole Improve the Outcomes and/or Reduce the Cost of IVF-ET Cycles?
A Phase 4 study testing Letrozole and Std IVF Protocol in people with Infertility, run by Center for Human Reproduction at 1 site in United States.
Trial summary
This research is being done to determine whether the success rate of in vitro fertilization treatment can be improved, while lowering the cost incurred from infertility medications using a pill called letrozole. Read more about this study
- Who is it for?
- Ages 21 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Letrozole and Std IVF Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Apr 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 21 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal Ovarian Function
- Normal uterus
Who cannot join
- Age 40 and above
- Diminished ovarian reserve (based on markers and/or previous poor response)
- Previous oophorectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Human Reproduction
New York, New York, 10021
About this study
Official title: Controlled Ovarian Stimulation With Letrozole Supplementation
This research is being done to determine whether the success rate of in vitro fertilization treatment can be improved, while lowering the cost incurred from infertility medications using a pill called letrozole.
Read the detailed description
Specific Aim:
- To determine whether addition of letrozole to gonadotropins would reduce the amount of gonadotropins used in an IVF-ET cycle, thereby reducing the cost.
- To determine whether letrozole improves IVF-ET success compared to standard ovarian stimulation protocols.
Null Hypothesis: Use of Letrozole for ovulation induction in IVF is not less expensive than the standard therapy by a clinically relevant amount.
Alternative Hypothesis: Use of Letrozole for ovulation induction in IVF is better than the standard therapy by a clinically relevant amount.
Protocol:
Infertile women <40 years of age with age-appropriate ovarian reserve (as determined by day2/3 E2, FSH, and AMH) will be randomized between two protocols: one with letrozole and one with standard ovulation induction.
In both groups, serum FSH will be measured each time a sample is obtained for estradiol. Sera will be frozen for further batch assay.
Number of embryos to be transferred will be decided following the ASRM guidelines. The day of embryo transfer (D-3 vs D-5) will be based on the number and quality of embryos as per established clinical criteria.
Power Considerations
A review of 1473 cycles of patients less than 40 years old over the last 6 years (2002 - 2008) revealed average cost per cycle to be $3,152 +/- 1685(SD).
For the purpose of this power analysis we consider a 20% decrease in medication cost to be clinically significant. Thus a decrease from $ 3152.83 to $ 2522.26 will be considered clinically significant (20% decrease). For an alpha of 0.05 and a power of 80% for a two tailed test 113 patients will need to complete each arm.
Allowing for 10% drop-out we will attempt to randomize 125 patients to each arm of the study.
- Conditions
- Infertility
- Being tested
- Letrozole, Std IVF Protocol
- Keywords
- Cost of Infertility Treatment, Ovulation Induction, Letrozole, In Vitro Fertilization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara
- Letrozole 5 mg starting on cycle day 2, which will be continued until the day of trigger. Recombinant FSH at doses 100-225 units, as determined by BMI, AFC, age, and ovarian reserve markers will be added on cycle day 4. The dose will be adjusted based on the response. An antagonist will be administered once the lead follicle reaches 14-mm in diameter or when estradiol level reaches 250 pg/mL. Oocyte maturation will be triggered by 20 iu of leuprolide acetate.
Std IVF ProtocolDrug
Also called Ovulation induction with Human Menopausal gonoadotropins
- Long protocol with luteal phase GnRHa suppression with gonadotropin dose at 200-450 IU. Oocyte maturation will be triggered by 250 micg of ovidrel.
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | 1) Letrozole/ Recombinant FSH Receives: Drug: Letrozole |
| Standard IVF | Active comparator | luteal phase GnRHa suppression/gonadotropin Receives: Drug: Std IVF Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of Treatment
Measured: 4 weeks
Secondary outcomes (3)
Pregnancy and implantation rates
Measured: 4 weeks
Incidence of Ovarian Hyper stimulation Syndrome
Measured: 4 weeks
Multiple Birth Rate
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2009 (estimated)
- Study completionApr 2010 (estimated)
Why it stopped: lack of recruitment at this site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Human Reproduction
- Sponsor type
- University, hospital or other
- Investigators
- David Barad, MD. MS, Study director, CHRKutluk Oktay, MD, Principal investigator, CHR/ New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804960
- Sponsor's protocol ID
- CHR #5/17/08-2
- Acronym
- Cost-Less
- Status last verified
- Jun 2015
- First submitted
- 5 Dec 2008
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Ovarian Stimulation With Letrozole Supplementation
- ClinicalTrials.gov ID
- NCT00804960
- Acronym / sponsor ID
- Cost-Less / CHR #5/17/08-2
- Conditions
- Infertility
- Keywords
- Cost of Infertility Treatment, Ovulation Induction, Letrozole, In Vitro Fertilization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of recruitment at this site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Center for Human ReproductionUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 9 Dec 2008 (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.
This research is being done to determine whether the success rate of in vitro fertilization treatment can be improved, while lowering the cost incurred from infertility medications using a pill called letrozole.
Detailed description
Specific Aim:
- To determine whether addition of letrozole to gonadotropins would reduce the amount of gonadotropins used in an IVF-ET cycle, thereby reducing the cost.
- To determine whether letrozole improves IVF-ET success compared to standard ovarian stimulation protocols.
Null Hypothesis: Use of Letrozole for ovulation induction in IVF is not less expensive than the standard therapy by a clinically relevant amount.
Alternative Hypothesis: Use of Letrozole for ovulation induction in IVF is better than the standard therapy by a clinically relevant amount.
Protocol:
Infertile women <40 years of age with age-appropriate ovarian reserve (as determined by day2/3 E2, FSH, and AMH) will be randomized between two protocols: one with letrozole and one with standard ovulation induction.
In both groups, serum FSH will be measured each time a sample is obtained for estradiol. Sera will be frozen for further batch assay.
Number of embryos to be transferred will be decided following the ASRM guidelines. The day of embryo transfer (D-3 vs D-5) will be based on the number and quality of embryos as per established clinical criteria.
Power Considerations
A review of 1473 cycles of patients less than 40 years old over the last 6 years (2002 - 2008) revealed average cost per cycle to be $3,152 +/- 1685(SD).
For the purpose of this power analysis we consider a 20% decrease in medication cost to be clinically significant. Thus a decrease from $ 3152.83 to $ 2522.26 will be considered clinically significant (20% decrease). For an alpha of 0.05 and a power of 80% for a two tailed test 113 patients will need to complete each arm.
Allowing for 10% drop-out we will attempt to randomize 125 patients to each arm of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: Letrozole1) Letrozole/ Recombinant FSH |
| Standard IVF | Active comparator | Drug: Std IVF Protocolluteal phase GnRHa suppression/gonadotropin |
Who may qualify
- Ages
- 21 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal Ovarian Function
- Normal uterus
Key exclusion criteria (3 listed)
- Age 40 and above
- Diminished ovarian reserve (based on markers and/or previous poor response)
- Previous oophorectomy
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 |
|---|---|---|
| LetrozoleAlso: Femara1) Letrozole 5 mg starting on cycle day 2, which will be continued until the day of trigger. Recombinant FSH at doses 100-225 units, as determined by BMI, AFC, age, and ovarian reserve markers will be added on cycle day 4. The dose will be adjusted based on the response. An antagonist will be administered once the lead follicle reaches 14-mm in diameter or when estradiol level reaches 250 pg/mL. Oocyte maturation will be triggered by 20 iu of leuprolide acetate. | Drug | Letrozole |
| Std IVF ProtocolAlso: Ovulation induction with Human Menopausal gonoadotropins2) Long protocol with luteal phase GnRHa suppression with gonadotropin dose at 200-450 IU. Oocyte maturation will be triggered by 250 micg of ovidrel. | Drug | Standard IVF |
Primary outcome
Cost of Treatment
Time frame: 4 weeks
3 secondary outcomes
Pregnancy and implantation rates
Time frame: 4 weeks
Incidence of Ovarian Hyper stimulation Syndrome
Time frame: 4 weeks
Multiple Birth Rate
Time frame: 10 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
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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.
David Barad, MD. MS study director
CHR
Kutluk Oktay, MD principal investigator
CHR/ New York Medical College
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 Letrozole and Std IVF Protocol in people with Infertility, run by Center for Human Reproduction at 1 site in United States.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 25 Jun 2015. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cost of Treatment (time frame: 4 weeks). 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 25 Jun 2015.