Diminished Ovarian ReserveNCT05677828
SMART Protocol vs Antagonist Protocol in IVF
An observational study of Diminished Ovarian Reserve, run by Clinique Ovo at 1 site in Canada.
Trial summary
This retrospective study aims to assess the effect of adding letrozole in patients who have previously undergone an IVF cycle with either an antagonist or short protocol, with patients who have undergone a second cycle of IVF with an antagonist or short protocol without the addition of letrozole. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve
- How many people
- 426 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2022to 31 Jan 2023
- Phase
- Observational
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Study population: This retrospective cohort study will analyze IVF cycles in antagonist and SMART stimulation protocols during the period from 2010 to 2020.
Who may be able to join
- Women between the ages of 20 and 42 inclusively
- Women proceeding with a SMART IVF protocol following an antagonist IVF protocol between 2010 and 2020 (study group) or women proceeding with an antagonist protocol following an antagonist IVF protocol between 2010 and 2020 (control group)
- Delay of 1 year between both IVF cycle
Who cannot join
- Women undergoing fertility preservation
- Oocyte donation IVF cycles
- Diagnosed severe male factor requiring surgical sperm extraction (micro-tese or TESA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Addition of Letrozole in in Vitro Fertilization (IVF) Following a Prior Failed IVF Cycle With an Antagonist or Short Protocol Without Letrozole
This retrospective study aims to assess the effect of adding letrozole in patients who have previously undergone an IVF cycle with either an antagonist or short protocol, with patients who have undergone a second cycle of IVF with an antagonist or short protocol without the addition of letrozole.
Read the detailed description
A limited number of studies suggest that the addition of letrozole to gonadotropins for IVF is associated with an increase in oocyte count, blastocyst count and implantation rate. These differences are presumed to be caused by an increase in intra-ovarian androgens associated with the addition of letrozole.
In patients with reduced ovarian reserve or reduced oocyte quality in the previous cycle, supplementation with of letrozole has the potential to increase oocyte count or oocyte quality, thereby resulting in more transferable blastocysts. The antagonist stimulation protocol with the addition of letrozole is commonly referred to as the SMART protocol (Stimulation with Minimal Adverse effects, Retrieval and Transfer
- Conditions
- Diminished Ovarian Reserve
- Keywords
- IVF, Fertility issues
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Antagonist - SMART | Women who have had a SMART IVF stimulation cycle with Letrozole after a failed antagonist IVF stimulation cycle between 2010 and 2020. | |
| Antagonist - Antagonist | Women who have had an antagonist stimulation IVF cycle after a previously failed antagonist IVF stimulation cycle between 2010 and 2020. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of utilizable blastocysts obtained
Comparing 2 different IVF cycle protocols in terms of total dose of gonadotropins used
Measured: approximately 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start15 Feb 2022
- Primary completion12 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ReserveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Hemmings, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677828
- Sponsor's protocol ID
- CCER 21-22 - 21
- Status last verified
- Mar 2023
- First submitted
- 22 Dec 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Addition of Letrozole in in Vitro Fertilization (IVF) Following a Prior Failed IVF Cycle With an Antagonist or Short Protocol Without Letrozole
- ClinicalTrials.gov ID
- NCT05677828
- Acronym / sponsor ID
- CCER 21-22 - 21
- Conditions
- Diminished Ovarian Reserve
- Keywords
- IVF, Fertility issues
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 10 Jan 2023 (actual)
- 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 retrospective study aims to assess the effect of adding letrozole in patients who have previously undergone an IVF cycle with either an antagonist or short protocol, with patients who have undergone a second cycle of IVF with an antagonist or short protocol without the addition of letrozole.
Detailed description
A limited number of studies suggest that the addition of letrozole to gonadotropins for IVF is associated with an increase in oocyte count, blastocyst count and implantation rate. These differences are presumed to be caused by an increase in intra-ovarian androgens associated with the addition of letrozole.
In patients with reduced ovarian reserve or reduced oocyte quality in the previous cycle, supplementation with of letrozole has the potential to increase oocyte count or oocyte quality, thereby resulting in more transferable blastocysts. The antagonist stimulation protocol with the addition of letrozole is commonly referred to as the SMART protocol (Stimulation with Minimal Adverse effects, Retrieval and Transfer
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antagonist - SMART | – | –Women who have had a SMART IVF stimulation cycle with Letrozole after a failed antagonist IVF stimulation cycle between 2010 and 2020. |
| Antagonist - Antagonist | – | –Women who have had an antagonist stimulation IVF cycle after a previously failed antagonist IVF stimulation cycle between 2010 and 2020. |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This retrospective cohort study will analyze IVF cycles in antagonist and SMART stimulation protocols during the period from 2010 to 2020.
Key inclusion criteria (3 listed)
- Women between the ages of 20 and 42 inclusively
- Women proceeding with a SMART IVF protocol following an antagonist IVF protocol between 2010 and 2020 (study group) or women proceeding with an antagonist protocol following an antagonist IVF protocol between 2010 and 2020 (control group)
- Delay of 1 year between both IVF cycle
Key exclusion criteria (3 listed)
- Women undergoing fertility preservation
- Oocyte donation IVF cycles
- Diagnosed severe male factor requiring surgical sperm extraction (micro-tese or TESA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of utilizable blastocysts obtained
Time frame: approximately 20 days
Comparing 2 different IVF cycle protocols in terms of total dose of gonadotropins used
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 29 Mar 2023.
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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.
Robert Hemmings, MD principal investigator
Clinique Ovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diminished Ovarian Reserve, run by Clinique Ovo at 1 site in Canada.
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 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: finished, as of the sponsor's last update on 29 Mar 2023. 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 Canada. 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.
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?
Number of utilizable blastocysts obtained (time frame: approximately 20 days). 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 29 Mar 2023.