Infertility, FemaleNCT05498350
Randomized Trial Comparing Early "Trigger" Versus Delayed "Trigger" Timing in Cycles of Controlled Ovarian Stimulation.
A study testing Ovulatory trigger timing in people with Infertility, Female, run by Fertility Center of Las Vegas at 1 site in United States.
Trial summary
This randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (COS) for cycles in which all embryos will be cryopreserved ("freeze-all cycles"). Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Ovulatory trigger timing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2022to 30 Nov 2025
- Phase
- Interventional
- 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 18 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult female at least 18 years of age and less than 35 years of age intending to undergo ovarian stimulation for a cycle of IVF with all embryos to be frozen that attain the blastocyst stage.
- Anticipated at least normal ovarian response evidenced by at least 8 antral follicles observed on ultrasound or a serum level of at least 1.5 ng/ml AMH.
- Ability read and understand English sufficiently to obtain informed consent.
- Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study.
Who cannot join
- Any cycle type that would preclude immediate culture to blastocyst stage (e.g. oocyte banking).
- Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fertility center of Las Vegas
Las Vegas, Nevada, 89117
Shironda Anderson, BA, 702-254-1777 ext. 265, Shironda@fertilitycenterlv.com
About this study
This randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (COS) for cycles in which all embryos will be cryopreserved ("freeze-all cycles").
Read the detailed description
This randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (COS) for cycles in which all embryos will be cryopreserved ("freeze-all cycles").
- The early trigger timing will be based on sonographic observation of at least three follicles reaching at least 17mm in diameter.
- The delayed trigger timing will be based on at least three follicles reaching at least 22mm in diameter.
- Conditions
- Infertility, Female
- Being tested
- Ovulatory trigger timing
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovulatory trigger timingProcedure or surgery
Timing of medication to induce final oocyte maturation
| Study group | Role | What they receive |
|---|---|---|
| Early Trigger | Experimental | Not described Receives: Procedure: Ovulatory trigger timing |
| Delayed trigger | Experimental | Not described Receives: Procedure: Ovulatory trigger timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good-quality blastocysts
Number of blastocysts with A or B morphological grade.
Measured: Within 7 days of oocyte retrieval
Delayed blastocyst formation
Proportion of good-quality of blastocysts that formed after day 5.
Measured: Within 7 days of oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start10 Aug 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fertility Center of Las Vegas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Bruce Shapiro M.D., Fertility Center of Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498350
- Sponsor's protocol ID
- FCLV-2022-1
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Early "Trigger" Versus Delayed "Trigger" Timing in Cycles of Controlled Ovarian Stimulation.
- ClinicalTrials.gov ID
- NCT05498350
- Acronym / sponsor ID
- FCLV-2022-1
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fertility Center of Las VegasIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 12 Aug 2022 (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 randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (COS) for cycles in which all embryos will be cryopreserved ("freeze-all cycles").
Detailed description
This randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (COS) for cycles in which all embryos will be cryopreserved ("freeze-all cycles").
- The early trigger timing will be based on sonographic observation of at least three follicles reaching at least 17mm in diameter.
- The delayed trigger timing will be based on at least three follicles reaching at least 22mm in diameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Trigger | Experimental | Procedure: Ovulatory trigger timing |
| Delayed trigger | Experimental | Procedure: Ovulatory trigger timing |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult female at least 18 years of age and less than 35 years of age intending to undergo ovarian stimulation for a cycle of IVF with all embryos to be frozen that attain the blastocyst stage.
- Anticipated at least normal ovarian response evidenced by at least 8 antral follicles observed on ultrasound or a serum level of at least 1.5 ng/ml AMH.
- Ability read and understand English sufficiently to obtain informed consent.
- Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study.
Key exclusion criteria (2 listed)
- Any cycle type that would preclude immediate culture to blastocyst stage (e.g. oocyte banking).
- Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
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 |
|---|---|---|
| Ovulatory trigger timingTiming of medication to induce final oocyte maturation | Procedure or surgery | Delayed trigger, Early Trigger |
Primary outcome
Good-quality blastocysts
Time frame: Within 7 days of oocyte retrieval
Number of blastocysts with A or B morphological grade.
Delayed blastocyst formation
Time frame: Within 7 days of oocyte retrieval
Proportion of good-quality of blastocysts that formed after day 5.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovulatory trigger timing in people with Infertility, Female, run by Fertility Center of Las Vegas 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 4 inclusion and 2 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 12 Aug 2022. 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.
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 Forest Garner, MS (7022541777 ext. 264, Forest@fertilitycenterlv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good-quality blastocysts (time frame: Within 7 days of oocyte retrieval). The study lists 2 primary outcomes in all. 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 12 Aug 2022.