Fertilization in VitroNCT02990949
The Impact of the Timing of Trigger on IVF Success
A study testing Timing of trigger in people with Fertilization in Vitro and Infertility, run by Colorado Center for Reproductive Medicine at 1 site in United States.
Trial summary
The aim of this study is to examine the length of ovarian stimulation with the timing of trigger in an IVF cycle and its potential to impact patient outcomes. Read more about this study
- Who is it for?
- Ages 26 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertilization in Vitro, Infertility, Embryonic Development
- What is being tested?
- Timing of trigger
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 15 Jun 2022
- 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 26 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Planning to move forward with an IVF cycle
- Have met the requirements of being a patient at CCRM Colorado
- AMA: 39-44 years old And/or
- DOR: AMH < 1 \& FSH >10 (age independent)
Who cannot join
- Contraindication for pregnancy
- Have not fulfilled requirements for IVF cycle
- Single gene couple or chromosomal rearrangement
- Severe male factor or testicular surgical sperm removal (need sufficient sperm for ICSI)
- One ovary
- Uterine anomalies
Show all 10Show fewer
- Stage III or IV endometriosis
- Explained recurrent miscarriage
- PCO or PCOS
- Using donor oocyte or gestational carrier
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, 80124
About this study
Official title: The Impact of the Timing of Trigger on IVF Success: Randomized Control Trial
The aim of this study is to examine the length of ovarian stimulation with the timing of trigger in an IVF cycle and its potential to impact patient outcomes.
- Conditions
- Fertilization in Vitro, Infertility, Embryonic Development
- Being tested
- Timing of trigger
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of triggerOther
| Study group | Role | What they receive |
|---|---|---|
| Testing group | Experimental | Timing of trigger at end of ovarian stimulation in an IVF cycle: trigger when 2 follicles reach 18mm, OR 1 follicle reaches 18mm AND 1 follicle is between 16-18mm. Receives: Other: Timing of trigger |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Euploid Embryos: the percentage of euploid embryos produced as analyzed by comprehensive chromosomal screening, of total embryos tested
Measured: 4 weeks after egg retrieval
Secondary outcomes (2)
Egg maturation: the proportion of mature eggs of total number of eggs retrieved
Measured: 1 week after egg retrieval
Live birth outcomes: the incidence of pregnancy resulting in live birth following embryo transfer of embryos produced by this IVF cycle
Measured: 9 months after frozen embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion9 May 2022
- Study completion15 Jun 2022
Why it stopped: Stopped due to lack of enrollement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertilization in VitroStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado Center for Reproductive Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Fertility Laboratories Of Colorado
- Responsible party
- Sponsor
- Investigators
- Mandy Katz-Jaffe, PhD, Study director, CCRM, FLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990949
- Sponsor's protocol ID
- 20160397
- Status last verified
- Oct 2022
- First submitted
- 6 Dec 2016
- Last updated
- 14 Oct 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Timing of Trigger on IVF Success: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02990949
- Acronym / sponsor ID
- 20160397
- Conditions
- Fertilization in Vitro, Infertility, Embryonic Development
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped due to lack of enrollement
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Colorado Center for Reproductive MedicineUniversity, hospital or other
- Collaborators
- Fertility Laboratories Of Colorado
- Study start
- Nov 2016 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 13 Dec 2016 (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.
The aim of this study is to examine the length of ovarian stimulation with the timing of trigger in an IVF cycle and its potential to impact patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testing group | Experimental | Other: Timing of triggerTiming of trigger at end of ovarian stimulation in an IVF cycle: trigger when 2 follicles reach 18mm, OR 1 follicle reaches 18mm AND 1 follicle is between 16-18mm. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 26 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Planning to move forward with an IVF cycle
- Have met the requirements of being a patient at CCRM Colorado
- AMA: 39-44 years old And/or
- DOR: AMH < 1 \& FSH >10 (age independent)
Key exclusion criteria (10 listed)
- Contraindication for pregnancy
- Have not fulfilled requirements for IVF cycle
- Single gene couple or chromosomal rearrangement
- Severe male factor or testicular surgical sperm removal (need sufficient sperm for ICSI)
- One ovary
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 |
|---|---|---|
| Timing of trigger | Other | Testing group |
Primary outcome
Euploid Embryos: the percentage of euploid embryos produced as analyzed by comprehensive chromosomal screening, of total embryos tested
Time frame: 4 weeks after egg retrieval
2 secondary outcomes
Egg maturation: the proportion of mature eggs of total number of eggs retrieved
Time frame: 1 week after egg retrieval
Live birth outcomes: the incidence of pregnancy resulting in live birth following embryo transfer of embryos produced by this IVF cycle
Time frame: 9 months after frozen embryo transfer
Results and safety
The study was stopped early (reason given: Stopped due to lack of enrollement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
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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.
Mandy Katz-Jaffe, PhD study director
CCRM, FLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing of trigger in people with Fertilization in Vitro and Infertility, run by Colorado Center for Reproductive Medicine 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 10 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 14 Oct 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?
The study was stopped early (reason given: Stopped due to lack of enrollement). Results are not available in the source record.
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?
Euploid Embryos: the percentage of euploid embryos produced as analyzed by comprehensive chromosomal screening, of total embryos tested (time frame: 4 weeks after egg retrieval). 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 14 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.