InfertilityNCT00788619
Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization (IVF)
A study testing Transfer of embryos on day 3 or day 5 after fertilization. and Day 5 transfer in people with Infertility, run by Johns Hopkins University at 1 site in United States.
Trial summary
Improvements in In-Vitro Fertilization (IVF) outcomes have largely been due to the generation of excess embryos allowing for multiple embryo transfer. Unfortunately this has also increased the risk of multiple pregnancy with associated maternal and neonatal morbidity and mortality. Read more about this study
- Who is it for?
- Ages 21 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Transfer of embryos on day 3 or day 5 after fertilization. and Day 5 transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Oct 2009
- 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 21 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 21-37
- Female
- Less than two previous unsuccessful IVF cycles
Who cannot join
- Day 3 FSH >9.9
- Fewer than 8 mature oocytes retrieved
- Fewer than 8 normally fertilized embryos on day 2 after fertilization
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Fertility Center
Lutherville, Maryland, 21093
About this study
Official title: Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization
Improvements in In-Vitro Fertilization (IVF) outcomes have largely been due to the generation of excess embryos allowing for multiple embryo transfer. Unfortunately this has also increased the risk of multiple pregnancy with associated maternal and neonatal morbidity and mortality. The investigators believe that the concentration of nitric oxide metabolites measured in the culture medium from the first day of culture can identify the best quality embryos allowing us to transfer a limited number of embryos without compromising the optimum chance for pregnancy.
- Conditions
- Infertility
- Being tested
- Transfer of embryos on day 3 or day 5 after fertilization., Day 5 transfer
- Keywords
- Infertility, Assisted reproductive technology, Nitric oxide
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfer of embryos on day 3 or day 5 after fertilization.Procedure or surgery
Subjects will be allocated at random to the two arms. Group 1 will have two embryos transferred on day 3 based on nitric oxide concentration. Group 2 will have two embryos transferred on day 5 based on morphologic criteria.
Day 5 transferProcedure or surgery
Subjects will have embryo transfer on day 5 after fertilization. Selection of embryos to transfer will be based on morphologic criteria.
| Study group | Role | What they receive |
|---|---|---|
| Day 3 transfer | Active comparator | Subjects in this arm will have two embryos transferred three days after fertilization. Embryos will be selected based on the concentration of nitric oxide metabolites in the culture medium. Receives: Procedure: Transfer of embryos on day 3 or day 5 after fertilization. |
| Day 5 transfer | Active comparator | Subjects will have two embryos transferred on day 5 after fertilization with selection of embryos based on morphologic criteria. Receives: Procedure: Day 5 transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with viable pregnancy one month after embryo transfer
Measured: 1 month
Secondary outcomes (1)
Percentage of subjects with > 2 viable embryos one month after embryo transfer
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: difficulty with recruitment
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.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa A Kolp, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788619
- Sponsor's protocol ID
- NA_00013752
- Status last verified
- Dec 2017
- First submitted
- 10 Nov 2008
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization
- ClinicalTrials.gov ID
- NCT00788619
- Acronym / sponsor ID
- NA_00013752
- Conditions
- Infertility
- Keywords
- Infertility, Assisted reproductive technology, Nitric oxide
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty with recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Nov 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.
Improvements in In-Vitro Fertilization (IVF) outcomes have largely been due to the generation of excess embryos allowing for multiple embryo transfer. Unfortunately this has also increased the risk of multiple pregnancy with associated maternal and neonatal morbidity and mortality. The investigators believe that the concentration of nitric oxide metabolites measured in the culture medium from the first day of culture can identify the best quality embryos allowing us to transfer a limited number of embryos without compromising the optimum chance for pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day 3 transfer | Active comparator | Procedure: Transfer of embryos on day 3 or day 5 after fertilization.Subjects in this arm will have two embryos transferred three days after fertilization. Embryos will be selected based on the concentration of nitric oxide metabolites in the culture medium. |
| Day 5 transfer | Active comparator | Procedure: Day 5 transferSubjects will have two embryos transferred on day 5 after fertilization with selection of embryos based on morphologic criteria. |
Who may qualify
- Ages
- 21 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 21-37
- Female
- Less than two previous unsuccessful IVF cycles
Key exclusion criteria (3 listed)
- Day 3 FSH >9.9
- Fewer than 8 mature oocytes retrieved
- Fewer than 8 normally fertilized embryos on day 2 after fertilization
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 |
|---|---|---|
| Transfer of embryos on day 3 or day 5 after fertilization.Subjects will be allocated at random to the two arms. Group 1 will have two embryos transferred on day 3 based on nitric oxide concentration. Group 2 will have two embryos transferred on day 5 based on morphologic criteria. | Procedure or surgery | Day 3 transfer |
| Day 5 transferSubjects will have embryo transfer on day 5 after fertilization. Selection of embryos to transfer will be based on morphologic criteria. | Procedure or surgery | Day 5 transfer |
Primary outcome
Percentage of subjects with viable pregnancy one month after embryo transfer
Time frame: 1 month
1 secondary outcome
Percentage of subjects with > 2 viable embryos one month after embryo transfer
Time frame: 1 month
Results and safety
The study was stopped early (reason given: difficulty with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
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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.
Lisa A Kolp, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfer of embryos on day 3 or day 5 after fertilization. and Day 5 transfer in people with Infertility, run by Johns Hopkins University 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 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: stopped early, as of the sponsor's last update on 11 Dec 2017. 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: difficulty with recruitment). 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?
Percentage of subjects with viable pregnancy one month after embryo transfer (time frame: 1 month). 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 11 Dec 2017.