InfertilityNCT00615771
Day of Embryo Transfer for Patients Undergoing In Vitro Fertilization
A study testing Day 3 embryo transfer and Day 2 embryo transfer in people with Infertility, run by Stanford University at 1 site in United States.
Trial summary
We are examining whether pregnancy rates differ based on day of embryo transfer in patients who replace all available embryos after an In vitro Fertilization (IVF) cycle. Patients must be undergoing IVF treatment at Stanford University and patients will not receive compensation for their participation (no medical… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Day 3 embryo transfer and Day 2 embryo transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing fresh IVF cycle at Stanford Fertility Center who plan on replacing all available embryos.
Who cannot join
- Patients that do not meet above criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Embryo Transfer on Day 2 vs. Day 3 After Oocyte Retrieval in Patients Who Plan to Replace All Embryos After an In Vitro Fertilization Cycle
We are examining whether pregnancy rates differ based on day of embryo transfer in patients who replace all available embryos after an In vitro Fertilization (IVF) cycle. Patients must be undergoing IVF treatment at Stanford University and patients will not receive compensation for their participation (no medical costs covered or patient payment for participation).
Read the detailed description
The decision on the number of embryos to transfer after an IVF cycle is based on the number of available embryos, the quality of the embryos, the patient's age, and the goal of limiting multiple gestations. Stanford Fertility Center and most IVF centers examine the embryos on the third day after oocyte (egg) retrieval to select for the best quality embryos to transfer, and depending on quality, the remaining embryos are frozen to be used in the future. Patients with a limited number of embryos, those that plan to replace all available embryos after an IVF cycle, do not need to wait until the third day after oocyte retrieval to select embryos, and may replace the embryos on the second day after the oocyte retrieval. We are examining whether pregnancy rates differ among these patients based on the day of embryo transfer (Day 2 vs. Day3). Patients must be undergoing IVF treatment at Stanford University and patients will not receive compensation for their participation (no medical costs covered or patient payment for participation).
- Conditions
- Infertility
- Being tested
- Day 3 embryo transfer, Day 2 embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day 3 embryo transferProcedure or surgery
Standard of care
Day 2 embryo transferProcedure or surgery
Embryos are transferred 1 day prior to standard of care
| Study group | Role | What they receive |
|---|---|---|
| Day 2 embryo transfer | Experimental | Embryos are transferred 2 days after fertilization. Receives: Procedure: Day 2 embryo transfer |
| Day 3 embryo transfer | Active comparator | Standard of care for women undergoing IVF with a limited number of embryos is to transfer all embryos on Day 3 after fertilization Receives: Procedure: Day 3 embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rates
Measured: 1 year
Secondary outcomes (2)
Live birth rates
Measured: 1 year
Multiple gestation rates
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionMar 2009
- Study completionMar 2009
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 Stanford 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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Bunker Lathi, Stanford University
- Investigators
- Lora K Shahine, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615771
- Sponsor's protocol ID
- SU-01312008-991
- Status last verified
- Jul 2011
- First submitted
- 1 Feb 2008
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryo Transfer on Day 2 vs. Day 3 After Oocyte Retrieval in Patients Who Plan to Replace All Embryos After an In Vitro Fertilization Cycle
- ClinicalTrials.gov ID
- NCT00615771
- Acronym / sponsor ID
- SU-01312008-991
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Feb 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.
We are examining whether pregnancy rates differ based on day of embryo transfer in patients who replace all available embryos after an In vitro Fertilization (IVF) cycle. Patients must be undergoing IVF treatment at Stanford University and patients will not receive compensation for their participation (no medical costs covered or patient payment for participation).
Detailed description
The decision on the number of embryos to transfer after an IVF cycle is based on the number of available embryos, the quality of the embryos, the patient's age, and the goal of limiting multiple gestations. Stanford Fertility Center and most IVF centers examine the embryos on the third day after oocyte (egg) retrieval to select for the best quality embryos to transfer, and depending on quality, the remaining embryos are frozen to be used in the future. Patients with a limited number of embryos, those that plan to replace all available embryos after an IVF cycle, do not need to wait until the third day after oocyte retrieval to select embryos, and may replace the embryos on the second day after the oocyte retrieval. We are examining whether pregnancy rates differ among these patients based on the day of embryo transfer (Day 2 vs. Day3). Patients must be undergoing IVF treatment at Stanford University and patients will not receive compensation for their participation (no medical costs covered or patient payment for participation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day 2 embryo transfer | Experimental | Procedure: Day 2 embryo transferEmbryos are transferred 2 days after fertilization. |
| Day 3 embryo transfer | Active comparator | Procedure: Day 3 embryo transferStandard of care for women undergoing IVF with a limited number of embryos is to transfer all embryos on Day 3 after fertilization |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing fresh IVF cycle at Stanford Fertility Center who plan on replacing all available embryos.
Key exclusion criteria (1 listed)
- Patients that do not meet above criteria.
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 |
|---|---|---|
| Day 3 embryo transferStandard of care | Procedure or surgery | Day 3 embryo transfer |
| Day 2 embryo transferEmbryos are transferred 1 day prior to standard of care | Procedure or surgery | Day 2 embryo transfer |
Primary outcome
Pregnancy rates
Time frame: 1 year
2 secondary outcomes
Live birth rates
Time frame: 1 year
Multiple gestation rates
Time frame: 1 year
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 28 Nov 2016.
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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.
Lora K Shahine principal investigator
Stanford 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 Day 3 embryo transfer and Day 2 embryo transfer in people with Infertility, run by Stanford 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 1 inclusion and 1 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 28 Nov 2016. 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 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?
Pregnancy rates (time frame: 1 year). 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 28 Nov 2016.