InfertilityNCT01040247
Optimal Timing For Embryo Transfer For Low Responder Patients
A study testing Embryo Transfer in people with Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Women undergoing in vitro fertilization (IVF) therapy, who are low responder and agree to enter the trial will be randomized to a study group, for whom embryo transfer will be done on the same day as oocyte aspiration and fertilization; and a control group for whom embryo transfer will be performed 48 to 72 hours… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Embryo Transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to Mar 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing IVF
- Number of mature oocytes equal to or lesser than the maximum number of embryos intended for transfer
Who cannot join
- Patient nor consenting
Trial locations and contacts
1 site in 1 country.
About this study
Women undergoing in vitro fertilization (IVF) therapy, who are low responder and agree to enter the trial will be randomized to a study group, for whom embryo transfer will be done on the same day as oocyte aspiration and fertilization; and a control group for whom embryo transfer will be performed 48 to 72 hours later, as is the current accepted practice.
- Conditions
- Infertility
- Being tested
- Embryo Transfer
- Keywords
- Infertility, Low Responder, IVF, 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.
Embryo TransferOther
In the study group embryo transfer will be performed on the day of oocyte aspiration and fertilization while in the control group it will be done 2 or 3 days later as is common practice.
| Study group | Role | What they receive |
|---|---|---|
| Day 0 Embryo Transfer | Experimental | Embryo transfer will be performed on the same day as oocyte aspiration and fertilization Receives: Other: Embryo Transfer |
| Day 2,3 Embryo Transfer | Active comparator | Embryo Transfer will be performed 2 or 3 days after oocyte aspiration and fertilization Receives: Other: Embryo Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Difficulty in recruiting patients
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.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Weiss, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040247
- Sponsor's protocol ID
- 0027-09-EMC
- Status last verified
- Jun 2015
- First submitted
- 28 Dec 2009
- Last updated
- 23 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing For Embryo Transfer For Low Responder Patients
- ClinicalTrials.gov ID
- NCT01040247
- Acronym / sponsor ID
- 0027-09-EMC
- Conditions
- Infertility
- Keywords
- Infertility, Low Responder, IVF, Embryo Transfer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting patients
- Enrolment
- 20 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 29 Dec 2009 (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.
Women undergoing in vitro fertilization (IVF) therapy, who are low responder and agree to enter the trial will be randomized to a study group, for whom embryo transfer will be done on the same day as oocyte aspiration and fertilization; and a control group for whom embryo transfer will be performed 48 to 72 hours later, as is the current accepted practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day 0 Embryo Transfer | Experimental | Other: Embryo TransferEmbryo transfer will be performed on the same day as oocyte aspiration and fertilization |
| Day 2,3 Embryo Transfer | Active comparator | Other: Embryo TransferEmbryo Transfer will be performed 2 or 3 days after oocyte aspiration and fertilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergoing IVF
- Number of mature oocytes equal to or lesser than the maximum number of embryos intended for transfer
Key exclusion criteria (1 listed)
- Patient nor consenting
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 |
|---|---|---|
| Embryo TransferIn the study group embryo transfer will be performed on the day of oocyte aspiration and fertilization while in the control group it will be done 2 or 3 days later as is common practice. | Other | Day 0 Embryo Transfer, Day 2,3 Embryo Transfer |
Primary outcome
Pregnancy
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embryo Transfer in people with Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 2 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: stopped early, as of the sponsor's last update on 23 Jun 2015. 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 Israel. 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 in recruiting patients). 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?
Pregnancy (time frame: 14 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 23 Jun 2015.