InfertilityNCT02026193
IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing
A study testing oocyte vitrification and embryo freezing in people with Infertility, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The chances to achieve pregnancy after retrieving >15 oocytes are not good, probably because of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the investigators prefer to freeze all embryos, and transfer in a thaw cycle. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- oocyte vitrification and embryo freezing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- IVF patients
- ovulation trigger with Decapeptyl 0.2 mg because of ovarian hyper-response: E2 on trigger day .12,000 pmol/l and/or >15 oocytes.
- Normal uterus
Who cannot join
- <20% fertilization rate
Trial locations and contacts
1 site in 1 country.
About this study
The chances to achieve pregnancy after retrieving >15 oocytes are not good, probably because of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle.
The purpose of this study is to compare the outcome of these two approaches.
- Conditions
- Infertility
- Being tested
- oocyte vitrification, embryo freezing
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oocyte vitrificationProcedure or surgery
embryo freezingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| oocyte vitrification | Experimental | All retrieved mature oocytes will be vitrified. Receives: Procedure: oocyte vitrification |
| embryo freezing | Active comparator | All retrieved oocytes will be fertilized, and resulting embryos will be frozen. Receives: Procedure: embryo freezing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Heart Activity 1 Month Post Embryo Transfer
Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer
Measured: 1 month after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahar Kol MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026193
- Sponsor's protocol ID
- RMB-0439-13
- Status last verified
- May 2015
- First submitted
- 30 Dec 2013
- Last updated
- 8 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9.
PubMed 21828116
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing
- ClinicalTrials.gov ID
- NCT02026193
- Acronym / sponsor ID
- RMB-0439-13
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Posted 8 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The chances to achieve pregnancy after retrieving >15 oocytes are not good, probably because of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle.
The purpose of this study is to compare the outcome of these two approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oocyte vitrification | Experimental | Procedure: oocyte vitrificationAll retrieved mature oocytes will be vitrified. |
| embryo freezing | Active comparator | Procedure: embryo freezingAll retrieved oocytes will be fertilized, and resulting embryos will be frozen. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- IVF patients
- ovulation trigger with Decapeptyl 0.2 mg because of ovarian hyper-response: E2 on trigger day .12,000 pmol/l and/or >15 oocytes.
- Normal uterus
Key exclusion criteria (1 listed)
- <20% fertilization rate
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 |
|---|---|---|
| oocyte vitrification | Procedure or surgery | oocyte vitrification |
| embryo freezing | Procedure or surgery | embryo freezing |
Primary outcome
Fetal Heart Activity 1 Month Post Embryo Transfer
Time frame: 1 month after embryo transfer
Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21828116Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9.
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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 oocyte vitrification and embryo freezing in people with Infertility, run by Rambam Health Care Campus 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 3 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 8 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?
Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fetal Heart Activity 1 Month Post Embryo Transfer (time frame: 1 month after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02026193, which also lists 1 linked publication.
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 8 Jun 2015; AzTrials last refreshed its copy on 29 Oct 2026.