InfertilityPhase 4NCT00977821
Embryo Developmental Capacity After Egg Banking in an Ovum Donation Program
A Phase 4 study testing IVF and Oocyte Vitrification in people with Infertility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
For an efficient "egg banking" system, an equally efficient cryopreservation strategy that ensures the viability of the oocytes is required. Very recently, improved and new methods are yielding satisfactory results. In particular, vitrification is providing excellent results for both survival and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- IVF and Oocyte Vitrification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2009to May 2014
- Phase
- Phase 4
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 year old
- Normal response (8-15 follicles) to long protocol of ovarian stimulation with hCG
- Donors with normal menstrual cycles (21-35 day duration)
- Donors with BMI between 18-25 Kg/m2
Who cannot join
- Donors with two or more previous miscarriages
- Polycystic ovary syndrome
- Donors with antecedents of poor embrionary quality not attributed to masculine factor
- Donors with drop of estradiol of more than 10% or estradiol plateau.
- Donors with a high response>20 oocytes and or levels above 3000pg/ml of estradiol the day of the administration of chorionic gonadotrophin (hCG)
Trial locations and contacts
1 site in 1 country.
About this study
For an efficient "egg banking" system, an equally efficient cryopreservation strategy that ensures the viability of the oocytes is required. Very recently, improved and new methods are yielding satisfactory results. In particular, vitrification is providing excellent results for both survival and clinical outcomes. However, to evaluate the over all out come there are other parameters to be considered. In this sense, capacity development of embryos generated after oocyte vitrification is a major factor when assessing the viability of vitrified oocytes. Accordingly, the evaluation of the capacity of vitrified oocytes to reach the blastocyst stage will be highly valuable to fully assess the effectiveness of the "egg banking" and its contribution to ovum donation programs.
The aim of this study is to evaluate the developmental capacity of vitrified oocytes by their ability to reach the blastocyst stage. The study includes oocyte donation cycles conducted with vitrified versus fresh oocytes.
- Conditions
- Infertility
- Being tested
- IVF, Oocyte Vitrification
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVFOther
Oocyte VitrificationOther
| Study group | Role | What they receive |
|---|---|---|
| fresh | Active comparator | Embryo transfer with fresh oocytes Receives: Other: IVF |
| Frozen | Experimental | Embryo transfer with vitrified oocytes Receives: Other: Oocyte Vitrification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean outcome measures will be survival, fertilization and blastocyst rates and clinical outcome.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2014
- Study completionMay 2014
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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 625 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Simon, Instituto Valenciano de Infertilidad, IVI VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977821
- Sponsor's protocol ID
- 0901-F-054-CS
- Status last verified
- Apr 2015
- First submitted
- 15 Sep 2009
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryo Developmental Capacity After Egg Banking in an Ovum Donation Program
- ClinicalTrials.gov ID
- NCT00977821
- Acronym / sponsor ID
- 0901-F-054-CS
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 625 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 Sep 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.
For an efficient "egg banking" system, an equally efficient cryopreservation strategy that ensures the viability of the oocytes is required. Very recently, improved and new methods are yielding satisfactory results. In particular, vitrification is providing excellent results for both survival and clinical outcomes. However, to evaluate the over all out come there are other parameters to be considered. In this sense, capacity development of embryos generated after oocyte vitrification is a major factor when assessing the viability of vitrified oocytes. Accordingly, the evaluation of the capacity of vitrified oocytes to reach the blastocyst stage will be highly valuable to fully assess the effectiveness of the "egg banking" and its contribution to ovum donation programs.
The aim of this study is to evaluate the developmental capacity of vitrified oocytes by their ability to reach the blastocyst stage. The study includes oocyte donation cycles conducted with vitrified versus fresh oocytes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fresh | Active comparator | Other: IVFEmbryo transfer with fresh oocytes |
| Frozen | Experimental | Other: Oocyte VitrificationEmbryo transfer with vitrified oocytes |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-35 year old
- Normal response (8-15 follicles) to long protocol of ovarian stimulation with hCG
- Donors with normal menstrual cycles (21-35 day duration)
- Donors with BMI between 18-25 Kg/m2
Key exclusion criteria (5 listed)
- Donors with two or more previous miscarriages
- Polycystic ovary syndrome
- Donors with antecedents of poor embrionary quality not attributed to masculine factor
- Donors with drop of estradiol of more than 10% or estradiol plateau.
- Donors with a high response>20 oocytes and or levels above 3000pg/ml of estradiol the day of the administration of chorionic gonadotrophin (hCG)
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 |
|---|---|---|
| IVF | Other | fresh |
| Oocyte Vitrification | Other | Frozen |
Primary outcome
Mean outcome measures will be survival, fertilization and blastocyst rates and clinical outcome.
Time frame: 10 months
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 22 Apr 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 Phase 4 study testing IVF and Oocyte Vitrification in people with Infertility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
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 5 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 22 Apr 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean outcome measures will be survival, fertilization and blastocyst rates and clinical outcome. (time frame: 10 months). 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 22 Apr 2015.