Egg BankingPhase 4NCT00785993
Egg-Banking and Ovo-donation
A Phase 4 study testing Vitrification of oocytes for IVF treatment and Protocolary IVF treatment with fresh donor oocytes in people with Egg Banking, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
Egg-banking would considerably simplify the logistics and means by which oocytes could be donated. These banks would make it easier to immediately provide oocytes that would be compatible to the recipient, shortening or even eliminating the problem of long waiting lists. 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
- Egg Banking
- What is being tested?
- Vitrification of oocytes for IVF treatment and Protocolary IVF treatment with fresh donor oocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2008to Oct 2009
- 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
- Receptors
- Women receiving donor oocytes and whose partners without seere pathology of semen.
- BMI < 25
- Donors:
- 18 - 35 years oldaños.
- Normal Response (8-15 follicles)to long protocol of ovarian stimulation with hCG
- Donors with normal menstrual cycles ( 21-35 day duration).
- Donors with Body Mass Index (BMI) between 18-25 Kg/m2
Who cannot join
- Donors with +/= two previous miscarriages'
- Polycystic Ovary Syndrome
- Donors with antecedents of poor embrionary quality not attributed to masculine factor.
- Donors with decline of Estradiol Hormone of more than 10% or Estradiol Hormone plateau.
- Donors with a high response >20 ovocitos and/or levels above 3000pg/mL of Estradiol the day of the administration of Chorionic gonadotropin (hCG.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Egg-Banking in an Ovum-donation Program
Egg-banking would considerably simplify the logistics and means by which oocytes could be donated. These banks would make it easier to immediately provide oocytes that would be compatible to the recipient, shortening or even eliminating the problem of long waiting lists. Egg-banking would also allow the oocytes to be effectively quarantined, drastically diminishing the risk of transmission of infectious diseases in a fashion analogous to semen banks. The most essential prerequisite for a successful egg cryo-banking program is to have an efficient oocyte cryopreservation technology. Recent studies, including our own experience, have indicated that vitrified oocytes preserve intact their potential to fertilize and further develop into competent embryos, giving high clinical results as well as high survival rates. The aim of this study is to evaluate impact of the establishment of an egg-banking in our ovum donation program. Oocyte cryopreservation is carried out by Cryotop method. The study includes oocyte donation cycles conducted with fresh and vitrified oocytes. Recipients are allocated randomly into each group ("fresh vs. vitrified cycles"). Main outcome measures include survival, fertilization, embryo development and clinical outcome.
- Conditions
- Egg Banking
- Being tested
- Vitrification of oocytes for IVF treatment, Protocolary IVF treatment with fresh donor oocytes
- Keywords
- Egg banking, clinical outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrification of oocytes for IVF treatmentOther
Protocolary IVF treatment with fresh donor oocytesOther
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Fresh donor oocytes Receives: Other: Protocolary IVF treatment with fresh donor oocytes |
| Group I | Experimental | vitrified donor oocytes Receives: Other: Vitrification of oocytes for IVF treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the clinical outcome in an ovum donation program conducted with egg-banking.
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 posted5 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Egg BankingStudies 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Investigators
- Ana Cobo, PhD, Principal investigator, Instituto Valenciano de Infertilidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785993
- Sponsor's protocol ID
- 0703-C-017-AC
- Status last verified
- Oct 2009
- First submitted
- 4 Nov 2008
- Last updated
- 2 Oct 2009
- Results posted
- No
Publications
Cobo A, Meseguer M, Remohi J, Pellicer A. Use of cryo-banked oocytes in an ovum donation programme: a prospective, randomized, controlled, clinical trial. Hum Reprod. 2010 Sep;25(9):2239-46. doi: 10.1093/humrep/deq146. Epub 2010 Jun 30.
PubMed 20591872
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Egg-Banking in an Ovum-donation Program
- ClinicalTrials.gov ID
- NCT00785993
- Acronym / sponsor ID
- 0703-C-017-AC
- Conditions
- Egg Banking
- Keywords
- Egg banking, clinical outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 5 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.
Egg-banking would considerably simplify the logistics and means by which oocytes could be donated. These banks would make it easier to immediately provide oocytes that would be compatible to the recipient, shortening or even eliminating the problem of long waiting lists. Egg-banking would also allow the oocytes to be effectively quarantined, drastically diminishing the risk of transmission of infectious diseases in a fashion analogous to semen banks. The most essential prerequisite for a successful egg cryo-banking program is to have an efficient oocyte cryopreservation technology. Recent studies, including our own experience, have indicated that vitrified oocytes preserve intact their potential to fertilize and further develop into competent embryos, giving high clinical results as well as high survival rates. The aim of this study is to evaluate impact of the establishment of an egg-banking in our ovum donation program. Oocyte cryopreservation is carried out by Cryotop method. The study includes oocyte donation cycles conducted with fresh and vitrified oocytes. Recipients are allocated randomly into each group ("fresh vs. vitrified cycles"). Main outcome measures include survival, fertilization, embryo development and clinical outcome.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Protocolary IVF treatment with fresh donor oocytesFresh donor oocytes |
| Group I | Experimental | Other: Vitrification of oocytes for IVF treatmentvitrified donor oocytes |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Receptors
- 18 - 35 years oldaños.
- Normal Response (8-15 follicles)to long protocol of ovarian stimulation with hCG
- Donors with normal menstrual cycles ( 21-35 day duration).
- Donors with Body Mass Index (BMI) between 18-25 Kg/m2
Key exclusion criteria (5 listed)
- Donors with +/= two previous miscarriages'
- Polycystic Ovary Syndrome
- Donors with antecedents of poor embrionary quality not attributed to masculine factor.
- Donors with decline of Estradiol Hormone of more than 10% or Estradiol Hormone plateau.
- Donors with a high response >20 ovocitos and/or levels above 3000pg/mL of Estradiol the day of the administration of Chorionic gonadotropin (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 |
|---|---|---|
| Vitrification of oocytes for IVF treatment | Other | Group I |
| Protocolary IVF treatment with fresh donor oocytes | Other | Control Group |
Primary outcome
To evaluate the clinical outcome in an ovum donation program conducted with egg-banking.
Time frame: 14 days
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 2 Oct 2009.
- Derived from this study: PubMed 20591872Cobo A, Meseguer M, Remohi J, Pellicer A. Use of cryo-banked oocytes in an ovum donation programme: a prospective, randomized, controlled, clinical trial. Hum Reprod. 2010 Sep;25(9):2239-46. doi: 10.1093/humrep/deq146. Epub 2010 Jun 30.
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.
Ana Cobo, PhD principal investigator
Instituto Valenciano de Infertilidad
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 Vitrification of oocytes for IVF treatment and Protocolary IVF treatment with fresh donor oocytes in people with Egg Banking, 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 8 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 2 Oct 2009. 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?
To evaluate the clinical outcome in an ovum donation program conducted with egg-banking. (time frame: 14 days). 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 NCT00785993, 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 2 Oct 2009.