Fertilization in VitroNCT00608010
Day 3 Embryo Cryopreservation: Metabolic and Viability Analysis
A study testing Vitrification and Slow freezing in people with Fertilization in Vitro and Preservation of Supernumerary Embryos, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
Embryo preservation through freezing plays a significant role in human assisted reproduction. It provides an opportunity for patients to have more than one attempt following an ovarian stimulation cycle, thereby decreasing the exposure of patients to exogenous gonadotrophins and improving cumulative pregnancy rates. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fertilization in Vitro, Preservation of Supernumerary Embryos
- What is being tested?
- Vitrification and Slow freezing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2006to Jan 2007
- 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
- ICSI with own gametes
- Couples who did not wish to cryopreserve their excess embryos for possible transfer in a future cyle
- Donating excess embryos for research purposes
Who cannot join
- Embryos derived from surgically retrieved spermatozoa
- Blastocysts
- Embryos of low quality (Grade 3 or 4 according to Hardarson)
Trial locations and contacts
1 site in 1 country.
About this study
Embryo preservation through freezing plays a significant role in human assisted reproduction. It provides an opportunity for patients to have more than one attempt following an ovarian stimulation cycle, thereby decreasing the exposure of patients to exogenous gonadotrophins and improving cumulative pregnancy rates. The purpose of this study is to compare effectiveness of two different freezing methods.
- Being tested
- Vitrification, Slow freezing
- Keywords
- Preservation of supernumerary embryos in an IVF program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrificationProcedure or surgery
Embryos were vitrified according to a previously described technique
Slow freezingProcedure or surgery
Embryos were frozen with slow freezing technique
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Vitrification Receives: Procedure: Vitrification |
| 2 | Active comparator | Slow freezing Receives: Procedure: Slow freezing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst development rate
Measured: 3 days after thawing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startOct 2006
- Primary completionJan 2007
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 Fertilization in VitroStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- V.K.V. American Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Investigators
- Basak Balaban, BSc, Principal investigator, American Hospital of Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608010
- Sponsor's protocol ID
- AH-ART-06/13
- Status last verified
- Jan 2008
- First submitted
- 22 Jan 2008
- Last updated
- 6 Feb 2008
- Results posted
- No
Publications
Balaban B, Urman B, Ata B, Isiklar A, Larman MG, Hamilton R, Gardner DK. A randomized controlled study of human Day 3 embryo cryopreservation by slow freezing or vitrification: vitrification is associated with higher survival, metabolism and blastocyst formation. Hum Reprod. 2008 Sep;23(9):1976-82. doi: 10.1093/humrep/den222. Epub 2008 Jun 10.
PubMed 18544577
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day 3 Embryo Cryopreservation: Metabolic and Viability Analysis
- ClinicalTrials.gov ID
- NCT00608010
- Acronym / sponsor ID
- AH-ART-06/13
- Keywords
- Preservation of supernumerary embryos in an IVF program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- V.K.V. American Hospital, IstanbulUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jan 2007 (actual)
- First posted
- 6 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.
Embryo preservation through freezing plays a significant role in human assisted reproduction. It provides an opportunity for patients to have more than one attempt following an ovarian stimulation cycle, thereby decreasing the exposure of patients to exogenous gonadotrophins and improving cumulative pregnancy rates. The purpose of this study is to compare effectiveness of two different freezing methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: VitrificationVitrification |
| 2 | Active comparator | Procedure: Slow freezingSlow freezing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICSI with own gametes
- Couples who did not wish to cryopreserve their excess embryos for possible transfer in a future cyle
- Donating excess embryos for research purposes
Key exclusion criteria (3 listed)
- Embryos derived from surgically retrieved spermatozoa
- Blastocysts
- Embryos of low quality (Grade 3 or 4 according to Hardarson)
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 |
|---|---|---|
| VitrificationEmbryos were vitrified according to a previously described technique | Procedure or surgery | 1 |
| Slow freezingEmbryos were frozen with slow freezing technique | Procedure or surgery | 2 |
Primary outcome
Blastocyst development rate
Time frame: 3 days after thawing
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 6 Feb 2008.
- Derived from this study: PubMed 18544577Balaban B, Urman B, Ata B, Isiklar A, Larman MG, Hamilton R, Gardner DK. A randomized controlled study of human Day 3 embryo cryopreservation by slow freezing or vitrification: vitrification is associated with higher survival, metabolism and blastocyst formation. Hum Reprod. 2008 Sep;23(9):1976-82. doi: 10.1093/humrep/den222. Epub 2008 Jun 10.
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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.
Basak Balaban, BSc principal investigator
American Hospital of Istanbul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrification and Slow freezing in people with Fertilization in Vitro and Preservation of Supernumerary Embryos, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
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 3 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 6 Feb 2008. 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 Turkey (Türkiye). 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?
Blastocyst development rate (time frame: 3 days after thawing). 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 NCT00608010, 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 6 Feb 2008.