CryopreservationNCT00521443
Cryosurvival of Embryos From Dysmorphic Oocytes
An observational study of Cryopreservation and Blastocyst, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
Various morphological abnormalities of human oocytes were reported to detrimentally affect embryo development. We observed development of frozen thawed embryos derived from oocytes with normal or abnormal morphological features to the blastocyst stage. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cryopreservation, Blastocyst
- What is being tested?
- Cryopreservation, thawing and blastocyst culture
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 45 years
- Women only
- Adult
Who may be able to join
- Human embryos derived from morphologically normal or abnormal mature oocytes that fertilized normally by microinjection procedure.
- Embryos were obtained from couples who refused to freeze their supernumerary embryos after fresh embryo transfer in an assisted reproduction treatment cycle.
Who cannot join
- Embryos obtained after microinjection to immature oocytes taht were in vitro matured in culture.
- Embryos obtained from abnormally fertilized zygotes.
Trial locations and contacts
1 site in 1 country.
About this study
Various morphological abnormalities of human oocytes were reported to detrimentally affect embryo development. We observed development of frozen thawed embryos derived from oocytes with normal or abnormal morphological features to the blastocyst stage. Cytoplasmic abnormalities of the oocytes were found to negatively affect cryosurvival potential of the embryos.
- Conditions
- Cryopreservation, Blastocyst
- Being tested
- Cryopreservation, thawing and blastocyst culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryopreservation, thawing and blastocyst cultureProcedure or surgery
Good quality human embryos were frozen - thawed and cultured to the blastocyst stage.
| Study group | Role | What they receive |
|---|---|---|
| Normal | Embryos derived from morphologically normal MII oocytes Receives: Procedure: Cryopreservation, thawing and blastocyst culture | |
| Irregular Shapes | Embryos derived from irregularly shaped oocytes. Receives: Procedure: Cryopreservation, thawing and blastocyst culture | |
| Large PVS | Embryos derived from oocytes with large perivitelline space. Receives: Procedure: Cryopreservation, thawing and blastocyst culture | |
| Dark Zona | Embryos derived from oocytes with dark zona pellucida Receives: Procedure: Cryopreservation, thawing and blastocyst culture | |
| Dark cytoplasm | Embryos derived from oocytes with dark cytoplasm Receives: Procedure: Cryopreservation, thawing and blastocyst culture | |
| Vacuolar cytoplasm | Embryos derived from oocytes with vacuolated cytoplasm Receives: Procedure: Cryopreservation, thawing and blastocyst culture | |
| Central granulation | Embryos derived from oocytes with centrally granulated cytoplasm Receives: Procedure: Cryopreservation, thawing and blastocyst culture | |
| Double extra | Embryos derived from oocytes with double extracytoplasmic abnormalities Receives: Procedure: Cryopreservation, thawing and blastocyst culture | |
| Double combined | Embryos derived from oocytes with any combination of one extracytoplasmic and one cytoplasmic anomaly Receives: Procedure: Cryopreservation, thawing and blastocyst culture | |
| Double cytoplasmic | Embryos derived from oocytes with any two cytoplasmic anomalies Receives: Procedure: Cryopreservation, thawing and blastocyst culture | |
| Triple extra | Embryos derived from oocytes with triple extracytoplasmic anomaly Receives: Procedure: Cryopreservation, thawing and blastocyst culture | |
| Triple combined | Embryos derived from oocytes with triple combined anomalies Receives: Procedure: Cryopreservation, thawing and blastocyst culture |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
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 CryopreservationStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- V.K.V. American Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Investigators
- Basak Balaban, B.Sc., Study director, Assisted Reproduction Unit of the VKV American Hospital of Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521443
- Sponsor's protocol ID
- AH-05/04
- Status last verified
- Aug 2007
- First submitted
- 24 Aug 2007
- Last updated
- 27 Aug 2007
- Results posted
- No
Publications
Balaban B, Ata B, Isiklar A, Yakin K, Urman B. Severe cytoplasmic abnormalities of the oocyte decrease cryosurvival and subsequent embryonic development of cryopreserved embryos. Hum Reprod. 2008 Aug;23(8):1778-85. doi: 10.1093/humrep/den127. Epub 2008 May 12.
PubMed 18477573
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryosurvival of Embryos From Dysmorphic Oocytes
- ClinicalTrials.gov ID
- NCT00521443
- Acronym / sponsor ID
- AH-05/04
- Conditions
- Cryopreservation, Blastocyst
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- V.K.V. American Hospital, IstanbulUniversity, hospital or other
- First posted
- 27 Aug 2007 (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.
Various morphological abnormalities of human oocytes were reported to detrimentally affect embryo development. We observed development of frozen thawed embryos derived from oocytes with normal or abnormal morphological features to the blastocyst stage. Cytoplasmic abnormalities of the oocytes were found to negatively affect cryosurvival potential of the embryos.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Procedure: Cryopreservation, thawing and blastocyst cultureEmbryos derived from morphologically normal MII oocytes |
| Irregular Shapes | – | Procedure: Cryopreservation, thawing and blastocyst cultureEmbryos derived from irregularly shaped oocytes. |
| Large PVS | – | Procedure: Cryopreservation, thawing and blastocyst cultureEmbryos derived from oocytes with large perivitelline space. |
| Dark Zona | – | Procedure: Cryopreservation, thawing and blastocyst cultureEmbryos derived from oocytes with dark zona pellucida |
| Dark cytoplasm | – | Procedure: Cryopreservation, thawing and blastocyst cultureEmbryos derived from oocytes with dark cytoplasm |
| Vacuolar cytoplasm | – | Procedure: Cryopreservation, thawing and blastocyst cultureEmbryos derived from oocytes with vacuolated cytoplasm |
| Central granulation | – | Procedure: Cryopreservation, thawing and blastocyst cultureEmbryos derived from oocytes with centrally granulated cytoplasm |
| Double extra | – | Procedure: Cryopreservation, thawing and blastocyst cultureEmbryos derived from oocytes with double extracytoplasmic abnormalities |
| Double combined | – | Procedure: Cryopreservation, thawing and blastocyst cultureEmbryos derived from oocytes with any combination of one extracytoplasmic and one cytoplasmic anomaly |
| Double cytoplasmic | – | Procedure: Cryopreservation, thawing and blastocyst cultureEmbryos derived from oocytes with any two cytoplasmic anomalies |
| Triple extra | – | Procedure: Cryopreservation, thawing and blastocyst cultureEmbryos derived from oocytes with triple extracytoplasmic anomaly |
| Triple combined | – | Procedure: Cryopreservation, thawing and blastocyst cultureEmbryos derived from oocytes with triple combined anomalies |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Human embryos derived from morphologically normal or abnormal mature oocytes that fertilized normally by microinjection procedure.
- Embryos were obtained from couples who refused to freeze their supernumerary embryos after fresh embryo transfer in an assisted reproduction treatment cycle.
Key exclusion criteria (2 listed)
- Embryos obtained after microinjection to immature oocytes taht were in vitro matured in culture.
- Embryos obtained from abnormally fertilized zygotes.
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 |
|---|---|---|
| Cryopreservation, thawing and blastocyst cultureGood quality human embryos were frozen - thawed and cultured to the blastocyst stage. | Procedure or surgery | Central granulation, Dark Zona, Dark cytoplasm, Double combined, Double cytoplasmic, Double extra, Irregular Shapes, Large PVS, Normal, Triple combined, Triple extra, Vacuolar cytoplasm |
Primary outcome
Not reported in the source record.
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 27 Aug 2007.
- Derived from this study: PubMed 18477573Balaban B, Ata B, Isiklar A, Yakin K, Urman B. Severe cytoplasmic abnormalities of the oocyte decrease cryosurvival and subsequent embryonic development of cryopreserved embryos. Hum Reprod. 2008 Aug;23(8):1778-85. doi: 10.1093/humrep/den127. Epub 2008 May 12.
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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, B.Sc. study director
Assisted Reproduction Unit of the VKV 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?
An observational study of Cryopreservation and Blastocyst, 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 2 inclusion and 2 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 27 Aug 2007. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00521443, 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 27 Aug 2007.