PregnancyNCT01088425
Vitrification Versus Spontaneous Conception and Slow- Rate Freezing
An observational study of Pregnancy, run by University of Luebeck at 1 site in Germany.
Trial summary
Great scientific effort has been made to improve practical as well as economical procedures of modern assisted reproduction. In the last years a shift from the well established method of slow-rate freezing to vitrification of 2PN zygotes and embryos could be observed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pregnancy
- What is being tested?
- Observation
- How many people
- 850 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: tertiary university hospital
Who may be able to join
- cryopreservation (vitrification and slow- rate freezing) between 1998 - 2010
- Treatment in Lübeck University
- Delivery in Lübeck University
- Positive informed consent
Who cannot join
- Negative informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Schleswig- Holstein University, Campus Lübeck, Department of Reproductive Medicine
Lübeck, Schleswig-Holstein, D-23538
About this study
Official title: Maternal Pregnancy and Neonatal Outcome After Assisted Reproduction. Comparison of Vitrification vs. Spontaneous Conception
Great scientific effort has been made to improve practical as well as economical procedures of modern assisted reproduction.
In the last years a shift from the well established method of slow-rate freezing to vitrification of 2PN zygotes and embryos could be observed. Like any other method of cryopreservation, the outcome of vitrification will be affected by several factors related to technique itself, its practical management and patient characteristics.
Read more
The investigators want to investigate the influence of vitrification on the outcome of of 2PN oocytes, pregnancy and infant health.
A Comparison between a cohort of spontaneous conceived children and children of vitrified and slow- cooled 2PN oocytes is planned.
- Conditions
- Pregnancy
- Being tested
- Observation
- Keywords
- vitrification, 2PN oocyte, maternal and infant health, embryo survival, clinical pregnancy rate, mode of delivery, injury during delivery, infant development, infant morbidity, slow- rate freezing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Alberta infant motor scale
Griffiths test
Kauffmann ABC
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous | Mothers with children conceived after spontaneous cycle Receives: Other: Observation | |
| Vitrificatíon | Mothers with children conceived after vitrification cycle Receives: Other: Observation | |
| slow- rate freezing | Mothers with children conceived after slow- rate freezing cycle Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal pregancy outcome
spontaneous or operative delivery, birth injuries, conjoined morbidity
Measured: 7 years
embryo survival
embryo survival rate
Measured: 7 years
Secondary outcomes (1)
infant health
infant vital characteristics (APGAR, arterial cord ph), infant development: only develomental milestones: sitting, standing, walking infant morbidity
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Alexander Beyer, University of Luebeck
- Investigators
- Daniel A Beyer, MD, Principal investigator, Lübeck University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088425
- Sponsor's protocol ID
- UKSH-HL-09-195
- Other IDs
- 09-195
- Status last verified
- Mar 2017
- First submitted
- 16 Mar 2010
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wennerholm UB, Soderstrom-Anttila V, Bergh C, Aittomaki K, Hazekamp J, Nygren KG, Selbing A, Loft A. Children born after cryopreservation of embryos or oocytes: a systematic review of outcome data. Hum Reprod. 2009 Sep;24(9):2158-72. doi: 10.1093/humrep/dep125. Epub 2009 May 20.
PubMed 19458318Kagawa N, Kuwayama M, Nakata K, Vajta G, Silber S, Manabe N, Kato O. Production of the first offspring from oocytes derived from fresh and cryopreserved pre-antral follicles of adult mice. Reprod Biomed Online. 2007 Jun;14(6):693-9. doi: 10.1016/s1472-6483(10)60670-0.
PubMed 17579980Noyes N, Porcu E, Borini A. Over 900 oocyte cryopreservation babies born with no apparent increase in congenital anomalies. Reprod Biomed Online. 2009 Jun;18(6):769-76. doi: 10.1016/s1472-6483(10)60025-9.
PubMed 19490780Noyes N, Knopman J, Labella P, McCaffrey C, Clark-Williams M, Grifo J. Oocyte cryopreservation outcomes including pre-cryopreservation and post-thaw meiotic spindle evaluation following slow cooling and vitrification of human oocytes. Fertil Steril. 2010 Nov;94(6):2078-82. doi: 10.1016/j.fertnstert.2010.01.019. Epub 2010 Feb 26.
PubMed 20188356Ubaldi F, Anniballo R, Romano S, Baroni E, Albricci L, Colamaria S, Capalbo A, Sapienza F, Vajta G, Rienzi L. Cumulative ongoing pregnancy rate achieved with oocyte vitrification and cleavage stage transfer without embryo selection in a standard infertility program. Hum Reprod. 2010 May;25(5):1199-205. doi: 10.1093/humrep/deq046. Epub 2010 Feb 25.
PubMed 20185513Al-Hasani S, Ozmen B, Koutlaki N, Schoepper B, Diedrich K, Schultze-Mosgau A. Three years of routine vitrification of human zygotes: is it still fair to advocate slow-rate freezing? Reprod Biomed Online. 2007 Mar;14(3):288-93. doi: 10.1016/s1472-6483(10)60869-3.
PubMed 17359578
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Pregnancy and Neonatal Outcome After Assisted Reproduction. Comparison of Vitrification vs. Spontaneous Conception
- ClinicalTrials.gov ID
- NCT01088425
- Acronym / sponsor ID
- UKSH-HL-09-195
- Conditions
- Pregnancy
- Keywords
- vitrification, 2PN oocyte, maternal and infant health, embryo survival, clinical pregnancy rate, mode of delivery, injury during delivery, infant development, infant morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Mar 2010 (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.
Great scientific effort has been made to improve practical as well as economical procedures of modern assisted reproduction.
In the last years a shift from the well established method of slow-rate freezing to vitrification of 2PN zygotes and embryos could be observed. Like any other method of cryopreservation, the outcome of vitrification will be affected by several factors related to technique itself, its practical management and patient characteristics.
The investigators want to investigate the influence of vitrification on the outcome of of 2PN oocytes, pregnancy and infant health.
A Comparison between a cohort of spontaneous conceived children and children of vitrified and slow- cooled 2PN oocytes is planned.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spontaneous | – | Other: ObservationMothers with children conceived after spontaneous cycle |
| Vitrificatíon | – | Other: ObservationMothers with children conceived after vitrification cycle |
| slow- rate freezing | – | Other: ObservationMothers with children conceived after slow- rate freezing cycle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- tertiary university hospital
Key inclusion criteria (4 listed)
- cryopreservation (vitrification and slow- rate freezing) between 1998 - 2010
- Treatment in Lübeck University
- Delivery in Lübeck University
- Positive informed consent
Key exclusion criteria (1 listed)
- Negative informed consent
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 |
|---|---|---|
| ObservationAlberta infant motor scale Griffiths test Kauffmann ABC | Other | Spontaneous, Vitrificatíon, slow- rate freezing |
Primary outcome
Maternal pregancy outcome
Time frame: 7 years
spontaneous or operative delivery, birth injuries, conjoined morbidity
embryo survival
Time frame: 7 years
embryo survival rate
1 secondary outcome
infant health
Time frame: 7 years
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 14 Mar 2017.
- Background: PubMed 19458318Wennerholm UB, Soderstrom-Anttila V, Bergh C, Aittomaki K, Hazekamp J, Nygren KG, Selbing A, Loft A. Children born after cryopreservation of embryos or oocytes: a systematic review of outcome data. Hum Reprod. 2009 Sep;24(9):2158-72. doi: 10.1093/humrep/dep125. Epub 2009 May 20.
- Background: PubMed 17579980Kagawa N, Kuwayama M, Nakata K, Vajta G, Silber S, Manabe N, Kato O. Production of the first offspring from oocytes derived from fresh and cryopreserved pre-antral follicles of adult mice. Reprod Biomed Online. 2007 Jun;14(6):693-9. doi: 10.1016/s1472-6483(10)60670-0.
- Background: PubMed 19490780Noyes N, Porcu E, Borini A. Over 900 oocyte cryopreservation babies born with no apparent increase in congenital anomalies. Reprod Biomed Online. 2009 Jun;18(6):769-76. doi: 10.1016/s1472-6483(10)60025-9.
- Background: PubMed 20188356Noyes N, Knopman J, Labella P, McCaffrey C, Clark-Williams M, Grifo J. Oocyte cryopreservation outcomes including pre-cryopreservation and post-thaw meiotic spindle evaluation following slow cooling and vitrification of human oocytes. Fertil Steril. 2010 Nov;94(6):2078-82. doi: 10.1016/j.fertnstert.2010.01.019. Epub 2010 Feb 26.
- Background: PubMed 20185513Ubaldi F, Anniballo R, Romano S, Baroni E, Albricci L, Colamaria S, Capalbo A, Sapienza F, Vajta G, Rienzi L. Cumulative ongoing pregnancy rate achieved with oocyte vitrification and cleavage stage transfer without embryo selection in a standard infertility program. Hum Reprod. 2010 May;25(5):1199-205. doi: 10.1093/humrep/deq046. Epub 2010 Feb 25.
- Background: PubMed 17359578Al-Hasani S, Ozmen B, Koutlaki N, Schoepper B, Diedrich K, Schultze-Mosgau A. Three years of routine vitrification of human zygotes: is it still fair to advocate slow-rate freezing? Reprod Biomed Online. 2007 Mar;14(3):288-93. doi: 10.1016/s1472-6483(10)60869-3.
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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.
Daniel A Beyer, MD principal investigator
Lübeck University
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 Pregnancy, run by University of Luebeck at 1 site in Germany.
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 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 14 Mar 2017. 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 Germany. 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?
Maternal pregancy outcome (time frame: 7 years). The study lists 2 primary outcomes in all. 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 NCT01088425, which also lists 6 linked publications.
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 14 Mar 2017.