PregnancyIVF-2010NCT01287273
The Impact of Early Embryos Incubation on Pregnancy Rate in IVF
An observational study of Pregnancy and In Vitro Fertilization, run by Martha Dirnfeld at 1 site in Israel.
Trial summary
Frozen- thawed embryos obtained by IVF treatments are transferred to the uterus immediately following thawing or after incubation for additional 24-72 hours. The two methods are routine in IVF laboratories. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, In Vitro Fertilization
- How many people
- 660 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Feb 2014
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 660 IVF patients. patients who are candidates for embryo cryopreservation cycle will be offered to participate in the present prospective randomized study. After detailed verbal and written explanation on the study protocol they will sign an informed consent and then randomized to 2 groups.
Who may be able to join
- IVF patient who have thawed embryo transfer and can read understand and sigh on informed consent
Who cannot join
- IVF patient who have thawed embryo transfer and can not read understand and sigh on informed consent/ also those whos embryos will not survive freezing- thawing
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa, 34362
Martha Dirnfeld, MD, 8250335 ext. 9724, dirnfeld_martha@clalit.org.il
Shirly Lahav-Baratz, D.Sc, 8250118 ext. 9724, lahav_shirly@clalit.org.il
About this study
Frozen- thawed embryos obtained by IVF treatments are transferred to the uterus immediately following thawing or after incubation for additional 24-72 hours. The two methods are routine in IVF laboratories. In this study the investigators would like to compare between these two methods in terms of implantation rate, pregnancy rate and delivery.
Read the detailed description
It has been common practice to cryopreserve surplus embryos achieved during IVF treatment or in other situation that embryos are to be preserved for other situations such as suspected ovarian hyper stimulation syndrome, fertility preservation or patient request.
Embryos are usually frozen on day 2, 3 or day 5-6 at the Blastocyst stage. At the time that thawing is planned, patients' cycle is synchronized and prepared either with hormonal treatment or at the natural cycle.
Not all embryos will always survive the thawing and sometimes they will all degenerate.
Embryos that survive the thawing procedure are assessed and replaced on the day of the thaw or left overnight for better selection and will be replaced only if they continue to divide in vitro.
The advantage of embryo transfer on the day of thaw is that embryo exposure in culture is shortened and embryo selection will be occurring in the womb. On the other hand, overnight incubation may avoid transferring embryos that potentially are not able to divide and are biologically not viable.
Although both attitudes are practiced in different IVF centers, at present there are no prospective randomized studies that have been conducted to advise which intervention is better in terms of pregnancy rates.
The purpose of the present study is to assess which technique will result in better pregnancy rates.
- Conditions
- Pregnancy, In Vitro Fertilization
- Keywords
- frozen-thawed, IVF, incubation, pregnancy rate, Pregnancy rate of frozen-thawed embryos of IVF treatments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Transfer at the day of embryo thawing | |
| Group B | Transfer of thawed embryos 24-72 hours post thawing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy as measured by blood test for beta hCG
as the usual routine, the women come on day 12 or 13 following embryo transfer to pur IVF unit to get blood teat for beta hCG. When the result show that the beta hCG is above 5 unit/liter we consider it as positive result and the patients is invited for additional blood test 2 days later/
Measured: 12 days following embryos transfer
Secondary outcomes (1)
Delivery of baby
We are routinely report to the Israeli ministry of health all the children who were born from our treatment. In this study we will calculate the number of children per thawed embryo transfer.
Measured: 9 mounth after embryos transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martha Dirnfeld
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martha Dirnfeld, Carmel Medical Center
- Investigators
- Martha Dirnfeld, MD, Principal investigator, Carmel Medical Center IVF Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287273
- Sponsor's protocol ID
- CMC-10-0010-CTIL
- Acronym
- IVF-2010
- Status last verified
- Dec 2013
- First submitted
- 25 Jan 2011
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lahav-Baratz S, Koifman M, Shiloh H, Ishai D, Wiener-Megnazi Z, Dirnfeld M. Analyzing factors affecting the success rate of frozen-thawed embryos. J Assist Reprod Genet. 2003 Nov;20(11):444-8. doi: 10.1023/b:jarg.0000006705.46147.a2.
PubMed 14714822Lahav-Baratz S, Shiloh H, Koifman M, Kraiem Z, Wiener-Megnazi Z, Ishai D, Dirnfeld M. Early embryo-endometrial signaling modulates the regulation of matrix metalloproteinase-3. Fertil Steril. 2004 Oct;82 Suppl 3:1029-35. doi: 10.1016/j.fertnstert.2004.06.026.
PubMed 15474069
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early Embryos Incubation on Pregnancy Rate in IVF
- ClinicalTrials.gov ID
- NCT01287273
- Acronym / sponsor ID
- IVF-2010 / CMC-10-0010-CTIL
- Conditions
- Pregnancy, In Vitro Fertilization
- Keywords
- frozen-thawed, IVF, incubation, pregnancy rate, Pregnancy rate of frozen-thawed embryos of IVF treatments
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Martha DirnfeldUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (estimated)
- First posted
- 1 Feb 2011 (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.
Frozen- thawed embryos obtained by IVF treatments are transferred to the uterus immediately following thawing or after incubation for additional 24-72 hours. The two methods are routine in IVF laboratories. In this study the investigators would like to compare between these two methods in terms of implantation rate, pregnancy rate and delivery.
Detailed description
It has been common practice to cryopreserve surplus embryos achieved during IVF treatment or in other situation that embryos are to be preserved for other situations such as suspected ovarian hyper stimulation syndrome, fertility preservation or patient request.
Embryos are usually frozen on day 2, 3 or day 5-6 at the Blastocyst stage. At the time that thawing is planned, patients' cycle is synchronized and prepared either with hormonal treatment or at the natural cycle.
Not all embryos will always survive the thawing and sometimes they will all degenerate.
Embryos that survive the thawing procedure are assessed and replaced on the day of the thaw or left overnight for better selection and will be replaced only if they continue to divide in vitro.
The advantage of embryo transfer on the day of thaw is that embryo exposure in culture is shortened and embryo selection will be occurring in the womb. On the other hand, overnight incubation may avoid transferring embryos that potentially are not able to divide and are biologically not viable.
Although both attitudes are practiced in different IVF centers, at present there are no prospective randomized studies that have been conducted to advise which intervention is better in terms of pregnancy rates.
The purpose of the present study is to assess which technique will result in better pregnancy rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Transfer at the day of embryo thawing |
| Group B | – | –Transfer of thawed embryos 24-72 hours post thawing |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 660 IVF patients. patients who are candidates for embryo cryopreservation cycle will be offered to participate in the present prospective randomized study. After detailed verbal and written explanation on the study protocol they will sign an informed consent and then randomized to 2 groups.
Key inclusion criteria (1 listed)
- IVF patient who have thawed embryo transfer and can read understand and sigh on informed consent
Key exclusion criteria (1 listed)
- IVF patient who have thawed embryo transfer and can not read understand and sigh on informed consent/ also those whos embryos will not survive freezing- thawing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pregnancy as measured by blood test for beta hCG
Time frame: 12 days following embryos transfer
as the usual routine, the women come on day 12 or 13 following embryo transfer to pur IVF unit to get blood teat for beta hCG. When the result show that the beta hCG is above 5 unit/liter we consider it as positive result and the patients is invited for additional blood test 2 days later/
1 secondary outcome
Delivery of baby
Time frame: 9 mounth after embryos transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
- Background: PubMed 14714822Lahav-Baratz S, Koifman M, Shiloh H, Ishai D, Wiener-Megnazi Z, Dirnfeld M. Analyzing factors affecting the success rate of frozen-thawed embryos. J Assist Reprod Genet. 2003 Nov;20(11):444-8. doi: 10.1023/b:jarg.0000006705.46147.a2.
- Background: PubMed 15474069Lahav-Baratz S, Shiloh H, Koifman M, Kraiem Z, Wiener-Megnazi Z, Ishai D, Dirnfeld M. Early embryo-endometrial signaling modulates the regulation of matrix metalloproteinase-3. Fertil Steril. 2004 Oct;82 Suppl 3:1029-35. doi: 10.1016/j.fertnstert.2004.06.026.
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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.
Martha Dirnfeld, MD principal investigator
Carmel Medical Center IVF Unit
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 and In Vitro Fertilization, run by Martha Dirnfeld at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Dec 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martha Dirnfeld, MD (8250335 ext. 9724, dirnfeld_martha@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy as measured by blood test for beta hCG (time frame: 12 days following embryos transfer). 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 NCT01287273, which also lists 2 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 6 Dec 2013.