InfertilityBlastoTransNCT02639000
Effects of Blastocyst Stage Compared With Cleavage Stage Embryo Transfer in Women Below 39 Years
A study testing Embryo transfer in people with Infertility, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Single center randomized study including 388 women aged less than 39 years, performing in vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs) improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Embryo transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2010to Apr 2016
- 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 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female patients undergoing IVF procedures
- age less than 39 years
Who cannot join
- less than 4 fertilized eggs in day 1 after IVF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Blastocyst Stage Embryo Transfer Compared With Cleavage Stage Embryo Transfer in Women ≤ 38 Years
Single center randomized study including 388 women aged less than 39 years, performing in vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs) improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs.
Read the detailed description
Embryos from in vitro fertilization are routinely transferred into the woman's uterus at cleavage stage (Day 2 to 3) or at blastocyst stage (Day 5 to 6).
The rational of blastocyst stage transfer is that blastocyst stage is the most biologically correct stage for embryos to be in the uterus, and longer culture in the laboratory may give the possibility to reduce the number of genetically abnormal embryos.
The investigators design a single center randomized trial, including 388 women aged less than 39 years, performing in vitro fertilization, to confront blastocyst stage embryo transfers (ETs) and cleavage stage ETs. Each patient is randomized with a non blind randomization, based on a computer model, on the first day after fertilization.
The primary outcomes are implantation and pregnancy rate. The secondary outcome is to verify if blastocyst embryo transfer leads to a higher multiple-pregnancy rate.
An interim analysis takes place at one third of the population. Follow up is of 4 weeks for implantation rate, and covers 8 weeks regarding pregnancy rate.
- Conditions
- Infertility
- Being tested
- Embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryo transferProcedure or surgery
Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage
| Study group | Role | What they receive |
|---|---|---|
| Blastocyst | Experimental | Embryo transfer of at maximum 2 embryos at blastocyst stage Receives: Procedure: Embryo transfer |
| Cleavage | Active comparator | Embryo transfer of at maximum 2 embryos at cleavage stage Receives: Procedure: Embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Number of patients achieving a clinical pregnancy divided for embryo transfers
Measured: 8 weeks after inclusion
Secondary outcomes (2)
Multiple pregnancy rate
Number of multiple pregnancies divided for pregnant patients
Measured: 8 weeks after inclusion
Implantation rate
Number of gestational sacs divided for number of transferred embryos
Measured: 4 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startJul 2010
- Primary completionJan 2016
- Study completionApr 2016
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 InfertilityStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Emanuele Levi-Setti, MD, Study director, Humanitas Research Hospital Department of Gynecology, Division of Gynecology and Reproductive Medicine Humanitas Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639000
- Sponsor's protocol ID
- 736
- Acronym
- BlastoTrans
- Status last verified
- Oct 2016
- First submitted
- 15 Dec 2015
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Glujovsky D, Blake D, Farquhar C, Bardach A. Cleavage stage versus blastocyst stage embryo transfer in assisted reproductive technology. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD002118. doi: 10.1002/14651858.CD002118.pub4.
PubMed 22786480Levi-Setti PE, Cirillo F, Smeraldi A, Morenghi E, Mulazzani GEG, Albani E. No advantage of fresh blastocyst versus cleavage stage embryo transfer in women under the age of 39: a randomized controlled study. J Assist Reprod Genet. 2018 Mar;35(3):457-465. doi: 10.1007/s10815-017-1092-2. Epub 2017 Nov 22.
PubMed 29168022
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blastocyst Stage Embryo Transfer Compared With Cleavage Stage Embryo Transfer in Women ≤ 38 Years
- ClinicalTrials.gov ID
- NCT02639000
- Acronym / sponsor ID
- BlastoTrans / 736
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Dec 2015 (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.
Single center randomized study including 388 women aged less than 39 years, performing in vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs) improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs.
Detailed description
Embryos from in vitro fertilization are routinely transferred into the woman's uterus at cleavage stage (Day 2 to 3) or at blastocyst stage (Day 5 to 6).
The rational of blastocyst stage transfer is that blastocyst stage is the most biologically correct stage for embryos to be in the uterus, and longer culture in the laboratory may give the possibility to reduce the number of genetically abnormal embryos.
The investigators design a single center randomized trial, including 388 women aged less than 39 years, performing in vitro fertilization, to confront blastocyst stage embryo transfers (ETs) and cleavage stage ETs. Each patient is randomized with a non blind randomization, based on a computer model, on the first day after fertilization.
The primary outcomes are implantation and pregnancy rate. The secondary outcome is to verify if blastocyst embryo transfer leads to a higher multiple-pregnancy rate.
An interim analysis takes place at one third of the population. Follow up is of 4 weeks for implantation rate, and covers 8 weeks regarding pregnancy rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blastocyst | Experimental | Procedure: Embryo transferEmbryo transfer of at maximum 2 embryos at blastocyst stage |
| Cleavage | Active comparator | Procedure: Embryo transferEmbryo transfer of at maximum 2 embryos at cleavage stage |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- female patients undergoing IVF procedures
- age less than 39 years
Key exclusion criteria (1 listed)
- less than 4 fertilized eggs in day 1 after IVF
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 |
|---|---|---|
| Embryo transferEmbryo transfer of maximum of 2 embryos at cleavage or blastocyst stage | Procedure or surgery | Blastocyst, Cleavage |
Primary outcome
Pregnancy rate
Time frame: 8 weeks after inclusion
Number of patients achieving a clinical pregnancy divided for embryo transfers
2 secondary outcomes
Multiple pregnancy rate
Time frame: 8 weeks after inclusion
Implantation rate
Time frame: 4 weeks after inclusion
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 4 Oct 2016.
- Background: PubMed 22786480Glujovsky D, Blake D, Farquhar C, Bardach A. Cleavage stage versus blastocyst stage embryo transfer in assisted reproductive technology. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD002118. doi: 10.1002/14651858.CD002118.pub4.
- Derived from this study: PubMed 29168022Levi-Setti PE, Cirillo F, Smeraldi A, Morenghi E, Mulazzani GEG, Albani E. No advantage of fresh blastocyst versus cleavage stage embryo transfer in women under the age of 39: a randomized controlled study. J Assist Reprod Genet. 2018 Mar;35(3):457-465. doi: 10.1007/s10815-017-1092-2. Epub 2017 Nov 22.
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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.
Paolo Emanuele Levi-Setti, MD study director
Humanitas Research Hospital Department of Gynecology, Division of Gynecology and Reproductive Medicine Humanitas Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embryo transfer in people with Infertility, run by Istituto Clinico Humanitas at 1 site in Italy.
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 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 4 Oct 2016. 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 Italy. 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?
Pregnancy rate (time frame: 8 weeks after inclusion). 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 NCT02639000, 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 4 Oct 2016.