InfertilityLATEBLOOMNCT03360097
Clinical Outcomes of Slow Developing Blastocysts
A study testing Frozen Embryo Transfer in people with Infertility, run by Fundacion Dexeus at 1 site in Spain.
Trial summary
This study evaluates which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an IVF cycle is classified as expansion grade <4 by Gardner and Schoolcraft classification. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Frozen Embryo Transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2017to 30 May 2018
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All IVF cycles undergoing autologous fresh blastocyst embryo transfer
- All IVF cycles in which the best available embryo for transfer is at expansion grade <4
- All ages
Who cannot join
- Ovum Donation cycles
- Preimplantation genetic testing cycles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregnancy Outcomes in Patients With Slow Developing Blastocysts: What is the Best Transfer Strategy? A Prospective Randomized Controlled Trial
This study evaluates which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an IVF cycle is classified as expansion grade <4 by Gardner and Schoolcraft classification. All cycles will be cultured to day 6 and half the patients will undergo a fresh embryo transfer and the other half a frozen embryo transfer.
Read the detailed description
A lack of established markers for predicting blastocyst development increases the risk of having no embryos or embryos not-fully expanded available for transfer. Slower but non-arrested embryos are frequently found to have progressed to blastocyst stage by the time of a day 6 transfer. In the absence of a receptive endometrium, embryo selection for fresh transfer may be futile, and cryopreservation could be a better option. The objective is to determine which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an IVF cycle is classified as expansion grade <4 by Gardner and Schoolcraft classification. The investigators hypothesize that in bad prognosis patients with slow-developing blastocysts, vitrified-warmed embryo transfer will result in higher implantation, clinical and ongoing pregnancy and live birth rates than fresh embryo transfer.
- Conditions
- Infertility
- Being tested
- Frozen Embryo Transfer
- Keywords
- In vitro Fertilization, Slow Developing Blastocyst, Fresh Embryo Transfer, Frozen Embryo Transfer, Live Birth Rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frozen Embryo TransferProcedure or surgery
Patient's embryos are cultured to day 6, vitrified and transferred in a cryo-synthetic cycle
| Study group | Role | What they receive |
|---|---|---|
| Fresh ET | No intervention | The best available embryo is at expansion grade <4 by Gardner classification 5 days after oocyte retrieval. Patient's embryos are cultured to day 6 and transferred regardless of expansion grade. Arrested blastocysts are discarded. |
| Frozen Embryo Transfer | Experimental | The best available embryo is at expansion grade <4 by Gardner classification 5 days after oocyte retrieval. Patient's embryos are cultured to day 6 and vitrified regardless of expansion grade. Arrested blastocysts are discarded. The single best available embryo is transferred under a cryo-synthetic cycle. Receives: Procedure: Frozen Embryo Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Proportion of patients with the presence of a gestational sac seen by transvaginal ultrasonography 20 days after the embryo transfer
Measured: 20 days after date of embryo transfer
Secondary outcomes (4)
Biochemical Pregnancy Rate
Proportion of patients with the detection of β-hCG level ≥5 mIU/mL 9 days after the embryo transfer
Measured: 9 days after date of embryo transfer
Live Birth Rate
Proportion of patients which deliver a live infant after 24 weeks of gestation
Measured: 24 weeks after the embryo transfer
Miscarriage Rate
Proportion of patients with a pregnancy loss following a positive pregnancy test and/or detectable gestacional sac
Measured: 14 weeks after the embryo transfer
Cryopreservation-thaw rate
Proportion of vitrified blastocysts which survive the re-warming
Measured: 1 day after the thawing procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Dec 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Why it stopped: No participants met the inclusion criteria in an exted period of time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Model description
- All participants will be randomized by an intention to treat approach. Randomization at the blastocyst stage is chosen to avoid cycle cancellation if randomized earlier. All components of the IVF/ICSI cycle including stimulation medications, monitoring protocols, etc. will be at the discretion of the participant's primary physician; while this information will be documented it will not constitute criteria for enrolment. The group allocation will take place the day of the embryo transfer. The clinician will randomize all included patients into one of the two study groups using an open computer-generated list. An interim analysis is planned and sample size will be plan accordingly, under the Pocok method, including 2 stages, with p-value as boundary scale, calculated to have 80% power to detect a 20% difference with a reference proportion of 25% clinical pregnancy rate and a one-sided (upper) alpha of 0.025
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Rodriguez-Purata, Fundacion Dexeus
- Investigators
- Jorge Rodriguez-Purata, MD, Principal investigator, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360097
- Sponsor's protocol ID
- SMD-SLOW-2017-10
- Acronym
- LATEBLOOM
- Status last verified
- May 2018
- First submitted
- 14 Nov 2017
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcomes in Patients With Slow Developing Blastocysts: What is the Best Transfer Strategy? A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03360097
- Acronym / sponsor ID
- LATEBLOOM / SMD-SLOW-2017-10
- Conditions
- Infertility
- Keywords
- In vitro Fertilization, Slow Developing Blastocyst, Fresh Embryo Transfer, Frozen Embryo Transfer, Live Birth Rate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No participants met the inclusion criteria in an exted period of time.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 2 Dec 2017 (actual)
- 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.
This study evaluates which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an IVF cycle is classified as expansion grade <4 by Gardner and Schoolcraft classification. All cycles will be cultured to day 6 and half the patients will undergo a fresh embryo transfer and the other half a frozen embryo transfer.
Detailed description
A lack of established markers for predicting blastocyst development increases the risk of having no embryos or embryos not-fully expanded available for transfer. Slower but non-arrested embryos are frequently found to have progressed to blastocyst stage by the time of a day 6 transfer. In the absence of a receptive endometrium, embryo selection for fresh transfer may be futile, and cryopreservation could be a better option. The objective is to determine which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an IVF cycle is classified as expansion grade <4 by Gardner and Schoolcraft classification. The investigators hypothesize that in bad prognosis patients with slow-developing blastocysts, vitrified-warmed embryo transfer will result in higher implantation, clinical and ongoing pregnancy and live birth rates than fresh embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will be randomized by an intention to treat approach. Randomization at the blastocyst stage is chosen to avoid cycle cancellation if randomized earlier. All components of the IVF/ICSI cycle including stimulation medications, monitoring protocols, etc. will be at the discretion of the participant's primary physician; while this information will be documented it will not constitute criteria for enrolment. The group allocation will take place the day of the embryo transfer. The clinician will randomize all included patients into one of the two study groups using an open computer-generated list. An interim analysis is planned and sample size will be plan accordingly, under the Pocok method, including 2 stages, with p-value as boundary scale, calculated to have 80% power to detect a 20% difference with a reference proportion of 25% clinical pregnancy rate and a one-sided (upper) alpha of 0.025
| Arm | Type | Receives |
|---|---|---|
| Fresh ET | No intervention | –The best available embryo is at expansion grade <4 by Gardner classification 5 days after oocyte retrieval. Patient's embryos are cultured to day 6 and transferred regardless of expansion grade. Arrested blastocysts are discarded. |
| Frozen Embryo Transfer | Experimental | Procedure: Frozen Embryo TransferThe best available embryo is at expansion grade <4 by Gardner classification 5 days after oocyte retrieval. Patient's embryos are cultured to day 6 and vitrified regardless of expansion grade. Arrested blastocysts are discarded. The single best available embryo is transferred under a cryo-synthetic cycle. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All IVF cycles undergoing autologous fresh blastocyst embryo transfer
- All IVF cycles in which the best available embryo for transfer is at expansion grade <4
- All ages
Key exclusion criteria (2 listed)
- Ovum Donation cycles
- Preimplantation genetic testing cycles
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 |
|---|---|---|
| Frozen Embryo TransferPatient's embryos are cultured to day 6, vitrified and transferred in a cryo-synthetic cycle | Procedure or surgery | Frozen Embryo Transfer |
Primary outcome
Clinical Pregnancy Rate
Time frame: 20 days after date of embryo transfer
Proportion of patients with the presence of a gestational sac seen by transvaginal ultrasonography 20 days after the embryo transfer
4 secondary outcomes
Biochemical Pregnancy Rate
Time frame: 9 days after date of embryo transfer
Live Birth Rate
Time frame: 24 weeks after the embryo transfer
Miscarriage Rate
Time frame: 14 weeks after the embryo transfer
Cryopreservation-thaw rate
Time frame: 1 day after the thawing procedure
Results and safety
The study was stopped early (reason given: No participants met the inclusion criteria in an exted period of time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
Jorge Rodriguez-Purata, MD principal investigator
Fundacion Dexeus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frozen Embryo Transfer in people with Infertility, run by Fundacion Dexeus at 1 site in Spain.
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 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: stopped early, as of the sponsor's last update on 1 Jun 2018. 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 Spain. 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 was stopped early (reason given: No participants met the inclusion criteria in an exted period of time.). Results are not available in the source record.
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?
Clinical Pregnancy Rate (time frame: 20 days after date of embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2018.