InfertilityCleave-blastNCT04210414
Cleave-stage Transfer on Day 3 Versus Day 5 Transfer When Only One Embryo Available
A study testing Embryo transfer in people with Infertility, run by Ibn Sina Hospital at 3 sites in Egypt.
Trial summary
When only one embryo is available after in vitro fertilization, the option is to transfer either day 3 or day 5. There is no randomized trial compared the day 3 to day 5 for this subgroup. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Embryo transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 3 sitesEgypt
- Study dates
- 10 Jan 2020to 10 Nov 2021
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile couple with only one embryo available for transfer
Who cannot join
- ineligible for study
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Banon Assiut
Asyut
Qena Fertility Center
Qina, Qena Governorate, 123456
IbnSina IVF Center, IbnSina Hospital
Sohag, 12345
About this study
Official title: Transfer of Single Embryo on Day 3 or 5 When Only One Embryo Transfer
When only one embryo is available after in vitro fertilization, the option is to transfer either day 3 or day 5. There is no randomized trial compared the day 3 to day 5 for this subgroup.
Read the detailed description
Recruitment is very slow. The TSC will discuss termination next meeting with the DMC.
- 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 transferOther
Transfer of only one embryo
| Study group | Role | What they receive |
|---|---|---|
| Day 3 transfer | Experimental | Transfer on day 3 when only one embryo is available Receives: Other: Embryo transfer |
| Day 5 transfer | Experimental | Transfer on day 5 when only one embryo is available Receives: Other: Embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Measured: within 20 weeks of gestation
Secondary outcomes (3)
Biochemical pregnancy rate
Measured: One month
clinical pregnancy
Measured: 7 weeks of gestation
Embryo development after In vitro fertilization cycle
Measured: 6 days after in vitro fertilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start10 Jan 2020
- Primary completion10 Nov 2021
- Study completion10 Nov 2021
Why it stopped: COVID19 Pandemic affected recruitment across 2020 and the stringent inclusion criteria makes the proposed sample size to be likely unachievable in reasonable period.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210414
- Sponsor's protocol ID
- IbnSina-ET
- Acronym
- Cleave-blast
- Status last verified
- Jun 2022
- First submitted
- 21 Dec 2019
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer of Single Embryo on Day 3 or 5 When Only One Embryo Transfer
- ClinicalTrials.gov ID
- NCT04210414
- Acronym / sponsor ID
- Cleave-blast / IbnSina-ET
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID19 Pandemic affected recruitment across 2020 and the stringent inclusion criteria makes the proposed sample size to be likely unachievable in reasonable period.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 24 Dec 2019 (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.
When only one embryo is available after in vitro fertilization, the option is to transfer either day 3 or day 5. There is no randomized trial compared the day 3 to day 5 for this subgroup.
Detailed description
Recruitment is very slow. The TSC will discuss termination next meeting with the DMC.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day 3 transfer | Experimental | Other: Embryo transferTransfer on day 3 when only one embryo is available |
| Day 5 transfer | Experimental | Other: Embryo transferTransfer on day 5 when only one embryo is available |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Infertile couple with only one embryo available for transfer
Key exclusion criteria (1 listed)
- ineligible for study
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 transferTransfer of only one embryo | Other | Day 3 transfer, Day 5 transfer |
Primary outcome
Ongoing pregnancy rate
Time frame: within 20 weeks of gestation
3 secondary outcomes
Biochemical pregnancy rate
Time frame: One month
clinical pregnancy
Time frame: 7 weeks of gestation
Embryo development after In vitro fertilization cycle
Time frame: 6 days after in vitro fertilization
Results and safety
The study was stopped early (reason given: COVID19 Pandemic affected recruitment across 2020 and the stringent inclusion criteria makes the proposed sample size to be likely unachievable in reasonable period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 Ibn Sina Hospital at 3 sites in Egypt.
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: stopped early, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. 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: COVID19 Pandemic affected recruitment across 2020 and the stringent inclusion criteria makes the proposed sample size to be likely unachievable in reasonable period.). 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?
Ongoing pregnancy rate (time frame: within 20 weeks of gestation). 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 15 Jun 2022.