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Cleave-stage Transfer on Day 3 Versus Day 5 Transfer When Only One Embryo Available

NCT04210414 — Not applicable, Terminated, 83 participants, Ibn Sina Hospital

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Transfer of Single Embryo on Day 3 or 5 When Only One Embryo Transfer

RegistryNCT04210414, acronym Cleave-blast
StatusTerminated - COVID19 Pandemic affected recruitment across 2020 and the stringent inclusion criteria makes the proposed sample size to be likely unachievable in reasonable period.
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, other
Enrollment83 (Actual)
SponsorIbn Sina Hospital (Other gov)
ConditionsInfertility
InterventionsEmbryo transfer (Other)
Datesstart 2020-01-10, primary completion 2021-11-10, completion 2021-11-10, first posted 2019-12-24, last updated 2022-06-15
Locations3 sites in Egypt

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-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.

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+Detailed description

Recruitment is very slow. The TSC will discuss termination next meeting with the DMC.

+Arms and interventions

ArmTypeInterventionsDescription
Day 3 transferExperimentalOther: Embryo transferTransfer on day 3 when only one embryo is available
Day 5 transferExperimentalOther: Embryo transferTransfer on day 5 when only one embryo is available
  • Embryo transfer (Other): Transfer of only one embryo

+Outcome measures

Primary outcomes

  • Ongoing pregnancy rate [within 20 weeks of gestation]

Secondary outcomes

  • Biochemical pregnancy rate [One month]
  • clinical pregnancy [7 weeks of gestation]
  • Embryo development after In vitro fertilization cycle [6 days after in vitro fertilization]

+Eligibility

Sex: Female, ages: 18 Years to 42 Years

Inclusion Criteria:

* Infertile couple with only one embryo available for transfer

Exclusion Criteria:

* ineligible for study

+Locations (3)

FacilityCityCountryStatus
Qena Fertility CenterQina, Qena GovernorateEgypt
Banon AssiutAsyutEgypt
IbnSina IVF Center, IbnSina HospitalSohagEgypt

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