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Clinical Trials/NCT04956848
NCT04956848
Completed
Not Applicable

A Comparison of Two Models Used for Identifying Embryos With the Best Chance of Inducing Pregnancy: A Pilot Study

Vitrolife2 sites in 1 country165 target enrollmentOctober 6, 2021
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ConditionsIVFInfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
IVF
Sponsor
Vitrolife
Enrollment
165
Locations
2
Primary Endpoint
Clinical pregnancy rate
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

A pilot study to gather information on clinical pregnancy rates for preparation of the planning of a larger randomized controlled trial comparing two decision support tools: the deep learning tool iDAScore® and the current annotation model, KIDScore™ D5.

Registry
clinicaltrials.gov
Start Date
October 6, 2021
End Date
November 14, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Vitrolife
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Patients undergoing IVF/ICSI-treatment with controlled ovarian stimulation with gonadotrophins and the intention to treat by transfer of a single day 5 fresh blastocyst on day
  • •At least two good quality blastocysts (GQB) on day 5 (3BB or better on the Gardner scale), originating from normally fertilized oocytes (2PN).

Exclusion Criteria

  • •Previous participation in this RCT
  • •Concurrent participation in another investigation
  • •Intention to perform any form of preimplantation genetic testing
  • •Fertility preservation
  • •Planned transfer on day 2-4
  • •Female age \>42 years
  • •A reduced likelihood of obtaining two good quality blastocysts on day 5 as evidenced by an AFC \<5 (if available, AFC=antral follicle count)

Outcomes

Primary Outcomes

Clinical pregnancy rate

Time Frame: After 6 weeks of gestation

Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

Secondary Outcomes

  • Rate of non-viable intrauterine pregnancies per randomized patient(After 6 weeks of gestation)
  • Clinical pregnancy rate in patients with maternal age above 35(After 6 weeks of gestation)
  • Positive hCG rate per randomized patient(From day 13 following embryo transfer)

Study Sites (2)

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