Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
200

Summary

Conditions
Infertility Female
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective randomized clinical trialMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Allocation information will be handled by researcher coordinators only.Primary Purpose: Treatment

Participation Requirements

Age
Between 35 years and 40 years
Gender
Only males

Description

In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF centers will be recruited. Patients will be randomized to a control and to a treatment group, each containing 120 participants. Only patients with at least one evaluable blastocyst will be ra...

In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF centers will be recruited. Patients will be randomized to a control and to a treatment group, each containing 120 participants. Only patients with at least one evaluable blastocyst will be randomized. Patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by IVF center. In the control arm, patients will undergo a single frozen embryo transfer with an untested blastocyst with the best morphology. All other blastocysts with lower morphology will undergo trophectoderm biopsy on day 5, 6 or 7 and will be frozen. PGT-A results of the untransferred embryos will be revealed to the patient AFTER the outcome of the initial ET is known. If the initial transfer results in a non-conception cycle and additional euploid embryos are available for transfer, these cycles will be followed and their outcomes collected. In the experimental arm, all embryos will be cultured to blastocyst and all viable blastocysts will undergo trophectoderm biopsy and PGT-A. PGT-A will be performed regardless of the number of blastocysts available. Patients will undergo frozen transfer of the single, best quality euploid blastocyst. If the initial transfer results in a non-conception cycle and additional embryos are available for transfer, these cycles will be followed and their outcomes collected until the embryo cohort is exhausted.

Tracking Information

NCT #
NCT04167748
Collaborators
Not Provided
Investigators
Principal Investigator: Nathan R Treff, PhD Genomic Prediction