Sperm Separation Efficiency to Maximize Pregnancy Rates: MACS vs. FERTILE Chip
FERTIMACS
1 other identifier
observational
84
1 country
1
Brief Summary
The goal of this observational study is to compare clinical outcomes of two techniques for sperm cell sorting, microfluidic sorting and magnetic activated cell sorting (MACS) technique, in males with high DNA fragmentation within an assisted reproductive treatment. The main questions it aims to answer are:
- Does microfluidic sorting improve pregnancy rate compared to MACS?
- Does microfluidic sorting improve fertilization rate compared to MACS?
- Does microfluidic sorting improve implantation rate compared to MACS?
- Does microfluidic sorting improve blastocyst development rate compared to MACS? Participants will deposit an eyaculate sample that will be analyzed for DNA fragmentation using a aliquot, then split in two to perform MACS and the microfluidic sorting. Both will be tested for DNA fragmentation (aliquotes) and used for the ICSI treatment with donor oocytes. Researchers will compare both techniques to see if the selection of the best functional spermatozoa with less DNA fragmentation and clinical outcomes improve.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2019
CompletedFirst Submitted
Initial submission to the registry
August 16, 2019
CompletedFirst Posted
Study publicly available on registry
August 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2022
CompletedOctober 4, 2024
October 1, 2024
1.8 years
August 16, 2019
October 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy rate
Total of positive pregnancies / total of patients with embryo transfer
Mar 2019 - Oct 2021
Secondary Outcomes (3)
Fertilization rate
Mar 2019 - Oct 2021
Implantation rate
Mar 2019 - Oct 2021
Blastocyst rate
Mar 2019 - Oct 2021
Study Arms (1)
Experimental arm
One half of the oocyte cohort is microinjected with sperm selected by the Fertile technique, while the other half of the patient's oocyte cohort is microinjected with sperm selected by the MACS technique.
Eligibility Criteria
Infertile patients needing an IVF treatment
You may qualify if:
- Oocyte recipient patients
You may not qualify if:
- Sperm concentration \< 5 Mill/ml
- Percentage of motile sperm \< 15%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vida Recoletas Sevillalead
- IVI Madridcollaborator
Study Sites (1)
IVI RMA Seville
Seville, 41011, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cristina González Ravina, PhD
IVI RMA Seville
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2019
First Posted
August 19, 2019
Study Start
August 8, 2019
Primary Completion
May 15, 2021
Study Completion
January 9, 2022
Last Updated
October 4, 2024
Record last verified: 2024-10