To Study the Effect of Magnetic Activated Sperm Sorting on the Outcome of in Vitro Fertilization-embryo Transplantation
MASS
1 other identifier
interventional
60
1 country
1
Brief Summary
Recent studies have evaluated the use of magnetic-activated sperm sorting (MASS) to reduce apoptotic spermatozoa and improve the outcome of infertile male with assisted reproductive technology (ART). However, some results were inconsistent with above. The sperm of male with abnormal semen analysis tend to be accompanied with high apoptotic and high DNA fragmentation index (DFI). Hence, this study aimed at determining the efficiency of MASS in improving the clinical outcome of patients with high DFI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
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
May 20, 2019
CompletedFirst Submitted
Initial submission to the registry
May 28, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2020
CompletedMay 30, 2019
May 1, 2019
12 months
May 28, 2019
May 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pregnancy rate
Pregnancy rate was defined from posi tive blood HCG and ultrasonography findings showing at least one embryo with a foetal heart beat 5 weeks after transfer.
2-3 months
Implantation rate
Implantation rate means the percentage of those embryos that implanted themselves into the uterine lining after having been transferred to the womb. Fetal heartbeat can be visualized via ultrasound in order to definitely confirm the implantation of the embryo.
2-3 months
Live-birth rate
Live birth rate was defined as the number of deliveries that resulted in a live born neonate.
1year
Study Arms (1)
Magnetic activated sperm cell sorting for infertile man
EXPERIMENTALA 0.5 mL aliquot of spermatozoa suspended in HTF-modified HEPES buffer, obtained either after sperm wash to remove the seminal plasma or after DGC, was centrifuged and the pellet (maximum of 107 cells) was resuspended in 80 uL of binding buffer with 20 uL of Annexin V-conjugated microspheres, both from the Annexin V microbead kit (Miltenyi Biotec, Huburn, CA, USA), for 15 min at room temperature. After addition of 400 lL of binding solution, the suspension was placed in the separation column (MiniMACS, Miltenyi Biotec). Labeled (apoptotic) cells were retained on the column and non-labeled (viable) cells passed through the column.
Interventions
MACS is a technique which allows the spermatozoa with the best characteristics to be selected for use in assisted reproduction treatments. This technique removes apoptotic spermatozoa - those which will die without achieving fertilisation - and selects the healthy ones, thus increasing the possibility of pregnancy.
Eligibility Criteria
You may qualify if:
- Patients were diagnostic as infertile according to 2007 WHO guidelines;
- DFI\>25%.
You may not qualify if:
- With obvious female infertile factors;
- Sperm count \<10 million;
- Chromosomal abnormalities in either or both of the couple;
- Loss of follow up or incomplete information of patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Li-jun Dinglead
Study Sites (1)
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 28, 2019
First Posted
May 30, 2019
Study Start
May 20, 2019
Primary Completion
April 30, 2020
Study Completion
July 19, 2020
Last Updated
May 30, 2019
Record last verified: 2019-05