To Study the Effect of Magnetic Activated Sperm Sorting on the Outcome of in Vitro Fertilization-embryo Transplantation (MASS)

To Study the Effect of Magnetic Activated Sperm Sorting on the Outcome of in Vitro Fertilization-embryo Transplantation Among Patients With High DNA Fragmentation Index

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).

Study Overview

• Status: Unknown
• Conditions: Infertility, Male
• Intervention / Treatment: Procedure: Magnetic activated sperm sorting

Detailed Description

Patients will be recruited from our reproductive medicine center in Nanjing Drum towel Hospital, from July 2019 to July 2020. After semen analysis and selection of infertile men with at least two abnormal sperm parameters and obtaining the informed consent of the patients according to the admission criteria, the patients who enter the project will be randomly divided into the control group (n=30) whose sperm will be screened by density differential centrifugation (DGC) with swim up, and the observation group will be screened by MASS, followed by DGC. Then the procedure of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) will be performed. Embryo transfer will be underwent according to the developmental speed and morphological characteristics of the embryo. The clinical outcomes after transplantation will be followed up.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patients were diagnostic as infertile according to 2007 WHO guidelines;
• DFI>25%.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Magnetic activated sperm cell sorting for infertile man; A 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.

Procedure: Magnetic activated sperm sorting; 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.; Other Names: Magnetic activated cell sorting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Li-jun Ding

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2019
• Primary Completion (ANTICIPATED): April 30, 2020
• Study Completion (ANTICIPATED): July 19, 2020

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (ACTUAL): May 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: clinical outcome; DNA fragmentation index; magnetic activated sperm sorting; sperm up; density differential centrifugation
• Additional Relevant MeSH Terms: Infertility; Infertility, Male
• Other Study ID Numbers: SZ-2018-MASS1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No