NCT03968367

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Li-jun Ding · Academic / Other
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Infertility, Male

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-20
• Primary completion: 2020-04-30
• Completion: 2020-07-19
• First posted: 2019-05-30
• Last updated: 2019-05-30

Locations

1 site across 1 country: China