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

Infertility, Male Clinical Trial

— MASS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03968367
• Other study ID #: SZ-2018-MASS1
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: July 19, 2020

Study information

• Verified date: May 2019
• Source: Nanjing University
• Contact: Haixiang Sun, phD
• Phone: +86 2583107188
• Email: stevensunz[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 19, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

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.

Locations

Country	Name	City	State
China	Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Li-jun Ding

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Live-birth rate	Live birth rate was defined as the number of deliveries that resulted in a live born neonate.	1year