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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03968367
Other study ID # SZ-2018-MASS1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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