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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2020-07-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does DNA Sperm Fragmentation Affects Embryo Morphokinetic?

NCT02214537

Blastocyst Time Pronuclear Appearance Pronuclear Fading +2 more

TERMINATED NA

Selection of Non Apoptotic Human Sperm for in Vitro Fertilization by Using Magnetic Activated Cell Sorting (MACS)

NCT03988361

Infertility, Male

UNKNOWN

Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

NCT00702273

In Vitro Fertilization

COMPLETED

Sperm DNA Fragmentation Effects on Blastocyst Morphology Grading, Pregnancy Rate and Implantation Rate

NCT04144621

Blastocyst Implantation Rate

COMPLETED

Microfluidics Versus Density Gradient Centrifugation for Sperm Preparation in IVF

NCT07004309

Male Infertility Sperm DNA Fragmentation In Vitro Fertilization (IVF)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility, Male

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Magnetic activated sperm sorting

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Magnetic activated cell sorting

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No