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Comparison of clinical outcomes between two sperm separation procedures: Felix vs. DGC

Comparison of clinical outcomes of infertile men candidate for ICSI between two methods of sperm separation: Felix device based on surface electric charge and density gradient centrifugation (DGC)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110804007223N11
Enrollment
100
Registered
2022-06-09
Start date
2022-06-01
Completion date
Unknown
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sperm selection procedure. Male infertility

Interventions

Intervention 1: For each semen sample, two procedures will be carried out for sperm preparation. One of the procedures (Control) will be used for half of the sibling oocytes, and another procedure (st
Sweden).2. Reservoir chambers (2) – 4mls of G-Rinse (Vitrolife
Sweden) in each (8mls total). The selected sperm will then be collected from the harvest chamber based on the electric charge, and the sper
Sweden) will be transferred on 1ml of 80% PureSperm gradient (Vitrolife
Sweden) into a conical centrifuge tube. Then, 1ml of liquefied semen sample will be placed on the top of the upper layer, and the tube Will be centrifuged for 20 min at 1000rpm. The upper and lower la

Sponsors

Royan Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 38 Years

Inclusion criteria

Inclusion criteria: Couples candidate for ICSI The number of follicles: at least 10 MII oocytes. Infertile couples with male factor infertility (sperm parameters lower than defined threshold by WHO 2021) Female age = 38 years Men with at least 2ml semen Embryo transfer only at blastocyst stage One blastocyst for transfer Normal female (female will be considered as normal if they have a regular cycle with patent tube and absence of endometriosis ) Men with a total sperm cell count higher than 5 million per ejaculate

Exclusion criteria

Exclusion criteria: Men with testicular sperm extraction or epididymal sperm aspiration Men with cryo-preserved semen samples

Design outcomes

Primary

MeasureTime frame
Blastocysts rate and quality. Timepoint: Day 5 or 6 after ICSI. Method of measurement: Microscope.

Secondary

MeasureTime frame
Fertilization. Timepoint: 16-18 hours after ICSI. Method of measurement: The number of 2PNs divided by the number of MII oocytes injected by ICSI multiplied by 100.;Embryo quality. Timepoint: 2 or 3 day after ICSI. Method of measurement: According to DK Gardner criteria (2016).;Biochemical pregnancy. Timepoint: Post implantation. Method of measurement: Beta hCG level.;Clinical pregnancy. Timepoint: Fifth or sixth week of pregnancy. Method of measurement: The observation of a fetal sacs and also fetal heartbeat by sonography.;Implantation. Timepoint: One to two weeks after blastocyst transfer. Method of measurement: Sonography.;Livebirth. Timepoint: At the time of delivery. Method of measurement: By phone call.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hossein Nasr-Esfahani

Royan Institute

nasr.royan@gmail.com+98 31 9501 5682

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026