Comparison of fertilization percentage, embryo quality, implantation and pregnancy rate, between two sperm separation procedures in infertile men intra-cytoplasmic sperm injection candidate

Comparison of fertilization percentage, embryo quality, pregnancy and implantation rate, between two sperm separation procedures (density gradient centrifugation with surface markers- density gradient centrifugation) in infertile men intra-cytoplasmic sperm injection candidate

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201610317223N8

Enrollment

113

Registered

2017-08-22

Start date

2015-04-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Male factor infertility. Male infertility

Interventions

Intervention 1: In study group, total of oocytes were inseminated with sperm that selected with DGC following MACS processing (Separate intact spermatozoa from those that present apoptotic markers by

In study group, total of oocytes were inseminated with sperm that selected with DGC following MACS processing (Separate intact spermatozoa from those that present apoptotic markers by magnetic particl

In control group (DGC group), oocytes were inseminated with sperm selected by Density gradient centrifugation method (based on viability and morphology). Density gradient centrifugation was prepared b

Eligibility

Sex/Gender

All

Age

20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Primary male factor infertility (according to the WHO-2010); with mean age of 20-45. Exclusion criteria: Females factor infertility based on WHO criteria (2010); age higher than 35 years; less than 6 oocytes and poor quality oocyte

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Fertilization rate. Timepoint: 16-18 h post insemination/injection. Method of measurement: View of 2 pronucleuse with invert microscope,the ratio of fertilized oocytes (2PN) by the total number of injected metaphase II oocytes, multiplied by 100.;Implantation rate. Timepoint: 4 weeks after transfer. Method of measurement: The number of observed gestational sacs per number of transferred.;Chemical pregnancy. Timepoint: 18 days post-ICSI. Method of measurement: Measurement of Beta HCG level in serum.;Clinical pregnancy. Timepoint: 5 weeks after embryo transfer. Method of measurement: ultrasonography findings showing at least one embryo with a fetal heartbeat.;Quality of embryo. Timepoint: On day 3 after oocyte retrieval. Method of measurement: Using a three-point scoring system including fragmentation rate, number of blastomere, shape and size.	—

Measure

Time frame

Fertilization rate. Timepoint: 16-18 h post insemination/injection. Method of measurement: View of 2 pronucleuse with invert microscope,the ratio of fertilized oocytes (2PN) by the total number of injected metaphase II oocytes, multiplied by 100.;Implantation rate. Timepoint: 4 weeks after transfer. Method of measurement: The number of observed gestational sacs per number of transferred.;Chemical pregnancy. Timepoint: 18 days post-ICSI. Method of measurement: Measurement of Beta HCG level in serum.;Clinical pregnancy. Timepoint: 5 weeks after embryo transfer. Method of measurement: ultrasonography findings showing at least one embryo with a fetal heartbeat.;Quality of embryo. Timepoint: On day 3 after oocyte retrieval. Method of measurement: Using a three-point scoring system including fragmentation rate, number of blastomere, shape and size.

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Secondary

Measure	Time frame
Perinatal mortality ( fetal or neonatal death). Timepoint: At 20 completed weeks of gestational age and later, during childbirth, or up to 7 completed days after birth. Method of measurement: Through ultrasound.;Miscarriage (The spontaneous loss of a clinical pregnancy ). Timepoint: Before 20 completed weeks of gestational age (18 weeks after fertilization). Method of measurement: Through ultrasound.	—

Measure

Time frame

Perinatal mortality ( fetal or neonatal death). Timepoint: At 20 completed weeks of gestational age and later, during childbirth, or up to 7 completed days after birth. Method of measurement: Through ultrasound.;Miscarriage (The spontaneous loss of a clinical pregnancy ). Timepoint: Before 20 completed weeks of gestational age (18 weeks after fertilization). Method of measurement: Through ultrasound.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hossein Nasr-Esfahani

Royan Institute (Royan Institute for Biotechnology)

mh_nasr@med.mui.ac.ir+98 31 9501 5688

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 13, 2026