Evaluation of Clinical Outcomes of Artificial Oocyte Activation in Intra Cytoplasmic Sperm Injection Candidates

Comparison of Clinical Outcomes of Activated Oocyte with Ionomycin and Strontium Chloride in Intra Cytoplasmic Sperm Injection Candidates

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201510257223N7

Enrollment

105

Registered

2015-12-02

Start date

2014-09-25

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: Intervention or study group: Sibling oocytes are split into two groups: one group are artificially activated with 10 mM strontium chloride in GPGD medium (Calcium- and Magnesium-free M

Intervention or study group: Sibling oocytes are split into two groups: one group are artificially activated with 10 mM strontium chloride in GPGD medium (Calcium- and Magnesium-free MOPS buffered), 3

Internal control group: The oocytes in the other group, are activated 10 µM Ionomycin immediately after ICSI in G1 medium for 10 minutes

External control group: The injected oocytes are artificially activated with 10 µM Ionomycin in G1 medium for 10 minutes immediately post-ICSI.

Eligibility

Sex/Gender

All

Age

20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Infertile couples with male factor etiology showing 99-100 % abnormal sperm morphology Exclusion Criteria: Females with higher than 45, with less than 6 matured oocytes, immature, deformed.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sperm concentration. Timepoint: In daye of ICSI procedure. Method of measurement: Light microscopy according to (WHO, 2010) criteria.;Sperm motility. Timepoint: In daye of ICSI procedure. Method of measurement: Light microscopy according to (WHO, 2010) criteria.;Sperm morphology. Timepoint: In daye of ICSI procedure. Method of measurement: Light microscopy according to (WHO, 2010) criteria.;Fertilization rate. Timepoint: 16 - 20 h after injection. Method of measurement: View of two pronuclei with invert microscope.;Quality of embryo. Timepoint: Three days after injection. Method of measurement: Using a three-point scoring system including fragmentation rate, number of blastomere, shape and size.;Chemical pregnancy. Timepoint: 14 days after ET (Embryo Transfer). Method of measurement: Measurement of quantitative serum ß-hCG.;Clinical pregnancy. Timepoint: 5 - 6 weeks following ET. Method of measurement: Ultrasound detection of an intrauterine gestational sac with a positive fetal heartbeat.	—

Measure

Time frame

Sperm concentration. Timepoint: In daye of ICSI procedure. Method of measurement: Light microscopy according to (WHO, 2010) criteria.;Sperm motility. Timepoint: In daye of ICSI procedure. Method of measurement: Light microscopy according to (WHO, 2010) criteria.;Sperm morphology. Timepoint: In daye of ICSI procedure. Method of measurement: Light microscopy according to (WHO, 2010) criteria.;Fertilization rate. Timepoint: 16 - 20 h after injection. Method of measurement: View of two pronuclei with invert microscope.;Quality of embryo. Timepoint: Three days after injection. Method of measurement: Using a three-point scoring system including fragmentation rate, number of blastomere, shape and size.;Chemical pregnancy. Timepoint: 14 days after ET (Embryo Transfer). Method of measurement: Measurement of quantitative serum ß-hCG.;Clinical pregnancy. Timepoint: 5 - 6 weeks following ET. Method of measurement: Ultrasound detection of an intrauterine gestational sac with a positive fetal heartbeat.

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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 4, 2026