Objectives: Comparison of the effect of strontium chloride with calcium ionophore (Ionomycin) on intra cytoplasmic sperm injection (ICSI) clinical outcomes.
Design: 105 couple’s candidate of ICSI and artificial oocyte activation (AOA) with male factor infertility that referred to the Isfahan Fertility and Infertility Center ( IFIC), are included in this study. All of the patients provided written informed consent and counseled regarding the AOA procedure and type of chemicals (ionomycin and strontium chloride). Based on treatment procedure, this single - blind clinical trial is designed that embryologist, is blinded regarding the groups and type of chemical stimuli used for AOA.
Intervention: In “study group”, injected oocytes from each couples are randomly divided into two groups, one group are activated with 10 µM Ionomycin and the oocytes in the other group, activated with 10 mM strontium chloride.
In “external control group”, all of the injected oocytes were artificially activated by exposure to 10 µM Ionomycin.
Major Inclusion and Exclusion 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.
Main outcome measures (variables): This is the first clinical trial that are designed to compare the effect of strontium chloride with calcium ionosphere on ICSI clinical outcomes for example fertilization rate, embryo quality and pregnancy rates.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510257223N7
Registration date:2015-12-02, 1394/09/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Mohammad Hossein Nasr-Esfahani
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Country
Iran (Islamic Republic of)
Phone
+98 31 9501 5688
Email address
mh_nasr@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Royan Institute, Dr. Abdolhossein Shahverdi
Address: Hafez St, Banihashem Ave, Resalat Highway, Tehran, Iran, Royan Institute
Telephone: 00982123562674
Expected recruitment start date
2014-09-25, 1393/07/03
Expected recruitment end date
2015-12-11, 1394/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Clinical Outcomes of Activated Oocyte with Ionomycin and Strontium Chloride in Intra Cytoplasmic Sperm Injection Candidates
Public title
Evaluation of Clinical Outcomes of Artificial Oocyte Activation in Intra Cytoplasmic Sperm Injection Candidates
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 20 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Royan Institute
Street address
Hafez St, Banihashem Ave, Resalat Highway, Tehran, Iran, Royan Institute
City
Tehran
Postal code
Approval date
2015-03-14, 1393/12/23
Ethics committee reference number
EC/93/1104
Health conditions studied
1
Description of health condition studied
Male factor infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Sperm concentration
Timepoint
In daye of ICSI procedure
Method of measurement
Light microscopy according to (WHO, 2010) criteria
2
Description
Sperm motility
Timepoint
In daye of ICSI procedure
Method of measurement
Light microscopy according to (WHO, 2010) criteria
3
Description
Sperm morphology
Timepoint
In daye of ICSI procedure
Method of measurement
Light microscopy according to (WHO, 2010) criteria
4
Description
Fertilization rate
Timepoint
16 - 20 h after injection
Method of measurement
View of two pronuclei with invert microscope
5
Description
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
6
Description
Chemical pregnancy
Timepoint
14 days after ET (Embryo Transfer)
Method of measurement
Measurement of quantitative serum β-hCG
7
Description
Clinical pregnancy
Timepoint
5 - 6 weeks following ET
Method of measurement
Ultrasound detection of an intrauterine gestational sac with a positive fetal heartbeat
Secondary outcomes
empty
Intervention groups
1
Description
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), 30 minutes post-ICSI, for 60 minutes.
Category
Other
2
Description
Internal control group: The oocytes in the other group, are activated 10 µM Ionomycin immediately after ICSI in G1 medium for 10 minutes
Category
Other
3
Description
External control group: The injected oocytes are artificially activated with 10 µM Ionomycin in G1 medium for 10 minutes immediately post-ICSI.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Fertility and Infertility Center
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Street address
Salman Farsi St, Isfahan, Iran, Fertility and Infertility Center
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Vice Chancellor for Research of Royan Institute, Dr. Abdolhossein Shahverdi
Street address
Hafez St, Banihashem Ave, Resalat Highway, Tehran, Iran, Royan Institute
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Position
Professor, Head of Royan Institute for Biotechnology
Other areas of specialty/work
Street address
Royan St, Salman St, Khorasgan, Isfahan, Iran, Royan Institute for Biotechnology
City
Isfahan
Postal code
Phone
+98 31 9501 5688
Fax
Email
mh_nasr@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Position
Professor, Head of Royan Institute for Biotechnology
Other areas of specialty/work
Street address
Royan St, Salman St, Khorasgan, Isfahan, Iran, Royan Institute for Biotechnology
City
Isfahan
Postal code
Phone
+98 31 9501 5688
Fax
Email
mh_nasr@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Position
Professor, Head of Royan Institute for Biotechnology
Other areas of specialty/work
Street address
Royan St, Salman St, Khorasgan, Isfahan, Iran, Royan Institute for Biotechnology
City
Isfahan
Postal code
Phone
+98 31 9501 5688
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)