Comparison of effect of calcium ionophore on oocyte activation in infertile patient with normal sperm morphology and low fertilization after microinjection
The aim of this prospective randomized controlled study is evaluating the effect calcium ionophore on fertilization and pregnancy rate in patients with history of fertilization rate less than 50% in previous micro injection cycle and normal sperm morphology who are candidate for Intracytoplasmic sperm injection Exclusion criteria:women older than 40 years; women with FSH higher than 12; history of endocrine disorder. In intervention group after oocytes retrieval, they will be entered to culture media plus 5 mic/ml calcium ionophore for 5 minutes, and then will be washed at least 5 time by mops solution. After 16-18 hours they will be evaluated for fertilization. Primary outcomes: Fertilization rate, secondary outcomes: Chemical pregnancy, Clinical pregnancy
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501266420N12
Registration date:2015-10-20, 1394/07/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-20, 1394/07/28
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of calcium ionophore on oocyte activation in infertile patient with normal sperm morphology and low fertilization after microinjection
Public title
Effect of adding calcium ionophore on medium of oocyte
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with history of fertilization less than 50% in previous micro injection cycle, who are candidate for Intracytoplasmic sperm injection and morphology of sperm is normal. Exclusion criteria:women older than 40 years; women with FSH higher than 12; history of endocrine disorder
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Science
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
YAZD
Postal code
8916877391
Approval date
2015-08-02, 1394/05/11
Ethics committee reference number
IR.SSU.RSI.REC.1394.3
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
fertilization rat
Timepoint
16-18 hour
Method of measurement
Observation with microscope
Secondary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
serum βhCG
2
Description
clinical pregnancy
Timepoint
3 weeks after positive serum βhCG
Method of measurement
vaginal ultrosonography
Intervention groups
1
Description
in intervention group 5 mmol/ml calcium ionophore in medium culture, immediately after ICSI, for 5 minutes and then washed at least 5 time by mops solution.
Category
Treatment - Drugs
2
Description
In control group usual Intracytoplasmic sperm injection will be performed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science
Full name of responsible person
Dr.Maryam Eftekhar, Associated Professor of Shahid Sadoughi University of medical science
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.Abass Aflatounian
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Sadoughi University of Medical Sciences
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
Sadoughi University of Medical Science ,Yazd
Full name of responsible person
Maryam Eftekhar
Position
Associated Professor
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
eftekharmaryam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sadoughi University of Medical Science
Full name of responsible person
Dr Maryam Eftekhar
Position
Associated Professor
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
eftekharmaryam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sadoughi University of Medical Science
Full name of responsible person
Maryam Eftekhar
Position
Associated professor
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
eftekharmaryam@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)