Effect of calcium ionophore on fertilization and pregnancy rate in infertile patients with teratospermia candidate for Intracytoplasmic sperm injection
The aim of this prospective randomized controlled study is evaluating the effect calcium ionophore on fertilization and pregnancy rate in infertile men suffer teratospermia .
Inclusion criteria: Teratospermic men with normal morphology less than 14%, who are candidate for Intracytoplasmic sperm injection
Exclusion criteria: women older than 40 years; women with FSH higher than 12; immature oocytes
Three hundred oocyte (150 each group) from womem with teratospermic partner, who are candidate for Intracytoplasmic sperm injection will be chosed from April till March 2012.
In control group usual Intracytoplasmic sperm injection will be performed.
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, Chemical pregnancy, Chemical pregnancy
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012112610328N1
Registration date:2012-11-26, 1391/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-26, 1391/09/06
Registrant information
Name
Sima Janati
Name of organization / entity
Research and Clinical Center for Infertility, Dezful University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 9781
Email address
janati@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd
Expected recruitment start date
2012-04-02, 1391/01/14
Expected recruitment end date
2013-03-18, 1391/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of calcium ionophore on fertilization and pregnancy rate in infertile patients with teratospermia candidate for Intracytoplasmic sperm injection
Public title
Effect of calcium ionophore on oocyte activation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Teratospermic men with normal morphology less than 14%,who are candidate for Intracytoplasmic sperm injection
Exclusion criteria:women older than 40 years;women with FSH higher than 12; immature oocytes
Age
From 18 years old to 39 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
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
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bouali Ave, Safayeh, Research and Clinical Center for Infertility, Yazd
City
Yazd
Postal code
Approval date
2012-03-15, 1390/12/25
Ethics committee reference number
3770
Health conditions studied
1
Description of health condition studied
Male Infertility
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Fertilization rate
Timepoint
16-18 houres
Method of measurement
Observation with microscope
2
Description
Clinical pregnancy
Timepoint
2-3 weeks after positive B-hCG
Method of measurement
Observation of fetal heart activity by transvaginal ultrasonography
3
Description
Chemical pregnancy
Timepoint
After 14 days of embryo transfer
Method of measurement
Measurement of serum B-hCG
Secondary outcomes
1
Description
Cell division
Timepoint
Two days
Method of measurement
Observation with microscope
2
Description
Emberyo quality
Timepoint
Two days
Method of measurement
Observation by microscope according to the symmetrics and exact of Blastomer pieces
Intervention groups
1
Description
In intervention group (n=150 oocyte ) 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, Chemical pregnancy, Chemical pregnancy
Category
Treatment - Drugs
2
Description
In control(n=150 oocyte ) 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 ,Yazd
Full name of responsible person
Dr. Maryam Eftekhar
Street address
Boali Ave, Safayeh , Research and Clinical Center for Infertility,Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vise Chancellor of Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Dr. Maryam Eftekhar
Street address
Bouali Ave, Safayeh, Research and Clinical Center for Infertility, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vise Chancellor of Shahid Sadoughi University of Medical Sciences, Yazd
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
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Dr. Sima Janati
Position
Assisted professor of Obstetrics and Gynecology, fellowship of infertility in state of training
Other areas of specialty/work
Street address
Bouali Ave, Safayeh، Research and Clinical Center for Infertility, Yazd
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
janati@dums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences , Yazd
Full name of responsible person
Dr. Maryam Eftekhar
Position
Assisted Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Bouali Ave, Safayeh، Research and Clinical Center for Infertility, Yazd
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Dr. Sima Janati
Position
Assisted professor of Obstetrics and Gynecology, fellowship of infertility in state of training
Other areas of specialty/work
Street address
Bouali Ave, Safayeh, Research and Clinical Center for Infertility, Yazd
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
janati@dums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)