Comparison of different medication protocols for in vitro fertilization to induce controlled ovarian stimulation on expression of Gremlin1 (GREM1), Hyaluronic acid Synthetase2 ( HAS2) and Prostaglandin synthetase2 ( PGS2) genes as markers of oocyte maturation in granulosa cells
Objective: Comparison of 4 protocols of ovulation induction in IVF for the expression of GREM1, HAS2 and PGS2 genes in granulosa cells as a probable determinant of oocyte maturation. Study design: The study will be performed on 200 infertile couples that need IVF with unexplained cause or male factor . The ovaries will be suppressed from the 21th day of the previous cycle and gonadotropin will be started from the 2nd day of the cycle up to the day of HCG injection using 4 methods. Group 1: will receive highly purified-human HMG, group 2: human-FSH, group 3: recombinant-FSH, group 4: human-FSH for 6 days followed by recombinant-FSH, respectively. All of the drugs will be started with the dose of 225 IU/day. The dose can be changed if needed after ultrasound scanning. Randomization will be performed according to the number of entrance of the cases in the study. HCG will be injected when follicles are mature. Estradiol level on HCG day, number of harvested Follicles and their quality, number and grade of embryos and clinical pregnancy rate will be evaluated. Granulosa cells will be separated and freezed in liquid nitrogen. The quantity of GREM1, HAS2 and PGS2 genes expression on granulose cells will be evaluated by PCR method and will be compared to the outcome measures between the four methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201046541N2
Registration date:2012-02-10, 1390/11/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-10, 1390/11/21
Registrant information
Name
Bahia Namavar Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
namavarb@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of Medical Sciences, Infertility research center
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of different medication protocols for in vitro fertilization to induce controlled ovarian stimulation on expression of Gremlin1 (GREM1), Hyaluronic acid Synthetase2 ( HAS2) and Prostaglandin synthetase2 ( PGS2) genes as markers of oocyte maturation in granulosa cells
Public title
Comparison of different medication protocols for induction of ovarian in the cycles of in vitro fertilization on expression of GREM 1, HAS2 and PGS2 genes as determinants of oocyte development
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertility with male factor or with unexplained cause. Exclusion criteria: all the cases with known female factor.
Age
From 20 years old to 38 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2011-12-19, 1390/09/28
Ethics committee reference number
CT-90-5874
2
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences , Zand Street
City
Shiraz
Postal code
Approval date
2011-12-19, 1390/09/28
Ethics committee reference number
CT-9o-5873
3
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2011-12-18, 1390/09/27
Ethics committee reference number
CT-90-5875
Health conditions studied
1
Description of health condition studied
male infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
2
Description of health condition studied
Female infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Number of oocytes
Timepoint
At the time of Harvesting the oocytes
Method of measurement
Counting the oocytes
2
Description
quality of oocytes
Timepoint
At the time of oocyte retrival
Method of measurement
based on quality grading(GV-MI-MII)
3
Description
embryo count
Timepoint
3 days after oocyte retrival
Method of measurement
microscopic evaluation
4
Description
Evaluation of expression of HAS2 Gene
Timepoint
after oocyte retrival
Method of measurement
Polymerase Chain Reaction (PCR)
5
Description
quantity of GREM1 expression
Timepoint
at the time of oocyte retrival
Method of measurement
PCR test
6
Description
Evaluation of expression of PGS2 Gene
Timepoint
after oocyte retrival
Method of measurement
Polymerase Chain Reaction (PCR)
Secondary outcomes
empty
Intervention groups
1
Description
group 1: highly purified-human HMG starting with the dose of 225 IU/day
Category
Treatment - Drugs
2
Description
group 2: human-FSH starting with the dose of 225 IU/day
Category
Treatment - Drugs
3
Description
group 3: recombinant-FSH starting with the dose of 225 IU/day
Category
Treatment - Drugs
4
Description
group 4: human-FSH for 6 days followed by recombinant-FSH starting with 225 IU/day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir hospital for mother and chilld
Full name of responsible person
Dr. Mohammad Ebrahim Parsanejhad
Street address
Shiraz university of Medical Sciences, Infertility research center
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of Medical Sciences, Infertility research center
Full name of responsible person
Dr. Jhale Zolghadr
Street address
Ghadir Hospital for Mother and Child, Infertility research center, Shiraz university of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of Medical Sciences, Infertility research center
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
Shiraz university of Medical Sciences, Infertility research center
Full name of responsible person
Dr. Bahia Namavar Jahromi
Position
Associate professor in Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Dep. of OB-GYN. Shahid Faghihi Hospital
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
namavarb@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of Medical Sciences, Infertility research center
Full name of responsible person
Dr. Mohammad Ebrahim Parsanejhad
Position
professor in Shiraz university of Medical Sciences
Other areas of specialty/work
Street address
Ghadir hospital for mother and child, Infertility research center, Shiraz university of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
parsame@rogers.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)