Controlled trial of comparison of the effect of controlled ovarian stimulation protocols on gene expression of germinal vesicle oocytes in infertile women
The objective of the present study is to compare the expression of genes in germinal vesicle oocyte between receiving the gonadotropin releasing hormone antagonist (GnRH-ant) and gonadotropin releasing hormone agonist (GnRH-a) long protocols in controlled ovarian stimulation of infertile women. Inclusion criteria include: age 18-40 years; normal serum level of steroidal hormones; male infertility, tubal factor infertility unexplained infertility. Exclusion criteria include: poly cystic ovarian; moderate or severe endometriosis and genetic disease. Fifty infertile women undergo controlled ovarian stimulation with either the GnRH-a long protocol or GnRH-ant fixed multi-dose protocol, randomly. One hundred morphologically healthy germinal vesicle (GV) oocytes donated by fifty infertile women will collect in the Infertility center of Tehran Women General Hospital, Tehran University of Medical Sciences, Iran. After the sampling, pools of fifty GV oocytes for each group will separately analyz by Real time PCR. Finally we will assess the expression levels of genes involved in the cytoplasmic maturity: growth and differential factor 9 (GDF9) and bone morphogenetic protein 15 (BMP15); antiapoptotic process: neuronal apoptosis inhibitory protein (NAIP), and adenosine triple phosphate 6 (ATPase 6) in human germinal vesicle oocytes in the GnRH-ant protocol group versus the GnRH-a long protocol group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031112307N3
Registration date:2014-04-21, 1393/02/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-21, 1393/02/01
Registrant information
Name
Fatemeh Sadat Hoseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8890 7062
Email address
fshoseini@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-09-20, 1391/06/30
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Controlled trial of comparison of the effect of controlled ovarian stimulation protocols on gene expression of germinal vesicle oocytes in infertile women
Public title
Controlled trial of comparison of the effect of controlled ovarian stimulation protocols on gene expression of germinal vesicle oocytes in infertile women
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: age 18-40 years; normal serum level of steroidal hormones; male infertility, tubal factor infertility and unexplained infertility.
Exclusion criteria: genetic diseases; moderate or severe endometriosis and poly cystic ovarian.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Vice chancellor for Research,Tehran University of Medical Sciences
Street address
Ghods St., Keshavarz Blvd., Teharn
City
Tehran
Postal code
1417653761
Approval date
2012-11-25, 1391/09/05
Ethics committee reference number
130/1743
Health conditions studied
1
Description of health condition studied
Contrlled Ovarian Stimulation protocols
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Determination of the effect of controlled ovarian stimulation protocols on gene expression of germinal vesicle oocytes in infertile women
Timepoint
ٍEnd of sampling
Method of measurement
Real Time PCR
Secondary outcomes
1
Description
Determination of the effect of controlled ovarian stimulation protocols on adenosine triphosphatase 6 gene expression of human germinal vesicle oocytes
Timepoint
The end of sampling
Method of measurement
Real Time PCR
2
Description
Determination of the effect of controlled ovarian stimulation protocols on growth differentiation factor 9 gene expression of human germinal vesicle oocytes
Timepoint
The end of sampling
Method of measurement
Real Time PCR
3
Description
Determination of the effect of controlled ovarian stimulation protocols on bone morphogenetic protein15 gene expression of human germinal vesicle oocytes
Timepoint
The end of sampling
Method of measurement
Real Time PCR
4
Description
Determination of the effect of controlled ovarian stimulation protocols on neuronal apoptosis inhibitory protein gene expression of human germinal vesicle oocytes
Timepoint
The end of sampling
Method of measurement
Real Time PCR
Intervention groups
1
Description
Control group: In the gonadotropin releasing hormone agonist long protocol group, the administration of Buserelin acetate 500 μg/d is started subcutaneously proceeding the IVF cycle from day 21 until pituitary down regulation. The Buserelin dose is reduced to 250 μg/d until the day of human chorionic gonadotropin (hCG) injection when pituitary down regulation was achieved. Ovarian stimulation is started on the 3rd day of the current menstrual cycle by injection of rFSH Follitropin alfa (Gonal F) at a daily dose of 150 to 225 IU/IM. Human chorionic gonadotropin 5000 IU /2/IM is injected about 34–36 hrs before oocytes pickup day.
Category
Treatment - Drugs
2
Description
Intervention group: In the gonadotropin releasing hormone antagonist fixed multi-dose protocol group, Cetrorelix acetate 0.25 mg/day subcutaneously is initiated on the sixth day of the gonadotropin stimulation until the day of hCG injection. Ovarian stimulation is started on the 3rd day of the current menstrual cycle by injection of rFSH Follitropin alfa (Gonal F) at a daily dose of 150 to 225 IU/IM until the day of human chorionic gonadotropin injection. Human chorionic gonadotropin 5000 IU /2/IM is injected about 34–36 hrs before oocytes pickup day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Women General Hospital
Full name of responsible person
Nasser Salsabili
Street address
North Negatollahi St., Karim Khan St., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotohi
Street address
Ghods St., Keshavarz Blvd., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Hossein Noori Mugahi
Position
Faculty member, PhD of Histology
Other areas of specialty/work
Street address
Histology Department, School of Medcine, Pour Sina St., Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 8895 3008
Fax
Email
Noorimoo@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hoseini
Position
Research Employee and Student PhD of Reproductive Biology
Other areas of specialty/work
Street address
Deputy of Research of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 8163 3619
Fax
Email
fshoseini@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hoseini
Position
Reasearch employee and candidate PhD of Reproductive Biology
Other areas of specialty/work
Street address
Deputy of Research of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
tehran
Postal code
00982181633619
Phone
+98 21 8163 3619
Fax
Email
fshoseini@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)