Study of the expression of genes involved in the process of apoptosis in cellulose cells in four groups of patients under the cycle of ovulation stimulation with antagonist or agonist GNRH with HP-FSH or FSH recombinant.
Examines the gene expression associated with progression and development and the quality of the resulting embryos in common methods in the induction of ovulation.
Design
Eighty eligible infertile patients underwent controlled ovarian stimulation using agonists and antagonists (in both recombinant and HP groups) will be placed in phase 2-3 non-random clinical trials.
Settings and conduct
Eligible infertile patients in Vali Asr Infertility Clinic of Imam Khomeini Hospital with the aim of; Investigation ovarian gene expression in four treatment groups (non-random) will be studied. As mentioned in the four treatment groups, the egg pick up is performed 36 hours after the last administration of therapy. Then cumulus cells of oocytes are isolated by adding a drop of the enzyme hyaluronidase and In oocyte, without cumulus cells, the expression of genes is read by PCR in all four treatment groups.
Participants/Inclusion and exclusion criteria
Infertile women 20-30 years old will include the study with proper ovarian response and the absence of unknown infertility, azoospermia, and ovarian hyperstimulation syndrome.
Intervention groups
In this study, four groups of 20 infertile women (ovulation stimulation) will include in the study. The first group: Agonist GnRH and FSH (HP); Group 2:Agonist GnRH and FSH (recombinant),group 3: Antagonist GnRH and FSH (HP) and Group 4: Antagonist GnRH and FSH (recombinant). In all intervention groups; The eggs are aspirated from the follicular fluid and rinsed several times, then a drop of hyaluronidase is added to them and the cumulus is separated.Gene extracts from Cumulus, At this stage, the first RNA is extracted and then C DNA; It is synthesized and used; Gene expression evaluation is used using real-time PCR method.
Main outcome variables
Egg maturation; Fertilization success rate; The rate of fetal development are the main outcomes of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101115005181N16
Registration date:2020-06-12, 1399/03/23
Registration timing:registered_while_recruiting
Last update:2020-06-12, 1399/03/23
Update count:0
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Batool Rashidi
Name of organization / entity
Vali E Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
bhrashidi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-01, 1399/03/12
Expected recruitment end date
2020-11-02, 1399/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the expression of genes involved in the process of apoptosis in cellulose cells in four groups of patients under the cycle of ovulation stimulation with antagonist or agonist GNRH with HP-FSH or FSH recombinant.
Public title
Study of the expression of genes involved in the process of death in oocytes in four groups of patients undergoing ovulation stimulation cycle with four therapies.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
The age of 20- 30 years old.
Normal response to induction of ovulation.
Exclusion criteria:
unexplained infertility Cause
Azoospermia
Ovarian hyper stimulation Syndrome
Age
From 20 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not 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 Tehran University of Medical Sciences
Street address
Sixth floor, Deputy of Research and Technology, Central University Organization, Quds Street, , Keshavarz Boulevard,
City
Tehran
Province
Tehran
Postal code
14197-33141
Approval date
2017-06-02, 1396/03/12
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2309
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Maturation of Oocyte
Timepoint
36 hours after the last administration of treatment
Method of measurement
Electronic Microscope
2
Description
Fertilization rate
Timepoint
24 hours after intra cytoplasmic sperm injection
Method of measurement
Electronic Microscope
3
Description
Rate of Embryo development
Timepoint
The third day of intra cytoplasmic sperm injection
Method of measurement
Electronic Microscope
4
Description
The evaluation of Gene expression of HAS-2, BAX, BCL-2, VCAN, ALCAM, R PTGS-2 in cumulus of oocyte
Timepoint
The day of pick up ovum
Method of measurement
Real time PCR
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: 20 infertile patients who were stimulated using the Gnrh agonist ampoule (Cinafact) of Cinagen Company, from the 21th day of previous cycle , 20 IU subcutaneous daily up to 36 hours before oocyte pick up and 225 units FSH (HP) of Cinagen company from the third day of menstrual cycle, are administrated for at least 10 days.
Category
Treatment - Drugs
2
Description
The second intervention group: 20 infertile patients who were stimulated using the Gnrh agonist ampoule (Cinafact) of Cinagen Company, from the 21th day of previous cycle , 20 IU subcutaneous daily up to 36 hours before oocyte pick up and 225 units FSH (Recombinant) of Cinagen company from the third day of menstrual cycle, are administrated for at least 10 days.
Category
Treatment - Drugs
3
Description
The third intervention group: 20 infertile patients who were stimulated using the Gnrh antagonist ampoule (cetrotide) of Merck Company, from the 6th day of induction ovulation, 0.25 IU subcutaneous daily up to 36 hours before oocyte pick up and 225 units FSH (HP) of Cinagen company from the third day of menstrual cycle, are administrated for at least 10 days.
Category
Treatment - Drugs
4
Description
The Fourth intervention group: 20 infertile patients who were stimulated using the GnRH antagonist ampoule (cetrotide) of Merck Company, from the 6th day of induction ovulation, 0.25 IU subcutaneous daily up to 36 hours before oocyte pick up and 225 units FSH (recombinant) of Cinagen company from the third day of the menstrual cycle, are administrated for at least 10 days. In all intervention groups of 1-4; The eggs are aspirated from the follicular fluid and rinsed several times, then a drop of hyaluronidase is added to them and the cumulus is separated.Gene extract from Cumulus, At this stage, first RNA is extracted and then C DNA; It is synthesized and used; Gene expression evaluation is used using real-time PCR method.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
IVF Labratoary in Vali- Asr Hospital
Full name of responsible person
Said Azizollahi
Street address
IVF Labratoary, Vali- Asr Hospital, Blvd Keshavarz
City
Tehran
Province
Tehran
Postal code
141993317
Phone
+98 21 6658 1616
Fax
Email
saeedazizollahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Sixth floor, Quds Street, Keshavarz Boulevard, Central University Organization, Deputy of Research and Technology
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Fax
+98 21 8163 3623
Email
vcr@tums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeed Azizollahi
Position
Reproductive Biology Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
IVF Labratoary, Vali- Asr Hospital, Blvd Keshavarz.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
saeedazizollahi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Batool Hossein Rashidi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vali-e-Asr Reproductive Health Research Center, Imam Hospital Complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
bhrashidi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fedyeh Haghollahi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Vali-e-Asr Reproductive Health Research Center, Imam Hospital Complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
fedyeh_hagh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available