The aim of this study is effect of medroxyprogesterone acetate compared with Cetrotide to prevent premature LH sudden increase in IVF cycles. Women between 20 and 40 years old with a diagnosis of primary infertility that are candidates for IFV and have been referred to the Infertility Center of Alzahra hospital will be studied. Patients will be divided randomly into two groups of 50 persons. In the intervention group, rFSH (recombinant FSH) at a dose of 225-150 units and medroxyprogesterone acetate (MPA) daily dose mg 10, the third day given cycle. In the control group (diet stimulation with agonists), gonadotropin stimulation done on the third day of the menstrual cycle. Treatment with a dose of 225-150 IU is the third day cycle. Examined the embryos, the number and regularity of blastomeres and fragmentation of the embryo on the third day according to the criteria. Treatment with a dose of 225-150 IU is the third day cycle. After 6-5 days of gonadotropin stimulation, transvaginal ultrasound is performed and then repeated every 3-2 days is based on the patient's condition. The number and regularity of blastomeres and embryos Embryonic degree of fragmentation on the third day according to the search criteria. The number of oocyte and embryo formation and their grades and pregnancy outcomes in the two groups will be compared. Treatment with estradiol and progesterone in hormone cycles and natural cycles of treatment with progesterone in the tenth week of pregnancy continues. If no response and lack of follicle growth cycle and the cycle canceled the results will be canceled.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010813566N8
Registration date:2017-01-30, 1395/11/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-30, 1395/11/11
Registrant information
Name
Kobra Hamdi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
hamdik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Expected recruitment start date
2017-01-27, 1395/11/08
Expected recruitment end date
2018-01-28, 1396/11/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of medroxyprogesterone acetate compared with Cetrotide to prevent premature LH sudden increase in IVF cycles
Public title
Effect of medroxyprogesterone acetate compared with Cetrotide to prevent premature LH sudden increase in IVF cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women aged 40-20 years; AFC top four on the third day of the menstrual cycle; The base FSH less than IU / L15;
Exclusion criteria: Evidence of ovarian failure (the top FSH IU / L15 or absence of ultrasound AFC on the third day of the menstrual cycle); Endometriosis grade 3 and 4; Any contraindications for ovarian stimulation; Severe male factor
Age
From 20 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
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 Tabriz University Of Medical Sciences.
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.TBZMED.REC.1395.1127
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Determination of serum levels of LH
Timepoint
On the third day of the cycle
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
In the control group (diet stimulation with agonists), gonadotropin stimulation done on the third day of the menstrual cycle. At a dose of 225-150 IU rFSH treatment cycle is performed on the third day. After 6-5 days of gonadotropin stimulation, transvaginal ultrasound is performed and then repeated every 3-2 days is based on the patient's condition
Category
Treatment - Drugs
2
Description
In the intervention group: (recombinant FSH) at a dose of 225-150 units and medroxyprogesterone acetate (MPA) daily dose mg 10, the third day given cycle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
DR.Hamdi Kobra
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
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,Tabriz 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
Tabriz University Of Medical Sciences
Full name of responsible person
Hamdi Kobra
Position
Associate Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Kobra Hamdi
Position
Associate Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Kobra Hamdi
Position
Associate Professor of Obstetrics Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)